Beware of restaurants at Robinsons Ermita; deadly weapons into Ayala Center, Makati & Robinsons Ermita; etc.

Beware of following restaurants at Robinson's Ermita: Mangyan, Aristocrat, Karate Kid, Chow King.

Deadly weapons could, on July 3, 2008, have been brought into: (1) Park Square 1, SM food court, SM department store, all at Ayala Center, Makati; (2) Robinsons Ermita. Details available.

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

http://www.fda.gov/consumer/updates/biologics062608.html
FDA 101: Biological Products

* What biological products does FDA regulate?
* How do biologics differ from conventional drugs?
* What is FDA's role regarding biological products?
* What are the responsibilities of a licensed biologics manufacturer?
* How can adverse events related to biologic products be reported?

Biological products often represent the cutting edge of medical science and research. Also known as biologics, these products replicate natural substances such as enzymes, antibodies, or hormones in our bodies.

Biological products can be composed of sugars, proteins, or nucleic acids, or a combination of these substances. They may also be living entities, such as cells and tissues. Biologics are made from a variety of natural resources—human, animal, and microorganism—and may be produced by biotechnology methods.

Gene-based and cellular biologics, at the forefront of biomedical research today, may make it possible to treat a variety of medical conditions, including illnesses for which no other treatments are available. Research continues to develop more biologics that will help treat medical conditions or add to existing treatment options.

Here are answers to some frequently asked questions about this diverse and highly important field.

What biological products does FDA regulate?

The Center for Biologics Evaluation and Research (CBER) within FDA regulates a wide range of biological products, including

* allergenic extracts (e.g. for allergy shots and tests)
* blood and blood components
* gene therapy products
* devices and test kits
* human tissue and cellular products used in transplantation
* vaccines


How do biologics differ from conventional drugs?

Most drugs consist of pure chemical substances and their structures are known. Most biologics, however, are complex mixtures that are not easily identified or characterized. Biological products differ from conventional drugs in that they tend to be heat-sensitive and susceptible to microbial contamination. This requires sterile processes to be applied from initial manufacturing steps.


What is FDA's role regarding biological products?

CBER's regulatory authority for the approval of biologics resides in the Public Health Service Act (PHS). However, biologics are also subject to regulation under the Federal Food, Drug, and Cosmetic Act (FD&C Act) because most biological products also meet the definition of "drugs" cited within this Act.

Similarly, some medical devices used to produce biologics are regulated by CBER under the FD&C Act's Medical Device Amendments of 1976.

Through CBER, FDA also

* reviews new biological products and new indications and usage for already approved products in order to get biological products on the market for the treatment of known diseases
* helps protect against threats of emerging infectious diseases
* helps provide the public with information to promote the safe and appropriate use of biological products
* conducts inspections of plants that manufacture biologics before product approval is granted, and thereafter, on a regular basis
* monitors the safety of biological products after they are marketed

The PHS Act also

* allows FDA to approve biological products and immediately suspend licenses where there exists a danger to public health
* allows the agency to prepare or procure products in the event of shortages and critical public health needs
* enforces regulations to prevent the introduction or spread of communicable diseases within the country and between states


What are the responsibilities of a licensed biologics manufacturer?

The PHS Act requires individuals or companies who manufacture biologics for introduction into interstate commerce to hold a license for the products. These licenses are generally issued by CBER.

Some responsibilities of a licensed biologics manufacturer include

* complying with the appropriate laws and regulations relevant to their biologics license and identifying any changes needed to help ensure product quality
* reporting certain problems to FDA's Biological Product Deviation Reporting System
* reporting and correcting product problems within established timeframes
* recalling or stopping the manufacture of a product if a significant problem is detected


http://www.fda.gov/consumer/updates/travel_health062308.html
Stay Healthy While Traveling Abroad

* Before You Go
* Tips for the Trip
* While in Developing Countries
* Illnesses to Avoid
* When You Return

Are you planning a trip to other countries? Remember: healthy travel requires planning, preparation, self-discipline, and
vigilance.



In the Guide to International Inspections, FDA advises employees on safe and healthy travel basics. Here are a few pointers
that can help you stay healthy, too.


Before You Go

Do some research. Learn about access to reliable medical care at your destination. Also read up on current events there.
Good resources include

* The Centers for Disease Control and Prevention (CDC) Travelers' Health (wwwn.cdc.gov/travel/default.aspx)
* The CIA World Fact Book (https://www.cia.gov/library/publications/the-world-factbook/index.html)
* U.S. Department of State Travel Information (http://travel.state.gov/travel/cis_pa_tw/cis/cis_1765.html)

Don't buy medicines abroad. Many drugs sold in developing countries contain impure or toxic ingredients. Don't buy any
medical product without consulting a competent health care professional.

Take an ample supply of medications. Keep prescription and over-the-counter medications in their original packaging to
avoid problems with border guards. Carry one or two days' worth of prescription medicine to cover unexpected delays.
Consider carrying sunscreen and protection against insects, as well as treatments for the common cold; constipation; cuts,
scratches, and burns; diarrhea; heartburn or indigestion; insomnia; motion sickness; allergies; nasal congestion; pain or
fever; sore throat; and malaria prevention.

Don't use Entero-Vioform. This drug, widely distributed abroad for treating diarrhea, has been linked to nervous system
complications.

Think about immunizations. Consult your health care professional weeks in advance,
since some immunizations are administered over weeks or months.

Consider altitude. Even healthy, athletic people can become ill at altitudes above 10,000 feet. Young children are
especially at risk. If you're going to high altitudes, plan to rest during the first 12 to 24 hours there to adjust to
breathing in less oxygen. People with chronic heart and lung disorders should consult a physician before traveling to
altitudes above 3,000 feet.


Tips for the Trip

Exercise. During long trips, help avoid circulatory problems in your legs by standing up and walking for several minutes
every hour or so.

Eat and drink wisely. Drink plenty of liquids. Avoid overindulgence. Too much alcohol and/or food can result in
gastrointestinal problems, poor sleep, and altered moods.

Fight off jet lag. Minimize fatigue associated with time-zone hopping by eating normally. Try to get a good initial
night's sleep at your destination.


While in Developing Countries

Avoid tap water in all forms. This includes ice, water by the glass or in mixed drinks, and water used when brushing your
teeth. In developing countries, water may be contaminated by such unpleasantries as amoebas and other parasites, and the
virus that causes hepatitis. Even a small amount of infected water can make you ill.

Drink safe beverages. These include

* Boiled water – one minute of boiling is adequate.
* Hot beverages – these are relatively safe even if full boiling is not assured.
* Bottled water – carbonated water is the best assurance that the container was just opened and not filled at the tap.
* Bottled or canned beverages
* Treated water – commercial iodine or chlorine tablets provide substantial protection if added to tap water and allowed to stand according to the directions.

Avoid raw fruits and vegetables. This includes salads and uncooked vegetables. Eat only food that has been cooked and is still hot, or fruit that has been washed in clean water and that you have peeled. Fruits and vegetables that grow near to the ground are likely to be contaminated by the same organisms as the tap water.

Avoid other foods. These include

* Raw or undercooked meat, poultry, fish and eggs
* Dairy products from small independent vendors
* Food that has been left unrefrigerated, especially food containing meat, poultry, eggs and dairy products

Eat safe foods. These include

* Thoroughly cooked fruits and vegetables
* Fruits with a thick covering (citrus fruits, bananas, and melons), which you peel yourself
* Thoroughly cooked meat, poultry, eggs and fish. (Pork and lamb should be well done; beef can be medium)
* Dairy products from large commercial dairies


Illnesses to Avoid

Diarrhea. The most common cause of tourists' diarrhea can be treated with over-the-counter, "upset-stomach" products. (Buy these before you leave.) Effective drugs that control the frequency of diarrhea include Lomotil (diphenoxylate), lmodium (loperamide), and Kaopectate. Remember that adequate fluid intake is essential to preventing dehydration. Find reliable medical help if you have severe abdominal cramps, severe abdominal pain, high fever, blood or mucus in your stool, and/or severe dehydration.

Respiratory diseases. Many diseases—including influenza, tuberculosis, and diphtheria—are spread through sneezing, coughing, or talking. Consult your physician about testing and immunization.

Mosquito-borne diseases. These include malaria, yellow fever, dengue, and Japanese B encephalitis. To avoid mosquitoes

* Bring plenty of liquid mosquito repellent with at least 30% of the active ingredient Diethyltoluamide (DEET).
* Wear long sleeves and long pants.
* Sleep in a bed protected by mosquito netting, if needed.

Schistosomiasis. Swimmers need to know that many freshwater ponds in South America, Africa, and Asia are infested with a parasite that causes a chronic disease called schistosomiasis. Chlorinated pools and salt water are generally safe from infectious diseases.





Date Posted: June 23, 2008



http://www.fda.gov/consumer/updates/wrinklefillers062608.html
Wrinkle Relief: Injectable Cosmetic Fillers
* Uses
* Filler Materials
* Risks
* Tips for Consumers
* What About Botox?

In the quest for youth—or at least a more youthful appearance—women and men are seeking treatments to minimize laugh lines, crow's feet, and forehead furrows. A popular treatment involves injecting cosmetic wrinkle fillers into the face.

Injectable cosmetic wrinkle fillers are soft tissue fillers approved as medical devices by the Food and Drug Administration (FDA). These devices are injected into the skin to help fill in facial wrinkles, restoring a smoother appearance. Most of these wrinkle fillers are temporary because they are eventually absorbed by the body.

Some people may need more than one injection to achieve the wrinkle-smoothing effect. The effect lasts for about six months or longer.

Successful results depend on

* health of the skin
* skill of the doctor
* type of filler used

back to top
Uses

FDA has approved absorbable injectable cosmetic wrinkle fillers for correcting soft tissue contour defects, such as moderate and severe wrinkles and folds. Some absorbable fillers are approved for restoring or correcting the signs of facial fat loss in people with human immunodeficiency virus (HIV).

The only non-absorbable FDA-approved injectable cosmetic wrinkle filler is for correcting facial tissue around the mouth.

FDA-approved cosmetic wrinkle fillers should not be used for

* plumping the lips (lip augmentation)
* increasing breast size (breast augmentation)
* implanting into bone, tendon, ligament, or muscle
* implanting into blood vessels

Filler Materials

Wrinkle fillers are made of various types of materials, and some include a combination of products. Some products also contain lidocaine, which numbs the skin at the injection site.

The materials used in injectable cosmetic wrinkle fillers include

Temporary (absorbable) fillers

* Collagen injections are made of highly purified cow or human collagen. Collagen is a natural protein that is a major component of skin and other tissues in the body.
* Hyaluronic acid gel is a protective lubricating gel, produced naturally by the body, that binds with water to plump the skin.
* Calcium hydroxylapatite is a mineral that is a major component of bone. Calcium hydroxylapatite is a well-matched (biocompatible) material that dissolves in the body (biodegradable) and is implanted in the form of a gel.
* Poly-L-lactic acid (PLLA) is a biodegradable, biocompatible, synthetic material from the alpha-hydroxy-acid family that has been widely used for many years in dissolvable stitches and bone screws.

Permanent (non-absorbable) filler

* Polymethylmethacrylate beads (PMMA microspheres) are tiny round, smooth plastic particles that have been tested to be biocompatible. They are not absorbed by the body.

back to top
Risks

Getting injected with cosmetic wrinkle fillers is an elective procedure. As with any medical procedure, it poses risks.

Possible side effects include

* infection
* bruising
* redness
* swelling
* pain
* tenderness
* itching and rash
* raised bumps of skin (nodules or granulomas) that may need to be surgically removed
* death of skin, which may cause disfiguration, if the cosmetic wrinkle filler is injected and blocks a blood vessel
* sore (abscess) at the injection site
* wrinkle filler that breaks through the skin
* open or draining wounds
* blurred vision and flu-like symptoms
* increased allergic reaction that may lead to a severe allergic reaction (anaphylactic shock) that requires emergency medical help. (Your doctor may request a pre-treatment allergy test to determine if you are allergic to the filler.)

Most side effects occur shortly after injection and go away within seven days. In some cases, side effects may emerge weeks, months, or years later. A non-absorbable filler may cause long-term side effects.

You should not use cosmetic wrinkle fillers if any of the following applies to you:

* severe allergies marked by a history of anaphylactic shock
* allergy to cow collagen or eggs
* allergy to lidocaine
* inflamed or infected skin
* prone to form excessive scarring (keloid) or thick scarring (hypertrophic scars)
* bleeding disorder
* active inflammatory condition (cysts, pimples, rashes or hives) or infection; you should postpone treatment until the condition is controlled.

back to top
Tips for Consumers

Before deciding to get injected with a cosmetic wrinkle filler:

* Be aware that the safety of these products is unknown for use in pregnant or breastfeeding women or in patients under 18 years of age.
* Be aware that the safety is unknown when these products are used with Botox or other wrinkle therapies.
* Be aware that the safety of these fillers has only been studied when used in the face.
* Know the type of product that will be injected and all of its possible side effects.
* Discuss fillers with a doctor who can refer you to a specialist in the fields of dermatology and aesthetic plastic surgery.
* Select a doctor who is trained to do the procedure. (You may want to contact the American Academy of Dermatology at www.aad.org or the American Society for Aesthetic Plastic Surgery at www.surgery.org.)
* Have realistic expectations about the benefits you want to achieve and discuss them with your doctor.

This article appears on FDA's Consumer Health Information Web page (www.fda.gov/consumer), which features the latest on all FDA-regulated products. Sign up for free e-mail subscriptions at www.fda.gov/consumer/consumerenews.html.

horizontal rule
What About Botox?

Botox Cosmetic is an injectable drug, but it is not a wrinkle filler. Instead of filling the wrinkle, it keeps muscles from tightening so the wrinkles don’t show as much. FDA has approved Botox Cosmetic only to treat wrinkles between the eyebrows.
For More Information

Get the Facts: Botox
www.fda.gov/womens/getthefacts/botox.html

Adverse Reactions Linked to Botox
www.fda.gov/consumer/updates/botox020808.html



http://www.nichd.nih.gov/publications/pubs/safe_sleep_gen.cfm
Safe Sleep for Your Baby Ten Ways to Reduce the Risk of Sudden Infant Death Syndrome (SIDS) (General Outreach)



Safe Sleep for Your Baby: Ten Ways to Reduce the Risk of Sudden Infant Death Syndrome (SIDS) (General Outreach)

Babies Sleep Safer on Their Backs - brochure coverContents

* What is SIDS?

* What should I know about SIDS?

* What can I do to lower my baby's risk of SIDS?
Safe Sleep Top 10

* Babies sleep safest on their backs.

* Spread the word!




What is SIDS?

SIDS stands for sudden infant death syndrome. This term describes the sudden, unexplained death of an infant younger than 1 year of age.

Some people call SIDS "crib death" because many babies who die of SIDS are found in their cribs. But, cribs don't cause SIDS.


What should I know about SIDS?

Fast Facts About SIDS

* SIDS is the leading cause of death in infants between 1 month and 1 year of age.

* Most SIDS deaths happen when babies are between 2 months and 4 months of age.

* African American babies are more than 2 times as likely to die of SIDS as white babies.

* American Indian/Alaskan Native babies are nearly 3 times as likely to die of SIDS as white babies

Health care providers don't know exactly what causes SIDS, but they do know:

* Babies sleep safer on their backs. Babies who sleep on their stomachs are much more likely to die of SIDS than babies who sleep on their backs.

* Sleep surface matters. Babies who sleep on or under soft bedding are more likely to die of SIDS.

* Every sleep time counts. Babies who usually sleep on their backs but who are then placed on their stomachs, like for a nap, are at very high risk for SIDS. So it's important for everyone who cares for your baby to use the back sleep position for naps and at night.

What can I do to lower my baby's risk of SIDS?

Here are 10 ways that you and others who care for your baby can reduce the risk of SIDS.

Safe Sleep Top 10

1. Always place your baby on his or her back to sleep, for naps and at night. The back sleep position is the safest, and every sleep time counts.

2. Place your baby on a firm sleep surface, such as on a safety-approved crib mattress, covered by a fitted sheet. Never place your baby to sleep on pillows, quilts, sheepskins, or other soft surfaces.

3. If you use a blanket, place the baby with feet at the end of the crib. The blanket should reach no higher than the baby's chest. Tuck the ends of the blanket under the crib mattress to ensure safety.Keep soft objects, toys, and loose bedding out of your baby's sleep area. Don't use pillows, blankets, quilts, sheepskins, and pillow-like crib bumpers in your baby's sleep area, and keep any other items away from your baby's face.

4. Do not allow smoking around your baby. Don't smoke before or after the birth of your baby, and don't let others smoke around your baby.

5. Keep your baby's sleep area close to, but separate from, where you and others sleep. Your baby should not sleep in a bed or on a couch or armchair with adults or other children, but he or she can sleep in the same room as you. If you bring the baby into bed with you to breastfeed, put him or her back in a separate sleep area, such as a bassinet, crib, cradle, or a bedside cosleeper (infant bed that attaches to an adult bed) when finished.

5.


6. Always place your baby on his or her Back to Sleep.Think about using a clean, dry pacifier when placing the infant down to sleep,
but don't force the baby to take it. (If you are breastfeeding your baby, wait until your child is 1 month old or is used to breastfeeding before using a pacifier.)

7. Do not let your baby overheat during sleep. Dress your baby in light sleep clothing, and keep the room at a temperature that is comfortable for an adult.

8. Avoid products that claim to reduce the risk of SIDS because most have not been tested for effectiveness or safety.

9. Do not use home monitors to reduce the risk of SIDS. If you have questions about using monitors for other conditions talk to your health care provider.

10. Your baby needs Tummy Time! Place babies on their stomachs when they are awake and someone is watching. Tummy time helps your baby's head and neck muscles get stronger and helps to prevent flat spots on the head.
Reduce the chance that flat spots will develop on your baby's head: provide "Tummy Time" when your baby is awake and someone is watching; change the direction that your baby lies in the crib from one week to the next; and avoid too much time in car seats, carriers, and bouncers.



Babies sleep safest on their backs.

One of the easiest ways to lower your baby's risk of SIDS is to put him or her on the back to sleep, for naps and at night. Health care providers used to think that babies should sleep on their stomachs, but research now shows that babies are less likely to die of SIDS when they sleep on their backs. Placing your baby on his or her back to sleep is the number one way to reduce the risk of SIDS.

But won't my baby choke if he or she sleeps on his or her back?
No. Healthy babies automatically swallow or cough up fluids. There has been no increase in choking or other problems for babies who sleep on their backs.

Spread the word!

Make sure everyone who cares for your baby knows the Safe Sleep Top 10! Tell grandparents, babysitters, childcare providers, and other caregivers to always place your baby on his or her back to sleep to reduce the risk of SIDS. Babies who usually sleep on their backs but who are then placed on their stomachs, even for a nap, are at very high risk for SIDS—so every sleep time counts!




For more information on sleep position
for babies and reducing the risk of SIDS,
contact the Back to Sleep campaign at:
Phone: 1-800-505-CRIB (2742)
Mail: 31 Center Drive, Room 2A32, Bethesda, MD 20892
Fax: (301) 496-7101
Web site: http://www.nichd.nih.gov/SIDS