Sunday, January 18, 2009

advisory regarding Gawad Kalikasan Inc. and its products; web sites with useful, free information

advisory regarding Gawad Kalikasan Inc.
and its products. The following allegations regarding said firm and its products were published in the Friday January 16, 2009 issue of the Philippine Daily Inquirer. The provider of said allegations was identified as Donna Cuna Pita. The complete
address of said Pita was not visible. Therefore, it will benefit customers not to believe any of the allegations published regarding said firm and its products. "Human Nature items are all organic, meaning no synthetic ingredients are used to
produce them. All ingredients are sourced from local farmers . . . we provide only the safest and purest world class ingredients for them . . . shares Anna."

U.S. FDA Drug Safety Newsletter Update
http://service.govdelivery.com/service/view.html?code=USFDA_21

FDA Alerts Public about Danger of Skin Numbing Products
http://www.fda.gov/bbs/topics/NEWS/2009/NEW01947.html

FDA Approves RiaSTAP for Treatment of Bleeding in Patients with Rare Genetic Defect
http://www.fda.gov/bbs/topics/NEWS/2009/NEW01948.html

U.S. Department of Health & Human Services
News and Information

* Hypothermia: A Cold Weather Risk for Older People (01/16)
* FDA Issues Guidances for Industry to Improve the Safety of Food, Feed and Drugs (01/15)


National Women's Health Information Center.
http://womenshealth.gov/faq/depression-pregnancy.cfm

new england journal of medicine web site
http://content.nejm.org/

Saturday, January 17, 2009

web sites with free useful information; FDA Expands Warning to Consumers About Tainted Weight Loss Pills

FDA Should Take Steps to Ensure That High-Risk Device Types Are Approved through the Most Stringent Premarket Review Process
http://www.gao.gov/new.items/d09190.pdf


web sites with useful information:

findingdulicinea web site
http://www.findingdulcinea.com/

TheLaptop Authority web site
http://www.thelaptopauthority.com/

50states web site
http://www.50states.com/

citizen org web site
http://www.citizen.org/

http://www.thebestmedicalcare.com/

living health web site
http://living.health.com/




http://www.fda.gov/bbs/topics/NEWS/2008/NEW01933.htmlFDA Expands Warning to Consumers About Tainted Weight Loss Pills
(Date Posted: 1/9/2009)

On January 8, 2009, the U.S. FDA expanded its nationwide alert to consumers about tainted weight loss pills that contain undeclared, active pharmaceutical ingredients. On December 22, 2008, FDA warned consumers not to purchase or consume 28 different products marketed for weight loss. Since that time, FDA analysis has identified 41 more tainted weight loss products that may put consumers’ health at risk.

An FDA analysis found that the undeclared active pharmaceutical ingredients in some of these products include sibutramine (a controlled substance), rimonabant (a drug not approved for marketing in the United States), phenytoin (an anti-seizure
medication), phenolphthalein (a solution used in chemical experiments and a suspected cancer causing agent) and bumetanide (a diuretic). Some of the amounts of active pharmaceutical ingredients far exceeded the FDA-recommended levels, putting
consumers' health at risk.

This press release was revised on January 8, 2009 to include updated information.
FDA News

FOR IMMEDIATE RELEASE
December 22, 2008

Media Inquiries:
Rita Chappelle, 240-753-8603
Consumer Inquiries:
888-INFO-FDA

FDA Expands Warning to Consumers About Tainted Weight Loss Pills
List increases from 28 to 69 products; Agency seeking recalls

The U.S. Food and Drug Administration is expanding its nationwide alert to consumers about tainted weight loss pills that contain undeclared, active pharmaceutical ingredients. On December 22, 2008, FDA warned consumers not to purchase or consume
28 different products marketed for weight loss. Since that time, FDA analysis has identified 41 more tainted weight loss products that may put consumers’ health at risk.

The tainted weight loss products are:

Fatloss Slimming


2 Day Diet


3x Slimming Power

Japan Lingzhi 24 Hours Diet


5x Imelda Perfect Slimming


3 Day Diet

7 Day Herbal Slim


8 Factor Diet


7 Diet Day/Night Formula

999 Fitness Essence


Extrim Plus


GMP

Imelda Perfect Slim


Lida DaiDaihua


Miaozi Slim Capsules

Perfect Slim


Perfect Slim 5x


Phyto Shape

ProSlim Plus


Royal Slimming Formula


Slim 3 in 1

Slim Express 360


Slimtech


Somotrim

Superslim


TripleSlim


Zhen de Shou

Venom Hyperdrive 3.0


Starcaps


Slim Waistline

Slim Waist Formula


Slim Up


Sliminate

Slim Fast


2x Powerful Slimming


Slim Express 4 in 1

Reduce Weihgt


Super Fat Burner


Super Slimming

Sana Plus


Trim 2 Plus


Powerful Slim

Waist Strength Formula


Slimming Formula


Perfect Slim Up

Slim Burn


Slim 3 in 1 Slim Formula


Slim 3 in 1 M18 Royal Diet

Slim 3 in 1 Extra Slim Waist Formula


Slim 3 in 1 Extra Slim Formula


Natural Model

2 Day Diet Slim Advance


Miaozi MeiMiaoQianZiJiaoNang


Meizitang

Meili


JM Fat Reducer


Imelda Fat Reducer

7 Days Diet


Extrim Plus 24 Hour Reburn


Fasting Diet

Cosmo Slim


Body Slimming


Body Shaping

Body Creator


BioEmagrecin


3 Days Fit

21 Double Slim


Eight Factor Diet


7 Diet

An FDA analysis found that the undeclared active pharmaceutical ingredients in some of these products include sibutramine (a controlled substance), rimonabant (a drug not approved for marketing in the United States), phenytoin (an anti-seizure
medication), phenolphthalein (a solution used in chemical experiments and a suspected cancer causing agent) and bumetanide (a diuretic). Some of the amounts of active pharmaceutical ingredients far exceeded the FDA-recommended levels, putting
consumers' health at risk.

These weight loss products, some of which are marketed as “dietary supplements,” are promoted and sold on various Web sites and in some retail stores. Some of the products claim to be “natural” or to contain only “herbal” ingredients, but actually
contain potentially harmful ingredients not listed on the product labels or in promotional advertisements. These products have not been approved by the FDA, are illegal and may be potentially harmful to unsuspecting consumers.

The FDA advises consumers who have used any of these products to stop taking them and consult their healthcare professional immediately. The FDA encourages consumers to seek guidance from a healthcare professional before purchasing weight loss products.

“These tainted weight loss products pose a great risk to public health because they contain undeclared ingredients and, in some cases, contain prescription drugs in amounts that greatly exceed their maximum recommended dosages,” said Janet

Woodcock, M.D., director, Center for Drug Evaluation and Research, FDA. “Consumers have no way of knowing that these products contain powerful drugs that could cause serious health consequences. Therefore FDA is taking this action to protect the
health of the American public.”

The FDA has inspected a number of companies associated with the sale of these illegal products, and is currently seeking product recalls. Based on the FDA’s inspections and the companies’ inadequate responses to recall requests, the FDA may take
additional enforcement steps, such as issuing warning letters or initiating seizures, injunctions, or criminal charges.

The health risks posed by these products can be serious; for example, sibutramine, which was found in many of the products, can cause high blood pressure, seizures, tachycardia (rapid heart beat), palpitations, heart attack or stroke. This drug can
also interact with other medications that patients may be taking and increase their risk of adverse drug events. The safety of sibutramine has also not been established in pregnant and lactating women, or in children younger than 16 years of age.

Rimonabant, another ingredient found in these products, was evaluated, but not approved by the FDA for marketing in the United States. The drug, which is approved in Europe, has been associated with increased risk of depression and suicidal
thoughts and has been linked to five deaths and 720 adverse reactions in Europe over the last two years.

Health care professionals and consumers should report serious adverse events (side effects) or product quality problems to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail, fax or phone.

* Online: www.fda.gov/MedWatch/report.htm
* Regular Mail: use postage-paid FDA form 3500 available at: www.fda.gov/MedWatch/getforms.htm and mail to MedWatch, 5600

Fishers Lane, Rockville, MD 20852-9787
* Fax: (800) FDA-0178
* Phone: (800) FDA-1088

Information for consumers can be found at:
http://www.fda.gov/cder/consumerinfo/weight_loss_products.htm

To learn more about FDA’s initiative against unapproved drugs read FDA’s Compliance Policy Guide here:

http://www.fda.gov/cder/Guidance/6911fnl.htm.

For drug safety information, read: FDA's Drug Safety Initiative



Kellogg Company Announces Precautionary Hold on Austin and Keebler Branded Peanut Butter Sandwich Crackers
http://www.fda.gov/oc/po/firmrecalls/kellogg01_09.html

Contact:
Kellogg Consumer Response Center
888-314-2060

FOR IMMEDIATE RELEASE -- Battle Creek, MI -- January 14, 2009 -- Kellogg Company today announced it has taken the precautionary measure of putting a hold on Austin® and Keebler® branded Toasted Peanut Butter Sandwich Crackers, Peanut Butter and Jelly Sandwich Crackers, Cheese and Peanut Butter Sandwich Crackers, and Peanut Butter-Chocolate Sandwich Crackers.

FDA and other regulatory agencies have indicated that Peanut Corporation of America (PCA) is the focus of their investigation concerning a recent Salmonella outbreak thought to be caused by tainted peanut butter. PCA is one of several peanut paste
suppliers that the company uses in its Austin® and Keebler® branded peanut butter sandwich crackers.

Kellogg Company's investigation has not indicated any concerns, nor has the Company received any consumer illness complaints about these products.

Nonetheless, Kellogg Company is taking precautionary measures including putting a hold on any inventory in its control, removing product from retail store shelves, and encouraging customers and consumers to hold and not eat these products until
regulatory officials complete their investigation of PCA and Kellogg provides further information as to the resolution of this issue.

"Consumer health and safety is our top priority," said David Mackay, president and CEO, Kellogg Company. "We are taking these voluntary actions out of an abundance of caution."

While no additional consumer action is necessary at this time, consumers with questions or who would like a product refund can call the Kellogg Consumer Response Center at 888-314-2060.

Wednesday, January 14, 2009

security lapse at SM Megamall

Security lapse at SM Megamall on January 14, 2009.
A security guard, at an entrance to said mall near the Bank of Philippine Islands office at said mall, didn't examine well what I had with me. As a result, I could have brought deadly weapons into said mall. I have receipts of goods I purchased on
said date from stores at said mall.

Advisory regarding ChowKing store at SM Megamall.
On January 14, 2009, there was a sign advertising Mango Tapioca. However, when my companion ordered said food. he was told said food was not available.

Advisory vs. National Book store branch at SM Megamall.
On January 14, 2009, the guard at the entrance to said store, didn't inspect my luggage and what I was using. As a result, I could have brought deadly weapons into said store. Also, an employee at said store didn't treat me well.

2008 Safety Alerts for Human Medical Products
(Drugs, Biologics, Medical Devices, Special Nutritionals, and Cosmetics)
http://www.fda.gov/medwatch/safety/2008/safety08.htm#Singulair


web sites with useful free information:

eatwell gov web site
http://www.eatwell.gov.uk/

National Fibromyalgia Association
http://www.fmaware.org/

Tuesday, January 13, 2009

Advisory re Creative Zen product,
After I downloaded update for said product, said product malfunctioned.

Candy and Childhood Lead Exposure
http://www.cdc.gov/nceh/lead/faq/candy.htm
The potential for children to be exposed to lead from candy imported from Mexico has prompted the U.S. Food and Drug Administration (FDA) to issue warnings on the availability of lead-contaminated candy and to develop tighter guidelines for
manufacturers, importers, and distributors of imported candy.

Lead has been found in some consumer candies imported from Mexico. Certain candy ingredients such as chili powder and tamarind may be a source of lead exposure. Lead sometimes gets into the candy when processes such as drying, storing, and grinding the ingredients are done improperly.Also, lead has been found in the wrappers of some imported candies. The ink of these plastic or paper wrappers may contain lead that leaches into the candy.

How to tell if your candy contains lead
You can tell for sure only by having the candy tested in a laboratory. If you have reason to suspect that you may have consumed lead in candy, see a healthcare provider for a blood test.

How to get more information about lead in candy
The FDA advises that parents, care providers, and others not allow children or pregnant women to eat candy imported from Mexico at this time. More information and advisories on lead in candy can be obtained from the FDA at www.fda.gov or
1-888-463-6332.



Lead in food and consumer products:
http://www.cdc.gov/nceh/lead/faq/FAQs.htm

*

NEW: Artificial Turf
*

Candy
*

Ceramicware (coming soon)
*

Folk Medicine
*

NEW: Sindoor Alert
*

Toy Jewelry
*

Toys



Last updated: 07/08/2008



Post Christmas Toy Safety Checklist
Some ideas about how to check your kid's toys for safety . . .

*All children's jewelry is highly suspect! Get rid of any jewelry that is not: sterling silver, ceramic beads, or gold.

Children have died from acute lead poisoning in cheap trinket jewelry

*Check healthytoys.org for the specific brand and toy type if it was made in China. Many well known brands (such as Melissa and Doug) have unsafe levels of lead and other toxins.

*If your girls received any children's makeup, check out the Environmental Working Group's Safe Cosmetic database. They've put together another great guide to safer cosmetics. Lisa at Enviroblogsums it up for busy, sleep deprived parents:

"Cosmetic ingredients to avoid:

DMDM hydantoin & Imidazolidinyl urea

Methylchloroisothiazolinone & Methylisothiazolinone

Fragrance and dyes

Parabens or -paraben

Triethanolamine

Iodopropynyl butylcarbamate

Triclosan & triclocarban



Cosmetic products to avoid:

Anti-aging creams with lactic, glycolic, AHA and BHA acids

Hair dyes with ammonia, peroxide, p-phenylenediamine, diaminobenzene, and all dark permanent hair dyes

Liquid hand soaps with Triclosan, aka Antibacterial hand soaps

Nail polish & removers with fermaldehyde

Skin lighteners with hydraquinone"


*Buy a lead test kit at your local hardware store if you can't find any information on healthtoys.org.


Tips to Prevent Lead Exposure
http://www.cdc.gov/nceh/lead/faq/tips.htm
Lead poisoning is entirely preventable. The key is stopping children from coming into contact with lead and treating

children who have been poisoned by lead.

The goal is to prevent lead exposure to children before they are harmed. There are many ways parents can reduce a child’s exposure to lead. The key is stopping children from coming into contact with lead. Lead hazards in a child’s environment
must be identified and controlled or removed safely.

Lead-based paint is the major source of exposure for lead in U.S. children. All houses built before 1978 are likely to contain some lead-based paint. However, it is the deterioration of this paint that causes a problem. You should determine
the construction year of the house or the dwelling where the child may spend a large amount of time (e.g., grandparents or daycare). In housing built before 1978, assume that the paint has lead unless tests show otherwise.

*

Talk to your state or local health department about testing paint and dust from your home for lead.

* Make sure your child does not have access to peeling paint or chewable surfaces painted with lead-based paint.

* Pregnant women and children should not be present in housing built before 1978 that is undergoing renovation. They should not participate in activities that disturb old paint or in cleaning up paint debris after work is completed.

* Create barriers between living/play areas and lead sources. Until environmental clean-up is completed, parents should clean and isolate all sources of lead. They should close and lock doors to keep children away from chipping or peeling paint
on walls. You can also apply temporary barriers such as contact paper or duct tape, to cover holes in walls or to block children’s access to other sources of lead.

*

Regularly wash children’s hands and toys. Hands and toys can become contaminated from household dust or exterior soil. Both are known lead sources.

*

Regularly wet-mop floors and wet-wipe window components. Because household dust is a major source of lead, parents should wet-mop floors and wet-wipe horizontal surfaces every 2-3 weeks. Windowsills and wells can contain high levels of
leaded dust. They should be kept clean. If feasible, windows should be shut to prevent abrasion of painted surfaces or opened from the top sash.

* Prevent children from playing in bare soil; if possible, provide them with sandboxes. Parents should plant grass on areas of bare soil or cover the soil with grass seed, mulch, or wood chips, if possible. Until the bare soil is covered,
parents should move play areas away from bare soil and away from the sides of the house. If using a sandbox, parents should also cover the box when not in use to prevent cats from using it as a litter box. That will help protect children from
exposure to animal waste.


To further reduce a child’s exposure from non-residential paint sources:

*

avoid using traditional home remedies and cosmetics that may contain lead;
*

avoid eating candies imported from Mexico;
*

avoid using containers, cookware, or tableware to store or cook foods or liquids that are not shown to be lead free;
*

remove recalled toys and toy jewelry immediately from children. Check Lead Recalls lists.
*

use only cold water from the tap for drinking, cooking, and for making baby formula (Hot water is more likely to

contain higher levels of lead. Most of the lead in household water usually comes from the plumbing in your house, not from

the local water supply.);
*

shower and change clothes after finishing a task that involves working with lead-based products such as stain glass work, bullet making, or using a firing range.



Last updated: 08/31/2007


Toy Jewelry and Childhood Lead Exposure
http://www.cdc.gov/nceh/lead/faq/jewelry.htm
If swallowed or put in the mouth, lead jewelry is hazardous to children. In 2003, a 4-year-old child swallowed a piece of jewelry bought from a vending machine. The child became ill because the jewelry was made of lead. The potential for children
to be exposed to lead from this source caused the U.S. Consumer Product Safety Commission (CPSC) to issue on July 8, 2004, a recall of 150 million pieces of metal toy jewelry sold widely in vending machines.

In 2006, there was a death of a child from acute lead poisoning after ingestion of a heart-shaped metallic charm containing lead. The charm had been attached to a metal bracelet provided as a free gift with the purchase of shoes manufactured by Reebok International Ltd. On March 23, 2006, a voluntary recall of 300,000 heart-shaped charm bracelets was announced by CPSC and Reebok.

What to do if I believe my child has put lead jewelry into his/her mouth
See your health care provider. He or she can perform a blood test to see whether your child has been exposed to lead and if so recommend treatment. Most children with elevated blood lead levels do not have any symptoms. However, there is no safe level of lead in blood. As blood lead levels increase, lead has a larger effect on children’s learning and behavior. A blood lead test is the only way you can tell if your child has an elevated lead level.

Effects of wearing toy jewelry
Just wearing toy jewelry will not cause your child to have a high level of lead in his/her blood. However, small children often put things in their mouth. If you have a small child in your household you should make sure the child does not
have access to jewelry or other items that may contain lead.

How to obtain more information about recalls
The CPSC asks that parents search their children’s toys for metal jewelry and throw it away. Photos of the jewelry and more information on the recall can be obtained from the visting the CPSC website or 1-800-638-2772. The CPSC also has a new
policy addressing lead in children's metal jewelry.

Monday, January 12, 2009

security lapse at Power Plant, Rockwell, Makati; about LG K500 phone; web sites with useful, free information

Security lapse at Power Plant mall at Rockwell, Makati
On January 12, 2009, deadly weapons could have been brought into said mall because security guard at entrance to said mall didn't inspect well my luggage, etc.

Public service advisory re LG K500 phone and "Eden Estopace"
who was identified as the source of allegations regarding the LG KP500 phone. Said allegations were published on page B-4 of the January 10, 2009 issue of the Philippine Star newspaper.The editor of said section wherein said allegations were
published was identified as Antonio R. Pano. Said allegations were:
(a) "The onscreen widgets for frequently used features . . . can . . . be
dragged around or changed as often as one would like to.
(b) the touch-screen phone is a good buy and promises a good user
experience."

If said phone cannot be dragged around or changed as often as customers who buy said phone would like to, will said Estopace compensate customers who buy said phone? If said phone does not turn out to be a good buy and does provide users with a good
experience, will said Estopace compensate people who buy said phone?


web sites with useful, free information:

Do It Yourself Network
http://www.diynetwork.com/

http://www.thegreenguide.com/

Mother Earth News web site
http://www.motherearthnews.com/

MotivationalQuotes4u web site
http://www.motivationalquotes4u.com/

information on evaluating the calorie content of foods and beverages.
http://www.cfsan.fda.gov/~ear/hwm/hwmintro.html

Saturday, January 10, 2009

advisory vs. Tokyo Tokyo restaurant; web sites with useful, free information:

advisory vs. Tokyo Tokyo restaurant
at Robinsons Place Ermita.
Said restaurant was identified as owned and operated by Long Life Noodle Co., Inc. On or about January 7, 2009, I ate at said store. I saw that one container for eating utensils was open and the utensils inside were exposed to dust, dirt, and insects.
Also, said container was not warm to the touch. As proof that I was at said store, I have a retail invoice bearing the name of said restaurant and numbered 12576 and dated 1/7/9. A copy of said invoice available.


web sites with useful, free information:

medicalnewstoday web site
http://www.medicalnewstoday.com/

nutritionlessons web site
http://nutritionlessons.com/

drsavard web site
http://www.drsavard.com/index.php

house-hold tips the funtimesguide web site
http://household-tips.thefuntimesguide.com/

extreme heat:
www.wwenglish.com/


Association for The Study of Obesity web site
http://www.aso.org.uk/portal.aspx

babiestoday web site
http://www.babiestoday.com/

bloglines web site
http://www.bloglines.com/

feeding bottles for babies:
http://www.babiestoday.com/

cosmopolitan web site
http://m.cosmopolitan.com/

dangers of drinking too much water:
sportsmedicine.about.com/
chemistry.about.com/
news.bbc.co.uk/
www.ravesafe.org/
www.boston.com/
nutrition.ucdavis.edu/
www.associatedcontent.com/
www.medicalnewstoday.com/
thatslifeinthecity.blogspot.com/
dailyrunningtips.com/
www.patriotfiles.com/
www.spirit-mind.co.uk/
www.dailymail.co.uk/
menwithpens.ca/
yedda.com/questions/
metabolic-disorders.suite101.com/
www.everybody.co.nz/


Office of Behavioral and Social Sciences Research Launches New Web Site
http://www.nih.gov/news/health/jan2009/od-08.htm

For Immediate Release
Thursday, January 8, 2009

Office of Behavioral and Social Sciences Research Launches New Web Site

A redesigned and enhanced Web site for scientists, advocacy groups, the media and the general public, providing key information on behavioral and social science research and activities at NIH, is now online at http://obssr.od.nih.gov.

The site, which features a new appearance, format and architecture, was launched by the Office of Behavioral and Social Sciences Research, in the Office of the Director at the National Institutes of Health.
The site contains more readily accessible and searchable information on funding opportunity announcements, key scientific areas, a calendar of news and events and video casts of the BSSR Lecture Series.

"The new Web site allows the office to communicate with researchers, advocacy groups, media, and the general public about critical research and training opportunities, lectures and news," said Acting Director Christine A. Bachrach, Ph.D. "Our new
site enhances our ability to communicate activities that support our mission of stimulating and coordinating behavioral and social science research across NIH."

In addition to a new look and feel, including a newly designed OBSSR logo, the Web site has improved navigation and has significant new content areas. Visitors can quickly navigate to the Office’s scientific areas of concentration:

Biopsychosocial Interactions; Genes, Behavior and Environment; Health and Behavior; Methodology; Social and Cultural Factors in Health; Translation.

Another addition is the From the Director column, which highlights critical issues and developments in the behavioral and social science fields.

The home page also highlights upcoming talks in the BSSR Lecture Series and news about the Office, such as the recent, first trans-NIH retreat for behavioral and social scientists.

The Office of Behavioral and Social Sciences Research (OBSSR) opened officially on July 1, 1995. The U.S. Congress established the Office of Behavioral and Social Sciences Research (OBSSR) in the Office of the Director, NIH, in recognition
of the key role that behavioral and social factors often play in illness and health. The OBSSR mission is to stimulate behavioral and social sciences research throughout NIH and to integrate these areas of research more fully into others of the NIH health research enterprise, thereby improving our understanding, treatment, and prevention of disease. For more information, please visit http://obssr.od.nih.gov.

The Office of the Director, the central office at NIH, is responsible for setting policy for NIH, which includes 27 institutes and centers. This involves planning, managing, and coordinating the programs and activities of all NIH components.

The Office of the Director also includes program offices which are responsible for stimulating specific areas of research throughout NIH. Additional information is available at http://www.nih.gov/icd/od.

The National Institutes of Health (NIH) — The Nation's Medical Research Agency — includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. It is the primary federal agency for conducting and supporting basic, clinical and translational medical research, and it investigates the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit www.nih.gov.


U.S. FDA 2008 Safety Alerts for Human Medical Products
(Drugs, Biologics, Medical Devices, Special Nutritionals, and Cosmetics)
http://www.fda.gov/medwatch/safety/2008/safety08.htm#Ezetimibe


U.S. FDA Jan 9_2009 New and Generic Drug Approvals
# New and Generic Drug Approvals

* Alfuzosin Hydrochloride Extended-Release Tablets, TEVA Pharmaceuticals USA, Tentative Approval
* Tri-Nasal (triamcinolone acetonide) Nasal Spray, Collegium Pharmaceutical, Control Supplement
* Ciclopirox Gel, Paddock Laboratories, Inc., Approval
* Genotropin (somatropin recombinant) Injection, Pharmacia & Upjohn Co., Control Supplement
* Nicardipine Hydrochloride Injection, Teva Parenteral Medicines, Labeling Revision
* Stavudine Capsules, Matrix Laboratories, Ltd., Approval
* Vytorin (ezetimibe and simvastatin) Tablets, MSP Singapore Company, LLC, Labeling Revision

Thursday, January 8, 2009

Are Emergency Departments of Philippine hospitals designed, managed, and supported in ways that ensure patient safety?

* Are there sufficient spaces for the delivery of care?
* Did the number of patients exceed ED capacity to provide safe care?
* How long after being contacted did specialty consultation for critically ill
patients arrive?
* How long did it take ED patients requiring admission to the ICU to
be transferred from the ED to the ICU?
* How many, if any, of the people in the ED, have been trained in emergency
medicine?

advisory regarding Ching M. Alano concerning BPA-free feeding bottles
The following allegations were published in what was identified as said Alano's column in the January 6, 2008 issue of the Philippine Star newspaper:

". . . you can purchase BPA-free feeding bottles (4 or 8 oz.)
at SM branches."

What is the basis, if any, for the allegation that said bottles are BPA-free?

Hospira Issues Voluntary Recall
of One Lot of 20meq Potassium Chloride in 5% Dextrose and 0.45% Sodium Chloride Injection, USP Due to Incorrect Bar Code Label
http://www.fda.gov/oc/po/firmrecalls/hospira12_08.html
FOR IMMEDIATE RELEASE -- LAKE FOREST, Ill., Dec. 8, 2008 -- Hospira, Inc., a global specialty pharmaceutical and medication delivery company, is following up on a . . . voluntary recall issued Sept. 18 of one lot (lot number 65-620-FW, expiration date May 1, 2010, NDC 0409-7902-09) of 20 mEq Potassium Chloride in 5% Dextrose and 0.45% Sodium Chloride Injection, USP in 1000 mL flexible plastic containers because a small number of the containers may be incorrectly labeled with a bar code for 5% Dextrose Injection, USP (NDC 0409-7922-09). The incorrect bar code could lead to a medication error resulting in the wrong drug being delivered to a patient if a bar code system is used to confirm the medication. Potential adverse events related to an error of this type include electrolyte imbalance, cardiac dysfunction, gastrointestinal disturbances, paresthesia and mental confusion.


New Report Recommends Strategies To Reduce Medical Resident Fatigue-related Errors and Improve Training
http://www.ahrq.gov/news/press/pr2008/iomrespr.htm


Press Release Date: December 2, 2008

Fatigued medical residents need protected sleep periods and increased supervision of work hour limits to improve patient safety and the training environment, according to a new Institute of Medicine (IOM) report funded by the Department of Health & Human Services' (HHS) Agency for Healthcare Research and Quality (AHRQ).

The study confirms that scientific evidence shows acute and chronically fatigued residents are more likely to make mistakes.

The IOM committee recommends several changes to the existing 80-hour-per-week limit on work hours, including protected sleep periods for residents. The IOM recommends a change to require residents who complete a 30-hour shift to only treat patients for up to 16 hours. They must then have a five-hour protected sleep period between 10 p.m. and 8 a.m., during which time other non-sleeping residents or additional staff members could take over patient care.

"The Institute of Medicine study provides the clear evidence to prove what we have long-believed is true—fatigue increases the chance for human error," said AHRQ Director Carolyn M. Clancy, M.D. "Most importantly, this report provides solid recommendations that can improve patient safety, as well as increase the quality of the resident training experience."

Other recommendations in the report, Resident Duty Hours: Enhancing Sleep, Supervision, and Safety, include:

* Increased supervision of work hours. Lack of adherence to limits is common and often underreported. The IOM report recommends periodic independent reviews and strengthened protections for residents and others who report a lack of adherence to current work hour restrictions.
* Stronger moonlighting restrictions. Current ACGME rules only count internal moonlighting (additional paid health care work at same health care facility) against the 80-hour weekly limit. The IOM report recommends internal and external moonlighting count against the 80-hour weekly limit, because moonlighting outside residency training affects strategically designed periods for rest and sleep, which could reduce residents' readiness for their primary duties.
* Guaranteed days off to permit adequate recovery after working long shifts. The IOM committee said residents should receive a 24-hour break from duty each week, with one 48-hour break per month, for a total of five days off per month.
* Reasonable on-call periods. The IOM committee said residents should be on call in the hospital no more than every third night.
* Safe transportation provided by hospitals to residents who are too fatigued to drive home. AHRQ-funded research shows that residents more than double their risk of driving accidents when they drive home after working extended shifts.
* Increased resident training on better communication during handovers. Handovers, when clinicians transition care responsibility to other health care providers, are likely to increase with shorter resident shifts. In some cases, multiple handovers could add to the risk for adverse events unless a structured team approach is used.
* Increased involvement of residents in patient safety activities and adverse event reporting.



Questions to ask local hospitals:

Does said hospital have a centralized system for collecting reports of adverse events? reporting system?
Does said hospital fully distribute adverse event summary reports?
Does said hospital encourage reporting by a range of hospital staff, and distribute timely summary reports that are reviewed by senior-level staff?
Are said reports used to develop event reduction strategies.
Has said hospital established “supportive environments” that allow anonymous reporting.
Does said hospital have broad staff involvement in reporting adverse events?

FDA Drug Approval Reports
http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Reports.ReportsMenu

FDA Radiological Health Program
http://www.fda.gov/cdrh/radhealth/

Radiation-Emitting Products
Subscribe to Email Updates Subscribe
Products and Procedures

* A-Z List
* Medical Imaging
X-Rays, CT (Computed Tomography), Fluoroscopy, Mammography...
* Other Medical & Surgical Products
Surgical Lasers, Ultrasound Therapy...
* Consumer & Business Products
Cell Phones, Laser Light Shows...

Radiation Dose Reduction

* Reducing Radiation Risk from Computed Tomography for Pediatric and Small Adult Patients
* Focusing in on Dose Reduction: The FDA Perspective
* New England Journal of Medicine (NEJM) Article, "Computed Tomography (CT) - An Increasing Source of Radiation Exposure"
* American College of Radiology Appropriateness Criteria®

News & Highlights

* Electronic Submission of Diagnostic X-ray Reports of Assembly (January 6, 2009)
* CeSub Electronic Submissions Software Updated (January 5, 2009)
* Available in CeSub: Microwave Oven Radiation Safety (Product) Report, Television Radiation Safety (Product) Report (September 5, 2008)


Regulated Industry

* Getting Your Product to Market (FAQs)
* Products Subject to Performance Standards
* Laws, Regulations and Performance Standards
* Radiation-Emitting Electronic Product Codes
* Reports and Recordkeeping
* CeSub Electronic Submission Program
* Industry Guidance
* Imports & Exports

Radiation Safety

* Report a Problem
* Electromagnetic Compatibility (EMC)
* Nationwide Evaluation of X-Ray Trends (NEXT)

FDA's Role in Radiation Protection

* Radiological Health Program
o New Directions
o Questions and Answers
* Mammography Program

Other Resources

Updated January 7, 2009


Department of Trade and Industry received warning letter
regarding Sun Cellular Shop

The Department of Trade and Industry - National Capital Region received warning letter regarding Sun Cellular Shop. Evidence is a letter bearing what was identified as bearing the the letterhead of the Department of Trade and Industry Legal Affairs Center and titled "1st Indorsement December 23, 2008 and addressed to the Shop Manager, Sun Cellular Shop, Robinsons Place Ermita. Said letter contained the following words:

"Respectfully forwarded to THE SHOP MANAGER,
Sun Cellular Shop, Robinsons Place Ermita . . . the
herein attached warning-letter of . . . M. Silva . . .
as the subject matter is within your area of concern."

Said letter bore the name "Asst. Sec. MA THERESA "Angel" L. Pelayo-Ty
National Capital Region/Regional Operations Group".

Tuesday, January 6, 2009

web sites with information on storing holiday decorations

Fire Safety Deficiencies

Based on information from an article titled "BFP chief leads fire safety checks in malls, stores" which was published on page 2 of the Manila Bulletin newspaper issue of Thursday November 27, 2008, the following deficiencies were noted during the
inspection conducted at the Gotesco Grand Central last Nov. 25 (2008).

* Inappropriate directional signs and exit signs were not battery operated and not luminous;
* Some emergency lights are defective - fire exits do not lead to safe open spaces or public roads;
* LPG tanks of food chains operating inside the malls are stored inside the building;
* Stairs landing obstructed . . .;

On the other hand, the following violations were noted at the department store:

* Fire exit door . . . does not swing in the direction of exit;
* Exit door is not panic hardware door;
* No emergency lights at means of egress and stairway leading to exit;

Based on said statements,
* exit signs must be battery operated and luminous;
* fire exits must lead to safe open spaces or public roads;
* LPG tanks of food chains operating inside the malls must be stored outside the building;
* stairs landing must not be obstructed;
* Fire exit door must swing in the direction of exit;
* Exit door must be panic hardware door;

Check out the following web sites:

zamzar web site:
http://www.zamzar.com

computeruser web site
http://www.computeruser.com/

handyfact web site
http://www.handyfact.com/

Prehistoric Time Line
http://science.nationalgeographic.com/science/prehistoric-world/prehistoric-time-line.html

web sites with information on storing holiday decorations:

interiordec.about.com/

www.realsimple.com/

www.rd.com/

www.bhg.com/home-improvement/

shine.yahoo.com/

www.myfoxstl.com/

organizedchristmas.com/

www.essortment.com/

www.associatedcontent.com/

realtytimes.com/rtpages/

Friday, January 2, 2009

Mass Casualty Event Preparedness and Response information; etc.

web site with useful, free information:
Bartleby Reference
Bartleby.com



Tips for people who eat out
http://www.consumeraffairs.iocom/news04/2007/10/healthy_restaurants.html


Tips for users of notebook computers
http://www.pcworld.com/article/156028/article.html?tk=nl_mcxblg

Mass Casualty Event Preparedness and Response
http://emergency.cdc.gov/masscasualties/

Info for the General Public
Preparing for a Terrorist Bombing: A Common Sense Approach

Although terrorists use a variety of methods to inflict harm and create fear, bombs are used most frequently. According to the U. S. Federal Bureau of Investigation, bombings accounted for nearly 70 percent of all terrorist attacks in the U.S. and its territories between 1980 and 20011. This document focuses on common sense principles that will be useful in a bombing event.

What can I do now?

CDC and the American Red Cross encourage every organization, family and individual to take time to prepare for an emergency or disaster. These steps can help you get started:

* Know your work, school and community disaster plans. If you are not familiar with the plans, contact your supervisor, school administrators, or your local fire department for information.
* Identify an alternative hospital. Hospitals closest to the event are always the busiest.
* Visit http://www.redcross.org/preparedness. The site provides guidance on creating a disaster plan and steps you can take now to protect yourself and your loved ones.

What should I do if I think someone is going to set off a bomb?
At Home At Work At School In Public
Leave the area immediately. Follow existing evacuation guidelines.
Call 9-1-1. Tell the operator what you saw or know (suspicious persons, packages, or vehicles). Call 9-1-1. Tell the operator what you saw or know (suspicious persons, packages, or vehicles).
Follow directions from people in authority (police, fire, EMS, or military personnel, or from workplace supervisors. or from school administrators, or from commumity leaders).

What should I do during a terrorist bombing?

If you are in a bombing event:

* Leave the area immediately.
* Avoid crowds. Crowds of people may be targeted for a second attack.
* Avoid unattended cars and trucks. Unattended cars and trucks may contain explosives.
* Stay away from damaged buildings to avoid falling glass and bricks. Move at least 10 blocks or 200 yards away from damaged buildings.
* Follow directions from people in authority (police, fire, EMS, or military personnel, or from school or workplace supervisors).
* Call 9-1-1 once you are in a safe area, but only if police, fire, or EMS has not arrived.
* Help others who are hurt or need assistance to leave the area if you are able. If you see someone who is seriously injured, seek help. Do not try to manage the situation alone.

What should I do after the bombing?

When the explosion is over:

* Follow your family, job, or school emergency disaster plan for leaving and staying away from the scene of the event. Remember, returning to the scene will increase the risk of danger for rescue workers and you.
* Avoid crowds. Crowds of people may be targeted for a second attack.
* Avoid unattended cars and trucks. Unattended cars and trucks may contain explosives.
* Stay away from damaged buildings to avoid falling glass and bricks. Move at least 10 blocks or 200 yards away from damaged buildings.
* Follow directions from people in authority (police, fire, EMS, or military personnel, or from school or workplace supervisors).
* Call 9-1-1 once you are in a safe area, but only if police, fire, or EMS has not arrived to help injured people.
* Help others who are hurt or need assistance to leave the area if you are able. If you see someone who is seriously injured, seek help. Do not try to manage the situation alone.
* Listen to your radio or television for news and instructions.

What if rescue workers are not available to transport me or other injured persons?

9-1-1 services (police, fire, EMS and ambulance) might be delayed indefinitely following a terrorist event, therefore:

* Always have a back-up plan for transportation.
* Follow advice from your local public safety offices (local health department, local emergency management offices, fire and police departments and reliable news sources).

When should I go to the hospital or clinic?

Seek medical attention if you have any of the following problems:

* Excessive bleeding
* Trouble breathing
* Persistent cough
* Trouble walking or using an arm or leg
* Stomach, back or chest pains
* Headache
* Blurred vision or burning eyes
* Dry mouth
* Vomiting or diarrhea
* Rash or burning skin
* Hearing problems
* Injuries that increase in pain, redness or swelling
* Injuries that do not improve after 24 to 48 hours

Help others who are hurt or need assistance to leave the area, if you are able.If you see someone who is seriously injured, seek help. Do not try to manage the situation alone.
Where should I go for care?

Go to a hospital or clinic away from the event if you can. Most victims will go to the nearest hospital. Hospitals away from the event will be less busy.
What can I expect at the hospital?

* Long waits. To avoid long waits, choose a hospital farther away from the event. While this might increase your travel time, you might receive care sooner.
* Triage. Following a terrorist attack or other disasters, injuries are generally treated on a “worst first” basis, called “triage.” Triage is not “first come, first served”. If your injuries are not immediately life threatening, others might be treated before you. The goal of triage is to save as many lives as possible.
* Limited information. In a large-scale emergency such as a terrorist attack, police, fire, EMS, and even hospitals and clinics cannot track every individual by name. Keep in mind that it may be difficult for hospitals to provide information about loved ones following a terrorist attack. Be patient as you seek information.

For more information about how to prepare for a terrorist bombing and other disasters, click on the related links:

* American Red Cross, “Terrorism—Preparing for the Unexpected.” http://www.redcross.org/services/disaster/0,1082,0_589_,00.html.
* Federal Emergency Management Agency (FEMA), http://www.fema.gov.

* Mass casualties and injuries from terrorism, CDC’s Emergency Preparedness and Response Website. http://emergency.cdc.gov.

* United States Department of Homeland Security, http://www.ready.gov.

1. U.S. Department of Justice, Federal Bureau of Investigation, Terrorism 1980-2001. www.fbi.gov/publications/terror/terror2000_2001.htm



Coping With a Traumatic Event:

Information for the Public (see also Information for Health Professionals)
HIGHLIGHTS

* Traumatic events often cause feelings of fear, grief and depression.
* There are many things you can do to cope with traumatic events, including talking to family, friends, and clergy for support.
* Let your child know that it is okay to feel upset when something bad or scary happens.
* You may need to consider seeking professional help if your feelings affect your relationship with your family and friends, or affect your job.

What Is a Traumatic Event?

Most everyone has been through a stressful event in his or her life. When the event, or series of events, causes a lot of stress, it is called a traumatic event. Traumatic events are marked by a sense of horror, helplessness, serious injury, or the threat of serious injury or death. Traumatic events affect survivors, rescue workers, and the friends and relatives of victims who have been involved. They may also have an impact on people who have seen the event either firsthand or on television.
What Are Some Common Responses?

A person’s response to a traumatic event may vary. Responses include feelings of fear, grief and depression. Physical and behavioral responses include nausea, dizziness, and changes in appetite and sleep pattern as well as withdrawal from daily activities. Responses to trauma can last for weeks to months before people start to feel normal again.

Most people report feeling better within three months after a traumatic event. If the problems become worse or last longer than one month after the event, the person may be suffering from post-traumatic stress disorder (PTSD).
What Is PTSD?

Post-traumatic stress disorder (PTSD) is an intense physical and emotional response to thoughts and reminders of the event that last for many weeks or months after the traumatic event. The symptoms of PTSD fall into three broad types: re-living, avoidance and increased arousal.

* Symptoms of re-living include flashbacks, nightmares, and extreme emotional and physical reactions to reminders of the event. Emotional reactions can include feeling guilty, extreme fear of harm, and numbing of emotions. Physical reactions can include uncontrollable shaking, chills or heart palpitations, and tension headaches.

* Symptoms of avoidance include staying away from activities, places, thoughts, or feelings related to the trauma or feeling detached or estranged from others.

* Symptoms of increased arousal include being overly alert or easily startled, difficulty sleeping, irritability or outbursts of anger, and lack of concentration.

Other symptoms linked with PTSD include: panic attacks, depression, suicidal thought and feelings, drug abuse, feelings of being estranged and isolated, and not being able to complete daily tasks.
What Can You Do for Yourself?

There are many things you can do to cope with traumatic events.

* Understand that your symptoms may be normal, especially right after the trauma.

* Keep to your usual routine.

* Take the time to resolve day-to-day conflicts so they do not add to your stress.

* Do not shy away from situations, people and places that remind you of the trauma.

* Find ways to relax and be kind to yourself.

* Turn to family, friends, and clergy person for support, and talk about your experiences and feelings with them.

* Participate in leisure and recreational activities.

* Recognize that you cannot control everything.

* Recognize the need for trained help, and call a local mental health center.

What Can You Do for Your Child?

* Let your child know that it is okay to feel upset when something bad or scary happens.

* Encourage your child to express feelings and thoughts, without making judgments.

* Return to daily routines.

When Should You Contact Your Doctor or Mental Health Professional?

About half of those with PTSD recover within three months without treatment. Sometimes symptoms do not go away on their own or they last for more than three months. This may happen because of the severity of the event, direct exposure to the traumatic event, seriousness of the threat to life, the number of times an event happened, a history of past trauma, and psychological problems before the event.

You may need to consider seeking professional help if your symptoms affect your relationship with your family and friends, or affect your job. If you suspect that you or someone you know has PTSD, talk with a health care provider or call your local mental health clinic.


Emergency Wound Care After a Natural Disaster

(NOTE: Health professionals should see Emergency Wound Management for Healthcare Professionals.)

The risk for injury during and after a hurricane and other natural disasters is high. Prompt first aid can help heal small wounds and prevent infection. Tetanus is a potential health threat for persons who have open wounds.

Seek medical attention as soon as possible if:

* There is a foreign object embedded in the wound;

* The wound is at special risk of infection (such as a dog bite or a puncture by a dirty object);

* An old wound shows signs of becoming infected (increased pain and soreness, swelling, redness, draining, or you develop a fever).

How to Care for Minor Wounds

* Wash your hands thoroughly with soap and clean water if possible.
* Avoid touching the wound with your fingers while treating it (if possible, use disposable, latex gloves).
* Remove obstructive jewelry and clothing from the injured body part.
* Apply direct pressure to any bleeding wound to control bleeding.
* Clean the wound after bleeding has stopped.
o Examine wounds for dirt and foreign objects.
o Gently flood the wound with bottled water or clean running water (if available, saline solution is preferred).
o Gently clean around the wound with soap and clean water.
o Pat dry and apply an adhesive bandage or dry clean cloth.
* Leave unclean wounds, bites, and punctures open. Wounds that are not cleaned correctly can trap bacteria and result in infection.
* Provide pain relievers when possible.

Other Considerations

* Expect a variety of infection types from wounds exposed to standing water, sea life, and ocean water.
* Wounds in contact with soil and sand can become infected.
* Puncture wounds can carry bits of clothing and dirt into wounds and result in infection.
* Crush injuries are more likely to become infected than wounds from cuts.
* Take steps to prevent tetanus

If you have wounds, you should be evaluated for a tetanus immunization. If you receive a puncture wound or a wound contaminated with feces, soil, or saliva, have a health care professional determine whether a tetanus booster is necessary based on individual records.
References

Krohmer, J.R., Rapp M.T. & American College of Emergency Physicians.(2001). First aid manual: A comprehensive guide to treating emergency victims of all ages in any situation. (3 rd ed.) New York : Dorling Kindersley Limited.

Tintinalli, J.E., Kelen, G.D., Stapczynski, J.S., & American College of Emergency Physicians. (2004). Emergency medicine: A comprehensive guide. (6th ed.) New York : McGraw-Hill.


Injuries and Mass Casualty Events:

Information for the Public (see also Information for Health Professionals)

If you are injured or think you are injured, seek medical attention right away. Injuries that occur during a mass casualty event are at high risk for infection and other long lasting health effects.
What Injuries Occur Most Often?

The most severe injuries in mass casualty events are fractures, burns, lacerations, and crush injuries. However, the most common injuries are eye injuries, sprains, strains, minor wounds, and ear damage.
Why Do These Injuries Occur in Mass Casualty Events?

* Eye injuries and irritation can occur from excess particles (such as soot, dirt, powder, paint chips), fumes or smoke present in the air after a disaster event. More serious eye problems can result from metal or glass fragments that enter the eye at a high speed.

* Sprains and strains are common in these situations and can occur as people escape the scene, fall, are thrown or pushed down by a force, or carry others who are in need of assistance.

* Minor wounds can be caused by flying debris and falling on or scraping against sharp objects.

* Eardrum damage can occur from a foreign body entering the ear, a blow or jolt to the head, or an extreme and sudden noise (i.e. explosion) all of which are likely in a mass casualty event.

How Do Mass Casualty Events Affect My Health?

It is normal for people to suffer emotional and physical stress after a mass casualty event, even if they are not at or near the scene. This additional stress can make existing health conditions worse (for example, diabetes) or trigger a new health problem (for example, heart attack, depression). If a mass casualty event occurs, try to take care of yourself by:

* Maintaining healthy eating, exercise, and sleeping habits;

* Continuing to take your medicine as prescribed by your physician;

* Keeping with your daily routine;

* Talking to people about your feelings and concerns.

What Should I Do If I Have a Health Problem?

Seek medical attention immediately. It is important to see a doctor for injuries and other health problems that arise or worsen after a mass casualty event. Proper medical attention can help prevent complications and long-lasting health effects.

Listen to your local news to identify which hospitals or clinics are open. In mass casualty events, certain hospitals may be closed or only open to certain kinds of patients. However, many other hospitals and clinics, especially those outside the immediate area of the event, will be available to see patients with injuries and other health problems. If you are having a health problem, seek medical care. Do not delay because of a mass casualty event.
For More Information

* Visit the website of your state health department.

* Visit the website of CDC's Injury Center for injury information and resources.


Brain Injuries and Mass Casualty Events:

Information for the Public (see also Information for Clinicians)

Traumatic brain injuries can occur during mass casualty events. If you think you or someone you know has a brain injury, contact your health care provider.
What is a traumatic Brain Injury?

A traumatic brain injury (TBI) is defined as a blow or jolt to the head or a penetrating head injury that disrupts the normal function of the brain.. Not all blows or jolts to the head result in a TBI. The severity of such an injury may range from “mild,” that is, a brief change in mental status or consciousness to “severe,” that is, an extended period of unconsciousness or amnesia after the injury. A TBI can result in short or long-term problems with an individual’s ability to function independently, or changes that affect thinking, memory, sensation, language, and emotions.
Why Are TBIs a Problem in Mass Casualty Events?

In mass casualty events, such as the World Trade Center attack or the Oklahoma City bombing, TBIs were caused by flying debris or by a person falling and hitting their head. A blast from an explosion can also cause a TBI even when there is no direct contact with an object.
What Are Some Common Signs and Symptoms of a TBI?

The signs and symptoms of a TBI can be subtle. Symptoms of a TBI may not appear until days or weeks following the injury or may even be missed as people may look fine even though they may act or feel differently. The following are some common signs and symptoms of a TBI:

* Headaches or neck pain that do not go away;
* Difficulty remembering, concentrating, or making decisions;
* Slowness in thinking, speaking, acting, or reading;
* Getting lost or easily confused;
* Feeling tired all of the time, having no energy or motivation;
* Mood changes (feeling sad or angry for no reason);
* Changes in sleep patterns (sleeping a lot more or having a hard time sleeping);
* Light-headedness, dizziness, or loss of balance;
* Urge to vomit (nausea);
* Increased sensitivity to lights, sounds, or distractions;
* Blurred vision or eyes that tire easily;
* Loss of sense of smell or taste; and
* Ringing in the ears.

What Can You Do to Get Help?

If you think you or someone you know has a TBI, contact your health care provider. Your health care provider can refer you to a neurologist, neuropsychologist, neurosurgeon, or specialist in rehabilitation (such as a speech pathologist). Getting help soon after the injury by trained specialists may speed your recovery.
For More Information, Contact:
The Brain Injury Association of America (BIAA)

* Call the toll-free help line at 1-800-444-6443 for help in English or Spanish
* Visit the website at www.biausa.org

The Defense and Veterans Brain Injury Center (DVBIC)

* Call Toll Free for information 1-800-870-9244
* Visit the website at www.dvbic.org

The Centers for Disease Control and Prevention (CDC)

* Learn about CDC’s TBI-related activities and products online at: http://www.cdc.gov/node.do?id=0900f3ec8000dbdc.
* Download a free copy of CDC’s “ Facts about traumatic Brain Injury” fact sheet.
* Download or order the free brochure, Facts about Concussion and Brain Injury, (in English and Spanish) online at: www.cdc.gov/ncipc/tbi/default.htm.


Mass Casualties: Burns

Mass casualties and disasters such as explosions and fires can cause a variety of serious injuries, including burns. These can include thermal burns, which are caused by contact with flames, hot liquids, hot surfaces, and other sources of high heat as well as chemical burns and electrical burns. It is vital that people understand how to behave safely in mass casualty and fire situations, as well as comprehend basic principles of first aid for burn victims. For burns, immediate care can be lifesaving.

Note: Most victims of fires die from smoke or toxic gases, not from burns (Hall 2001). This guideline covers burn injuries.
Background Information

* On average in the United States in 2004, someone died in a fire every 135 minutes, and someone was injured every 30 minutes (Karter 2005).

* Each year in the United States, 1.1 million burn injuries require medical attention (American Burn Association, 2002).
o Approximately 50,000 burn injuries require hospitalization;
o Approximately 20,000 are major burns involving at least 25 percent of the total body surface;
o Approximately 4,500 of these people die.

* Up to 10,000 people in the United States die every year of burn-related infections.

* Only 60 percent of Americans have an escape plan, and of those, only 25 percent have practiced it (NFPA, 1999).

* Smoke alarms cut your chances of dying in a fire in half (NFPA, 1999).

Escape Information
Safeguard Your Home

* Install smoke alarms on each floor of your home. One alarm must be outside a bedroom where you sleep.
* Change batteries in smoke alarms at least once a year. (Never borrow smoke alarm batteries for other purposes).
* Keep emergency phone numbers and other pertinent information posted close to your telephone.
* Draw a floor plan and find two exits from each room. Windows can serve as emergency exits.
* Practice getting out of the house through the various exits.
* Designate a meeting place at a safe distance outside the home.
* Respond to every alarm as if it were a real fire.
* Call the fire department after escaping. Tell them your address and do not hang up until you are told to do so. Let them know if anyone is trapped inside.
* Never go back into a burning building to look for missing people, pets, property, etc. Wait for firefighters.

Hotel and Workplace Fire Safety

* Become familiar with exits and posted evacuation plans each time you enter a building.
* Learn the location of all building exits. You may have to find your way out in the dark.
* Ensure that fire exits are unlocked and clear of debris.
* All buildings, whether homes, workplaces or hotels, should have working smoke alarm systems. Make sure you know what the alarm sounds like.
* Respond to every alarm as if it were a real fire. If you hear an alarm, leave immediately and close doors behind you as you go.
* Establish an outside meeting place where everyone can meet after they have escaped.
* Call the fire department after escaping. Tell them your address and do not hang up until you are told to do so. Let them know if anyone is trapped inside.
* Never go back into a burning building to look for missing people, pets, property, etc. Wait for firefighters.

If You Are Trapped in a Burning Building

* Smoke rises, so crawl low to the ground where the air will be cleanest.
* Get out quickly if it is safe to leave. Cover your nose and mouth with a cloth (moist if possible).
* Test doorknobs and spaces around doors with the back of your hand. If the door is warm, try another escape route. If it is cool, open it slowly. Check to make sure your escape path is clear of fire and smoke.
* Use the stairs. Never use an elevator during a fire.
* Call the fire department for assistance if you are trapped. If you cannot get to a phone, yell for help out the window. Wave or hang a sheet or other large object to attract attention.
* Close as many doors as possible between yourself and the fire. Seal all doors and vents between you and the fire with rags, towels, or sheets. Open windows slightly at the top and bottom, but close them if smoke comes in.

First Aid

What you do to treat a burn in the first few minutes after it occurs can make a huge difference in the severity of the injury.
Immediate Treatment for Burn Victims

1. “Stop, Drop, and Roll” to smother flames.
2. Remove all burned clothing. If clothing adheres to the skin, cut or tear around burned area.
3. Remove all jewelry, belts, tight clothing, etc., from over the burned areas and from around the victim’s neck. This is very important; burned areas swell immediately.

Types of Burns
First-Degree Burns

First-degree burns involve the top layer of skin. Sunburn is a first-degree burn.

Signs:

* Red
* Painful to touch
* Skin will show mild swelling

Treatment:

* Apply cool, wet compresses, or immerse in cool, fresh water. Continue until pain subsides.
* Cover the burn with a sterile, non-adhesive bandage or clean cloth.
* Do not apply ointments or butter to burn; these may cause infection.
* Over-the-counter pain medications may be used to help relieve pain and reduce inflammation.
* First degree burns usually heal without further treatment. However, if a first-degree burn covers a large area of the body, or the victim is an infant or elderly, seek emergency medical attention.

Second-Degree Burns

Second-degree burns involve the first two layers of skin.

Signs:

* Deep reddening of the skin
* Pain
* Blisters
* Glossy appearance from leaking fluid
* Possible loss of some skin

Treatment:

* Immerse in fresh, cool water, or apply cool compresses. Continue for 10 to 15 minutes.
* Dry with clean cloth and cover with sterile gauze.
* Do not break blisters.
* Do not apply ointments or butter to burns; these may cause infection
* Elevate burned arms or legs.
* Take steps to prevent shock: lay the victim flat, elevate the feet about 12 inches, and cover the victim with a coat or blanket. Do not place the victim in the shock position if a head, neck, back, or leg injury is suspected, or if it makes the victim uncomfortable.
* Further medical treatment is required. Do not attempt to treat serious burns unless you are a trained health professional.

Third-Degree Burns

A third-degree burn penetrates the entire thickness of the skin and permanently destroys tissue.

Signs:

* Loss of skin layers
* Often painless. (Pain may be caused by patches of first- and second-degree burns which often surround third-degree burns).
* Skin is dry and leathery
* Skin may appear charred or have patches which appear white, brown or black

Treatment:

* Cover burn lightly with sterile gauze or clean cloth. (Do not use material that can leave lint on the burn).
* Do not apply ointments or butter to burns; these may cause infection
* Take steps to prevent shock: lay the victim flat, elevate the feet about 12 inches.
* Have person sit up if face is burned. Watch closely for possible breathing problems.
* Elevate burned area higher than the victim’s head when possible. Keep person warm and comfortable, and watch for signs of shock.
* Do not place a pillow under the victim’s head if the person is lying down and there is an airway burn. This can close the airway.
* Immediate medical attention is required. Do not attempt to treat serious burns unless you are a trained health professional.

References

Ahrens M. (2001) The U.S. fire problem overview report: Leading causes and other patterns and trends. Quincy (MA): National Fire Protection Association.

American Burn Associations (2002). Burn Incidence Fact Sheet.

Burn Foundation (2002) Travel Safe Guide - Surviving a Hotel Fire.

CDC, National Center for Health Statistics (NCHS). (1998) National vital statistics system. Hyattsville (MD): U.S. Department of Health and Human Services, CDC, National Center for Health Statistics.

Gibran NS, Heimbach DM. (2000) Current status of burn wound pathophysiology. Clinical Plastic Surgery; 27 (1): 11-22.

Gueugniaud PY, et al. (2000) Current advances in the initial management of major thermal burns. Intensive Care Med; 26 (7): 848-56.

Hall JR. (2001) Burns, toxic gases, and other hazards associated with fires: Deaths and injuries in fire and non-fire situations. Quincy (MA): National Fire Protection Association, Fire Analysis and Research Division.

Hilton G. (2001) Emergency. Thermal burns. AJ7N, American Journal of Nursing. 101(11):32-4.

Istre GR, McCoy MA, Osbom L, Bamard JJ, Bolton A. (2001) Deaths and injuries from house fires. New England Journal of Medicine; 344:1911—16.

Karter MJ. (2005) Fire loss in the United States during 2004. Quincy (MA): National Fire Protection Association, Fire Analysis and Research Division.

National Fire Protection Association (1999) NFPA National Fire Escape Survey, Quincy (MA).

Parker DJ, Sklar DP, Tandberg D, Hauswald M, Zumwalt RE. (1993) Fire fatalities among New Mexico children. Annals of Emergency Medicine; 22(3):5 17—22.

Yowler CJ, Fratianne RB. (2000) Current status of burn resuscitation. Clinical Plastic Surgery; 27 (1): 1-10.





Information from U.S.FDA regarding INNOHEP

[PDF] IMPORTANT INNOHEP (tinzaparin sodium injection) SAFETY INFORMATION ...
Page 1. Celgene Corporation 86 Morris Avenue Summit, New Jersey 07901 Tel
908-673-9000 Fax 908-673-9001 IMPORTANT INNOHEP ® (tinzaparin ...
www.fda.gov/medwatch/safety/2008/Celgene_Innohep_DHCP_Letter.pdf - 12-31-2008 - Text Version


www.fda.gov/cder/whatsnew.htm - 12-31-2008 - Cached
Faulty Instructions Prompt Recall of Electrical Wiring How-to-Books by The Taunton Press; Shock Hazard to Consumers
http://www.cpsc.gov/cpscpub/prerel/prhtml09/09078.html

Thursday, January 1, 2009

66 WAYS TO SAVE MONEY: Etc.

66 WAYS TO SAVE MONEY
http://www.pueblo.gsa.gov/cic_text/money/66ways/content#major

Popular New Year's Resolutions with links to sources of useful information on how to achieve said resolutions:
http://www.usa.gov/Citizen/Topics/New_Years_Resolutions.shtml


Warnings and Safety Information regarding Dietary Supplements
http://www.cfsan.fda.gov/~dms/ds-warn.html

Alerts

* Androstenedione
o see Androstenedione March 11, 2004
* Anthrax
o Dietary Supplements Claiming to Prevent or Treat Anthrax November 7, 2001
o FTC Cracks down on Marketers of Bogus Bioterrorism Defense Products November 19, 2001
* Aristolochic Acid
o FDA Concerned About Botanical Products, Including Dietary Supplements, Containing Aristolochic Acid April 11, 2001
* Comfrey
o FDA Advises Dietary Supplement Manufacturers to Remove Comfrey Products From the Market July 6, 2001
* Ephedrine Alkaloids
o see Consolidated Information on Ephedrine Alkaloids
* Kava
o Hepatic Toxicity Possibly Associated with Kava-Containing Products (CDC MMWR Report, November 29, 2002)
The Food and Drug Administration (FDA) is advising consumers of the potential risk of severe liver injury associated with the use of kava-containing dietary supplements.
o Consumer Advisory: Kava-Containing Dietary Supplements May be Associated With Severe Liver Injury March 25, 2002
o Letter to Health Care Professionals: FDA Issues Consumer Advisory That Kava Products May be Associated with Severe Liver Injury March 25, 2002
o Letter to Health Care Professionals about FDA Seeking Information on Liver Injury and Kava products December 19, 2001
* LipoKinetix: FDA Warns About Weight Loss Product
FDA alerts consumers and health care professionals about LipoKinetix, a dietary supplement weight loss product. This product has been implicated in a number of serious adverse reactions related to several cases of liver injury.
o FDA Warns Consumers Not to Use the Dietary Supplement LipoKinetix November 19, 2001
o Letter to Health Care Professionals on Hazardous Dietary Supplement LipoKinetix November 19, 2001
o Letter to Distributor on Hazardous Dietary Supplement LipoKinetix November 19, 2001
* Liqiang 4
o FDA Issues Nationwide Alert for "Liqiang 4" Due to Potential Health Risk July 1, 2005
* PC SPES and SPES
o MedWatch Safety Alert: Consumers Warned to Stop Using the Dietary Supplement/Herbal Products PC SPES and SPES February 8, 2002
* Red Yeast Rice
o FDA Warns Consumers to Avoid Red Yeast Rice Products Promoted on the Internet as Treatments for High Cholesterol August 9, 2007 *New*
* St. John's Wort and Indinavir
o FDA Public Health Advisory: Risk of Drug Interactions with St. John's Wort and Indinavir and Other Drugs February 10, 2000
* Tiractricol
o FDA Warns Consumers Against Consuming Dietary Supplements Containing Tiractricol November 21, 2000
* Triax Metabolic Accelerator
o FDA Warns Against Consuming Triax Metabolic Accelerator November 11, 1999
* Other FDA Alerts
o FDA Warns Consumers Not to Feed Infants "Better than Formula Ultra Infant Immune Booster 117" January 23, 2004
o FDA Warns Public About Chinese Diet Pills Containing Fenfluramine August 13, 2002
o FDA Recalls and Safety Alerts
o FDA Import Alerts and Import Detention Reports


Additional Safety Information

* Products Consumers Inquire About:
Ephedra or Ephedrine; DHEA (dehydroepiandrosterone); Melatonin; Dieter's Teas; L-Tryptophan; Folic Acid; Gamma Hydroxybutyric Acid (GHB); Gamma Butyrolactone (GBL); and 1,4 Butanediol (BD)
* MedWatch New Safety Information Summaries:
2002 / 2001 / 2000 / 1999 / 1998 / 1997 / 1996
* Archived Information: FDA Warning Statements Issued from 1993 to 2000
* Buying Medicines and Medical Products Online
* Other Sources of Safety Information (such as NIH, USDA, etc.)
* Letter to Stakeholders Regarding Contract on Dietary Supplement Safety Issues December 15, 2000

image of registry return receipt of letter addressed to Makati councilor J. J. Binay

image of registry return receipt of letter addressed to Makati councilor J. J. Binay