evidence vs. National Book store
On October 28, 2007, a person at the entrance to National book store branch, which was opposite SM Makati building at Ayala Center, Makati, didn't inspect my luggage/subject my luggage to scanning with metal detector. Said luggage
was large enough to contain deadly weapons.An employee, identified as Emily P. Serrano, who was identified as an employee of said store, received my written complaint regarding said security lapse. Up to May 28, 2010, nobody from said National Book store has provided me with a reply to said report of said security lapse.




On May 29, 2010:

Nobody inspected my waist bag which was large enough to contain a deadly weapon:
(1) When I entered Robinsons Ermita via the Adriatico entrance.
(2) and my luggage, when I (a) entered National Book store at said mall. Said luggage was large enough to contain deadly weapons (b) when I entered Robinsons supermarket within said mall. While I was at said supermarket, there was no visible required: (1) express lane for senior citizens in the customer area
of said store; (2) required sign in the customer area of said store re privileges of/for senior citizens.
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cancer about com web site
http://cancer.about.com/
____________________________________________________________________________________ FDA Drug Safety Communication: Completed safety review of Xenical/Alli (orlistat) and severe liver injury
http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm213038.htm

Safety Announcement
Additional Information for Patients and Consumers
Additional Information for Healthcare Professionals
Data Summary


Safety Announcement

[05-26-2010] The U.S. Food and Drug Administration (FDA) has approved a revised label for Xenical to include new safety information about cases of severe liver injury that have been reported rarely with the use of this medication. The agency is also adding a new warning about rare reports of severe liver injury to the OTC Drug Facts label for Alli and is working with the manufacturer to ensure that consumers can understand this new warning.

Xenical and Alli are medications used for weight-loss that contain different strengths of the same active ingredient, orlistat. Xenical (orlistat 120 mg) is available by prescription and Alli (orlistat 60 mg) is sold over-the-counter without a prescription.

This new safety information, originally announced in August 20091, is based on FDA's completed review that identified 13 total reports of severe liver injury with orlistat; 12 foreign reports with Xenical and 1 U.S. report with Alli (see Data Summary).

The following factors make confirming a cause-and-effect relationship between orlistat and severe liver injury difficult:

* One U.S. case with Alli and 12 foreign cases with Xenical reported between April 1999 and August 2009 out of an estimated 40 million people worldwide who have used Xenical or Alli.
* Some patients in the reported cases also used other drugs or had other conditions that may have contributed to the development of severe liver injury.
* Severe liver injury can occur in people not taking drugs and without a distinct cause.

At this time, a cause and effect relationship of severe liver injury with orlistat use has not been established. Because of the seriousness of severe liver injury, FDA has added information about reported cases of severe liver injury to the label of Xenical and Alli to educate the public about the signs and symptoms of liver injury and the need to see a physician promptly should they occur. The agency is also working with the manufacturer of Alli to ensure that consumers can understand this new warning


Additional Information for Patients and Consumers

* Be aware that cases of severe liver injury have been reported rarely in people taking Xenical and Alli.
* Contact your healthcare professional if you develop itching, yellow eyes or skin, dark urine, loss of appetite, or light-colored stools. These may be signs of liver injury.
* Talk to your healthcare professional about any concerns you have with these medications.
* Report any side effects with Xenical or Alli to FDA's MedWatch program using the information at the bottom of the page in the "Contact Us" box.


Additional Information for Healthcare Professionals

* Be aware that postmarketing cases of severe liver injury with hepatocellular necrosis or acute hepatic failure have been reported rarely in people using Xenical and Alli. Some of these cases resulted in liver transplant or death.
* Weigh the benefits of weight-loss with Xenical and Alli against the potential risks when determining if these medications are appropriate for patients.
* Instruct patients to report any symptoms of hepatic dysfunction (anorexia, pruritus, jaundice, dark urine, light colored stools, or right upper quadrant pain) when using these medications.
* If liver injury is suspected, orlistat and other suspect medications should be discontinued immediately and liver function tests and ALT and AST levels obtained.
* Report any adverse events with Xenical or Alli to FDA's MedWatch program using the information at the bottom of the page in the "Contact Us" box.


Data Summary

The decision to include information about severe liver injury in the drug label for Xenical and Alli is based on FDA's comprehensive review of all available data (pre-clinical, clinical trial, postmarketing, and drug utilization) on severe liver injury associated with Xenical through August 7, 2009, and a review of postmarket data on Alli through October 1, 2008. There were no signals of significant liver injury in either the pre-clinical studies or clinical trials data.

FDA identified 12 postmarketing cases of severe liver injury reported with the use of Xenical and one case reported with the use of Alli. In some of these cases, other factors or drugs may have contributed to the development of severe liver injury.

Of the 13 cases:

* Twelve were foreign reports of severe liver injury with Xenical.
* One was a U.S. report of severe liver injury with Alli.
* Two patients died from liver failure.
* Three patients required liver transplantation.


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Related Information

* Questions and Answers: Orlistat and Severe Liver Injury2
5/26/2010
* FDA: Rare Cases of Liver Injury Reported with Use of Xenical, Alli3
FDA press release (5/26/2010)
* Weight-Loss Drugs and Risk of Liver Failure4
FDA consumer update
* Early Communication about an Ongoing Safety Review Orlistat (marketed as Alli and Xenical)5
8/24/2009
* Orlistat (marketed as Alli and Xenical) Information6

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Labeling and Regulatory History from Drugs@FDA

* Xenical (orlistat) Prescribing and Labeling Information7
* Alli (orlistat) Prescribing and Labeling Information8
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FDA: Rare Cases of Liver Injury Reported with Use of Xenical, Alli

The U.S. Food and Drug Administration today advised consumers and health care professionals about potential rare occurrences of severe liver injury in patients taking the weight-loss medication orlistat, marketed as Xenical and Alli.

The FDA has approved a revised label for the prescription drug Xenical. The agency is working with the manufacturer of Alli on label revisions to reflect this rare occurrence.

Both Xenical and Alli are medications contain the same active ingredient, orlistat. Xenical, available only by prescription, contains 120 milligrams of orlistat. Alli, sold over-the-counter without a prescription, contains 60 mg of orlistat. An estimated 40 million people worldwide have taken either Xenical or Alli.

The FDA’s safety information and labeling changes are based on a review of cases of severe liver injury reported in individuals taking orlistat. The agency has identified 13 cases of severe liver injury, 12 of which were reports from outside of the United States. The only U.S. report of severe liver injury involved Alli. At this time, a cause-and-effect relationship of severe liver injury with orlistat use has not been established.

People who take Xenical or Alli should be aware that liver injury with orlistat – while rare – has been reported. Those taking the drug also should be aware of the signs and symptoms of liver injury, which include itching, yellow eyes or skin, dark urine, loss of appetite, or light-colored stools.

For more information:

* FDA Drug Safety Communication on Orlistat1
* FDA Questions and Answers about Orlistat2
* Consumer Update: Weight-Loss Drugs and Risk of Liver Failure3
* FDA August 2009 Early Communication on Orlistat4

RSS Feed for FDA News Releases5 [what is RSS?6]

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Links on this page:

1. http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm213038.htm
2. http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm213040.htm
3. http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm213401.htm
4. http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/DrugSafetyInformationforHeathcareProfessionals/ucm179166.htm
5. http://www.fda.gov/AboutFDA/ContactFDA/StayInformed/RSSFeeds/PressReleases/rss.xml
6. http://www.fda.gov/AboutFDA/ContactFDA/StayInformed/RSSFeeds/ucm144575.htm

Page Last Updated: 05/26/2010






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Food Safety for Moms-To-Be
http://www.fda.gov/Food/ResourcesForYou/HealthEducators/ucm081785.htm
foodborne illness is a serious health risk for pregnant women and their unborn babies. You'll find accurate, easy-to-understand information about foodborne illness.

(In English and Spanish1 / En inglés y español2)
At-A-Glance3

Here you'll find top line points about food safety during pregnancy. It's a great reminder of ways to keep you and your baby safe!
Before You're Pregnant4

Thinking about becoming pregnant? Before the test is positive, here's how to give your baby a healthy start!
While You're Pregnant5

Congratulations - you're pregnant! Here are answers to your frequently-asked questions about foodborne illness.
Safe Eats6

Is sushi safe? What about "smoothies?" This easy-to-use section provides a food-by-food guide to selecting, preparing, and eating foods safely.
Lifelong Food Safety7

Good food safety practices are important during your pregnancy and for a lifetime! This section shows you how to prevent foodborne illness in four easy steps: Clean, Separate, Cook, and Chill.
Highlights8

Entertaining All Year - Enjoy social events while keeping your unborn baby safe from foodborne bacteria.
A Special Note: As you learn more about food safety, you may discover that there are things related to safe food handling that you should have done differently in the past. Don't worry, you and your baby are probably okay! But if you do have health concerns, see your doctor or health-care provider.
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GENE PATTERN MAY IDENTIFY KIDNEY TRANSPLANT RECIPIENTS WHO DON'T NEED LIFE-LONG ANTI-REJECTION DRUGS
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Injection Safety FAQs for Patients
http://www.cdc.gov/injectionsafety/patients/patient_faqs.html
* What is injection safety?
* What are some of the incorrect practices that have resulted in transmission of disease?
* For what types of procedures have these incorrect practices been identified?
* Can some of these incorrect practices also result in transmission of bacterial infections?
* Do medication vials have a preservative in them to prevent contamination?

What is injection safety?

Injection safety, or safe injection practices, is a set of measures taken to perform injections in an optimally safe manner for patients, healthcare personnel, and others. A safe injection does not harm the recipient, does not expose the provider to any avoidable risks, and does not result in waste that is dangerous for the community. Injection safety includes practices intended to prevent transmission of infectious diseases between one patient and another, or between a patient and healthcare provider, and also to prevent harms such as needlestick injuries.



What are some of the incorrect practices that have resulted in transmission of disease?

Practices that have resulted in transmission of hepatitis C virus (HCV) and/or hepatitis B virus (HBV) include the following:

* Using the same syringe to administer medication to more than one patient, even if the needle was changed;
* Using the same medication vial for more than one patient, and accessing the vial with a syringe that has already been used to administer medication to a patient;
* Using a common bag of saline or other IV fluid for more than one patient, and accessing the bag with a syringe that has already been used to flush a patient's catheter.



For what types of procedures have these incorrect practices been identified?

Unsafe injection practices that put patients at risk for HCV, HBV and other infections have been identified during various types of procedures. Examples include the following:

* Administration of anesthetics for outpatient surgical, diagnostic and pain management procedures;
* Administration of other IV medications for chemotherapy, cosmetic procedures, and alternative medicine therapies;
* Use of saline to flush IV lines and catheters;
* Administration of intramuscular (IM) vaccines.

The involved medications were in single-use vials, multi-dose vials, and bags. What they had in common was the vials or bags were used for more than one patient and were entered with a syringe that had already been used for a patient; or the syringe itself was used for more than one patient.



Can some of these incorrect practices also result in transmission of bacterial infections?

Yes. These incorrect practices put patients at risk for bacterial, fungal, and viral infections.



Do medication vials have a preservative in them to prevent contamination?

Most multi-dose medication vials that are intended for several medication administrations have a preservative in them to prevent bacterial growth. Single-use vials do not contain a preservative. The preservative has no effect on viruses. Safe injection practices and appropriate aseptic technique are necessary to prevent bacterial and viral contamination of medication vials that can result in patient infections.




USA.gov: The U.S. Government's Official Web PortalDepartment of Health and Human Services
Centers for Disease Control and Prevention 1600 Clifton Rd. Atlanta, GA 30333, USA
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landscaping about web site
http://landscaping.about.com/
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NIH STUDY FINDS THAT OVERWEIGHT GIRLS WHO LOSE WEIGHT REDUCE ADULT DIABETES RISK
http://us.mc768.mail.yahoo.com/mc/welcome?.gx=1&.tm=1274973290&.rand=2kitfroqn1rta#_pg=showMessage&sMid=8&&filterBy=&.rand=200089951&midIndex=8&mid=1_31068831_AHd7bHwAAVXKS%2F5yHQuAkk91GrQ&fromId=olib@OD.NIH.GOV&m=1_31073254_AHB7bHwAAEonS%2F6ECQofhTuz7V0,1_31071942_AHh7bHwAATqHS%2F59PAFKZiP09e8,1_31072681_AHd7bHwAACsXS%2F59wA1iegvWy0c,1_31071098_AHd7bHwAABCES%2F57JgULvWCFjsg,1_31070125_AHN7bHwAAWoRS%2F539wjrzx8KUUc,1_31068831_AHd7bHwAAVXKS%2F5yHQuAkk91GrQ,1_31067244_AHZ7bHwAAGsFS%2F5nEQqjb1m5Ns0,1_31066656_AHR7bHwAAThxS%2F5mYApCRwYlvzU,1_31065078_AHB7bHwAAJehS%2F5bIQqnFVXjeu0,1_31066010_AHN7bHwAAIVwS%2F5bcAAbXFHqOZg,1_31064455_AHh7bHwAAB6VS%2F5aMA7E4EU2YAE,&sort=date&order=down&startMid=0&hash=f6449381ebb048f3206d11d49534dee4&.jsrand=2014913


____________________________________________________________________________________________________________________________________________________________________
Questions and Answers: Orlistat and Severe Liver Injury
http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm213040.htm

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Safe Injection Practices Prevent Infections
http://www.cdc.gov/Features/InjectionSafety/

Most people are surprised to hear that in the United States today, healthcare providers still make mistakes in giving injections that lead to the spread of
infections. Learn what you can do to protect yourself.

Learn About Safe Injection Practices

Safe Injection Practices are a set of recommendations that all healthcare providers should follow in any situation where injections are given. A key recommendation
is that providers should use one needle and one syringe only a single time. People don’t often think about it, but injections must be given in a certain way to
prevent patients from getting infections. These infections can be serious and life-threatening.

Some examples of unsafe injection practices include:

1. Reusing a needle or syringe to give medicine to more than one patient
2. Reusing a needle or syringe to take out medicine from a vial that is used for more than one patient.

Both the needle and syringe must be thrown away once they have been used. It is not safe for healthcare providers to change the needle and reuse the syringe – this
practice can spread disease.

Reusing a needle or syringe puts patients in danger of getting hepatitis C virus, hepatitis B virus, HIV, and other infections.
Ask Questions

Healthcare providers are responsible for making sure that every injection they give is safe. You can help protect yourself by asking your healthcare providers what
steps they take to ensure that needles and syringes are never reused and that medicines do not become contaminated.

Remember

Patients and healthcare providers should insist on nothing less than One Needle, One Syringe, Only One Time for each and every injection. This practice will lower the
risk of getting hepatitis and other infections through injections.

One Needle, One Syringe, Only One Time is the slogan of the One & Only Campaign, a public health campaign led by the Centers for Disease Control and Prevention (CDC)
and the Safe Injection Practices Coalition (SIPC), to raise awareness among patients and healthcare providers about safe injection practices.

More Information

* One & Only Campaign
* CDC Injection Safety Website
* CDC Safe Healthcare Blog
* CDC Viral Hepatitis Website
* CDC HIV/AIDS Website
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U.S. FDA New and Generic Drug Approvals

May 26, 2010

* Ciclopirox Shampoo, Nycomed US Inc., Approval
* Wellbutrin (bupropion hydrochloride) Tablets, GlaxoSmithKline, Labeling Revision
* Wellbutrin SR (bupropion hydrochloride) Extended-Release Tablets, GlaxoSmithKline, Labeling Revision
* Wellbutrin XL (bupropion hydrochloride) Extended-Release Tablets, Biovail Technologies, Ltd., Labeling Revision
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Possible Increased Risk of Bone Fractures With Certain Antacid Drugs
http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm213240.htm
There is a possible increased risk of fractures of the hip, wrist, and spine if you take certain drugs for heartburn, acid reflux, or ulcers, warns the Food and Drug Administration (FDA).

The drugs belong to a class of medications called proton pump inhibitors (PPIs), which work by reducing the amount of acid in the stomach. They are available both as prescription and as over-the-counter (OTC) medications.

The prescription PPIs treat conditions such as gastroesophageal reflux disease (GERD), ulcers in the stomach and small intestine, and inflammation of the esophagus. The PPIs available over-the-counter are used to treat frequent heartburn.

The prescription PPIs are

* Nexium
* Dexilant
* Prilosec
* Zegerid
* Prevacid
* Protonix
* Aciphex
* Vimovo

The over-the-counter PPIs are

* Prilosec OTC (omeprazole)
* Zegerid OTC (omeprazole)
* Prevacid 24HR (lansoprazole)

Advice for Consumers

* Do not stop taking your PPI unless you are told to do so by your health care professional. PPIs are effective in treating a variety of gastrointestinal disorders.
* Be aware that an increased risk of fractures of the hip, wrist, and spine have been reported in some studies of people who use PPIs. The greatest increased risk for these fractures was seen in those who receive high doses of these medications or use them for a year or longer.
* Read and follow the directions on the “Drug Facts” label when considering the use of an over-the-counter PPI.
* Be aware that the over-the-counter PPIs should only be used as directed for 14 days for the treatment of frequent heartburn. If your heartburn continues, talk to your health care professional. No more than three 14-day treatment courses should be used in one year.
* Talk to your health care professional about any concerns you may have about using PPIs.
* Report any side effects from the use of PPIs to FDA’s MedWatch Adverse Event Reporting Program either online, by regular mail, by fax, or by phone.
o Online4
o Regular Mail: Use postage-paid, pre-addressed FDA form 35005
o Fax: 1-800-FDA-0178
o Phone: 1-800-332-1088

FDA Actions

FDA has reviewed seven published studies, six of which reported an increased risk of fractures of the hip, wrist, and spine with the use of PPIs. Based on the available data, it is not clear at this time if the use of PPIs is the cause of the increased risk of fractures seen in some studies. FDA is working with the manufacturers of PPIs to further study this possible risk.

Most of the studies evaluated individuals 50 years of age or older, and the increased risk of fracture was seen mainly in this age group.

As a precaution, FDA is revising the labels for both the prescription and the over-the-counter PPIs to include new safety information about the possible increased risk of fractures of the hip, wrist, and spine with the use of these medications.

This article appears on FDA's Consumer Updates page6, which features the latest on all FDA-regulated products.

Date Posted: May 25, 2010
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For More Information

* FDA Drug Safety Communication: Possible increased risk of fractures of the hip, wrist, and spine with the use of proton pump inhibitors7

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