FDA Issues Warning Letters to Bayer HealthCare , etc.

Topics in this posting:

FDA Issues Warning Letters to Bayer HealthCare for Illegally Marketing Two Unapproved
Two Unapproved Drugs
http://www.fda.gov/bbs/topics/NEWS/2008/NEW01907.html

FDA News

FOR IMMEDIATE RELEASE
October 28, 2008




FDA Issues Warning Letters to Bayer HealthCare for Illegally Marketing Two Unapproved Drugs
Action involves Bayer Aspirin with Heart Advantage and Bayer Women’s Low Dose Aspirin + Calcium

The U.S. Food and Drug Administration today sent Warning Letters to Bayer HealthCare concerning two unlawful, over-the-counter (OTC) aspirin products — Bayer Women's Low Dose Aspirin + Calcium (Bayer Women's) and Bayer Aspirin with Heart Advantage (Bayer Heart Advantage).

The products, which contain aspirin with either phytosterols or calcium, are unapproved new drugs that require an approved new drug application in order to be legally marketed. In addition to being labeled for use as a pain reliever, both products are labeled for use in reducing the risks of heart disease. Bayer Women's is also labeled for use in "fighting" osteoporosis.

Neither product has been approved by the FDA for such uses. These drug uses require a health care professional's diagnosis and supervision, and therefore these products cannot be labeled for use by consumers and sold over-the-counter (OTC).

"The FDA considers these products new drugs and thus they must undergo the FDA's drug approval process," said Mike Chappell, the FDA's acting associate commissioner for regulatory affairs. "The FDA will take enforcement action against manufacturers
found to be violating the law or attempting to circumvent the drug approval process."

Bayer Heart Advantage combines aspirin and phytosterols in a single tablet. Bayer Women's combines aspirin and calcium carbonate in a single tablet. The products are labeled as being a combination of a drug and a dietary supplement, but when a
drug and a dietary supplement are combined in a single tablet, the product is regulated by FDA as a drug. According to the labeling, the phytosterols in Bayer Heart Advantage are intended to lower blood cholesterol and the calcium in Bayer Women's is intended to strengthen bones to fight osteoporosis. Although certain calcium-containing dietary supplements may bear claims to reduce the risk of osteoporosis, products that are labeled to "fight" or otherwise treat osteoporosis are drugs that require FDA approval. Similarly, although certain phytosterol-containing dietary supplements may bear claims to reduce the risk of coronary heart disease, and may note that the mechanism by which phytosterols achieve this effect is through lowering blood cholesterol, direct claims to lower cholesterol are claims to prevent or treat coronary heart disease and hypercholesterolemia, which is also a disease. Products bearing such claims require an approved new drug application from FDA in order to be legally marketed, and cannot be legally marketed for OTC use.

Under its OTC drug monograph system, FDA allows some drugs to be marketed without first obtaining agency approval. These drugs must comply with applicable monographs, that is, regulations that set requirements for the drugs' labeling and
formulation, as well as the indications (uses) for which the drugs can be marketed. OTC drugs that do not meet these requirements and that lack FDA approval are considered illegal, unapproved drugs. Bayer Heart Advantage and Bayer Women's do
not meet the conditions in any applicable OTC monograph, and do not have FDA approval. Therefore, Bayer Heart Advantage and Bayer Women's are unapproved new drugs.

In addition, Bayer Heart Advantage and Bayer Women's are misbranded because their labeling lacks adequate directions for use by consumers. In order for a drug to have adequate directions for use, the directions must be written so that consumers can
use the product safely for its intended purpose, without the supervision of a health care professional. The use of these products for treatment of heart disease and osteoporosis requires diagnosis and supervision by a health care professional to
ensure safe use. Therefore, it is not possible, in OTC drug product labeling, for these products to have adequate directions for their intended uses. The products also are misbranded because their labeling do not have adequate warnings and are
misleading. Among other things, the labeling for the aspirin in the products includes directions and warnings regarding short term use, but these directions and warnings are contradicted by other directions for the phytosterols and calcium that
promote the products' daily use without any time limits. The result is a mixed message about the products' purposes and the length of time for which the products can be safely used.

"The marketing of these unapproved drugs is troubling," said Janet Woodcock, M.D., director of the FDA's Center for Drug Evaluation and Research. "Because OTC drugs are widely used by consumers, without supervision by a doctor or other health care professional, the overuse or misuse of these aspirin-containing products can put consumers at risk for internal bleeding and other adverse events. It is essential that companies obtain FDA approval and fully comply with FDA regulations."

Although the FDA is not aware of significant adverse events associated with these products, the agency is concerned because neither product has been approved by FDA for its marketed uses.

Today's actions reaffirm the position taken by FDA in two previously issued Warning Letters - one sent to B.F. Ascher & Co., Inc., Lenexa, KS, regarding Melagesic PM, and the other to Omni Nutraceuticals, Inc., Los Angeles, CA regarding Inholtra
Joint Pain products. In those letters, the FDA stated that drug ingredients combined with dietary ingredients in a single dosage form require agency approval to be legally marketed in the United States.

Companies that do not resolve violations in FDA Warning Letters risk enforcement action, such as injunctions and/or seizure of illegal products.
For more information

Warning Letter: BAYER ASPIRIN With HEART ADVANTAGE
http://www.fda.gov/foi/warning_letters/s6991c.htm

Warning Letter: BAYER WOMEN'S Low Dose Aspirin + CALCIUM
http://www.fda.gov/foi/warning_letters/s6990c.htm

Questions and Answers for Consumers
http://www.fda.gov/consumer/updates/bayer102808.html

Thoratec Corporation Issues Worldwide Medical Device Correction of HeartMate II® Left Ventricular Assist System
http://www.fda.gov/oc/po/firmrecalls/thoratec10_08.html

Recall -- Firm Press Release

FDA posts press releases and other notices of recalls and market withdrawals from the firms involved as a service to consumers, the media, and other interested parties. FDA does not endorse either the product or the company.
Thoratec Corporation Issues Worldwide Medical Device Correction of HeartMate II® Left Ventricular Assist System

Contact:
Thoratec Corporation
1-800-528-2577

FOR IMMEDIATE RELEASE -- PLEASANTON, CA -- October 24, 2008—Thoratec Corporation is initiating a worldwide medical device correction of all serial numbers of the HeartMate II Left Ventricular Assist Systems (HM II LVAS) having Catalogue No. 1355
or 102139, which have been distributed since the beginning of clinical studies in November 2003. Over time, wear and fatigue of the percutaneous lead connecting the HeartMate II LVAS blood pump with the System Controller may result in damage that
could interrupt pump function, require reoperation to replace the pump and potentially result in serious injury or death. The estimated probability of the need for pump replacement due to percutaneous lead damage is 1.3% at 12 months, 6.5% at 24
months and 11.4% at 36 months.

Patients who are currently being supported by a HeartMate II LVAS should contact their doctors, who can assess the wear and fatigue of the percutaneous lead as well as provide proper instruction on management and care of the lead.

Thoratec is voluntarily issuing an Urgent Medical Device Correction notice after confirming 27 reports where wear and fatigue to the percutaneous lead necessitated pump replacement. These reports occurred over five years of clinical experience with
1,972 implants. All patients who have undergone a replacement of the HeartMate II pump survived the operation and were alive at least 30 days postoperatively. In five cases, pump replacement was not feasible and the patients expired.

The affected systems were distributed to 153 hospitals and distributors throughout the United States, Europe, Canada and other countries. The HM II LVAS can be identified by the catalogue number located on the label of the package.

Hospitals are being sent an Urgent Medical Device Correction letter identifying the probability and symptoms of the problem, and recommending that the pump be replaced as soon as possible if damage to the percutaneous lead is confirmed. Hospitals are
also requested to review the instructions for care of the percutaneous lead with their ongoing HeartMate II LVAS patients.

Hospitals with ongoing HeartMate II LVAS patients should contact Thoratec for further instructions if they do not receive the Medical Device Correction letter. The labeling for the HeartMate II LVAS will be revised with the updated risk information
related to percutaneous lead damage. Copies of this press release may be found on Thoratec’s website, www.thoratec.com, under Investor Relations/Press Releases.

Clinicians and patients with questions may contact the company at 1-800-528-2577, or if calling from outside the USA, 1-925-847-8600 (7 days a week, 8-5 Pacific Time).

FDA has been informed of this action.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
• Online: www.fda.gov/medwatch/report.htm
• Regular Mail: use postage-paid FDA form 3500 available at:
www.fda.gov/MedWatch/getforms.htm. Mail to MedWatch 5600 Fi


Serta International Recalls Mattresses Due to Violation of Federal Mattress Flammability Standard
http://www.cpsc.gov/cpscpub/prerel/prhtml09/09025.html

NEWS from CPSC
U.S. Consumer Product Safety Commission
Office of Information and Public Affairs Washington, DC 20207
FOR IMMEDIATE RELEASE
October 28, 2008
Release #09-025

Firm's Recall Hotline: (866) 675-3853
CPSC Recall Hotline: (800) 638-2772
CPSC Media Contact: (301) 504-7908
Serta International Recalls Mattresses Due to Violation of Federal Mattress Flammability Standard

WASHINGTON, D.C. - The U.S. Consumer Product Safety Commission, in cooperation with the firm named below, today announced a voluntary recall of the following consumer product. Consumers should stop using recalled products immediately unless otherwise instructed.

Name of Product: Serta Zipper-Covered Foam Core Mattresses

Units: About 6,100

Manufacturer: Serta International Mattress Co., of Hoffman Estates, Ill.

Hazard: The mattresses fail to meet the mandatory federal open flame standard for mattresses, posing a fire hazard to consumers.

Incidents/Injuries: None reported.

Description: The recalled mattresses have a zipper cover over a foam core. The mattresses were sold in twin, full, queen, king and California king sizes. They were manufactured between November 30, 2007 and May 20, 2008. The mattress name, date of
manufacture, model, and serial numbers are located on label attached to the mattress. Only specific serial numbers are included in the recall. The recalled mattresses are listed in the chart below.
Mattress Name Model Number Serial Number
Serene Signature Zip 810098, 810298,
810198, 810598 Contact Serta to determine if
your serial number is included
in the recall.
Accord Zip 830098
Perpetual Zip 830298, 830498
Solara Zip 830798
Solara II Zip 830898
Compass Zip 830198, 831598
Bellbrook Zip 830398
Elysian Zip 830698
Allington Zip 831098
Araceli Zip 831498
Royce Select Zip 831698

Sold at: Mattress retailers nationwide from December 2007 through May 2008 for up to $2,500.

Manufactured in: United States

Remedy: Consumers should immediately contact Serta to determine if their mattress is included in the recall, and if it is, to

receive a free replacement mattress cover. Consumers can install the cover themselves or request free installation by a

qualified repair technician.

Consumer Contact: For additional information, contact Serta toll-free at (866) 675-3853shers Lane, Rockville, MD
20852-9787
• Fax: 1-800-FDA-0178
http://wwwn.cdc.gov/travel/yellowBookCh2-HealthKit.aspx
Pre- and Post-travel General Health Recommendations

Travelers' Health Kit

The purpose of a Travel Kit is twofold: to allow the traveler to take care of minor health problems as they occur and to

treat exacerbations of pre-existing medical conditions. Persons with pre-existing conditions, such as diabetes or allergies

to envenomations or medications, should consider wearing an alert bracelet and making sure this information is on a card in

their wallet and with their other travel documents. A variety of health kits are available commercially and may even be purchased over the Internet (see below); however, similar kits can be assembled at home. The specific contents of the health kit are based on destination, duration of travel, type of travel, and the traveler’s pre-existing medical conditions. Basic items that should be included are listed below. See also Chapters 8 and 9 for additional suggestions that may be useful in planning the contents of the kit.

Medications

* Personal prescription medications in their original containers (copies of all prescriptions should be carried, including the generic names for medications, and a note from the prescribing physician on letterhead stationery for controlled substances and injectable medications)
* Antimalarial medications, if applicable
* Over-the-counter antidiarrheal medication (e.g., bismuth subsalicylate, loperamide)
* Antibiotic for self-treatment of moderate to severe diarrhea
* Antihistamine
* Decongestant, alone or in combination with antihistamine
* Anti-motion sickness medication
* Acetaminophen, aspirin, ibuprofen, or other medication for pain or fever
* Mild laxative
* Cough suppressant/expectorant
* Throat lozenges
* Antacid
* Antifungal and antibacterial ointments or creams
* 1% hydrocortisone cream
* Epinephrine auto-injector (e.g., EpiPen), especially if history of severe allergic reaction. Also available in smaller-dose package for children.

Other Important Items

* Insect repellent containing DEET (up to 50%)
* Sunscreen (preferably SPF 15 or greater)
* Aloe gel for sunburns
* Digital thermometer
* Oral rehydration solution packets
* Basic first-aid items (adhesive bandages, gauze, ace wrap, antiseptic, tweez-ers, scissors, cotton-tipped applicators)
* Antibacterial hand wipes or alcohol-based hand sanitizer containing at least 60% alcohol (1)
* Moleskin for blisters
* Lubricating eye drops
* First aid quick reference card

Other items that may be useful in certain circumstances

* Mild sedative (e.g., zolpidem) or other sleep aid
* Anti-anxiety medication
* High-altitude preventive medication
* Water purification tablets
* Commercial suture/syringe kits (to be used by local health-care provider. These items will also require a letter from the prescribing physician on letterhead stationery.)
* Latex condoms
* Address and phone numbers of area hospitals or clinics

Commercial medical kits are available for a wide range of circumstances, from basic first aid to advanced emergency life support. Many outdoor sporting goods stores sell their own basic first aid kits. For more adventurous travelers, a number of
companies produce advanced medical kits and will even customize kits based on specific travel needs. In addition, specialty kits are available for managing diabetes, dealing with dental emergencies, and handling aquatic environments. If travelers choose to purchase a health kit rather than assemble their own, they should be certain to review the contents of the kit carefully to ensure that it has everything needed; additional items may be necessary.

Below is a list of websites supplying a wide range of medical kits. There are many suppliers, and this list is not meant to be all inclusive.

* Adventure Medical Kits
* Chinook Medical Gear
* Harris International Health Care
* Travel Medicine, Inc.
* Wilderness Medicine Outfitters

A final reminder: a health kit is useful only if it is available. It should be carried with the traveler at all times, e.g., in carry-on baggage when allowable, and on excursions. All medications, especially prescription medications, should be stored
in carry-on baggage, in their original containers with clear labels. With heightened airline security, sharp objects and some liquids and gels will have to remain in checked luggage.

References

1. Reynolds SA, Levy F, Walker ES. Hand sanitizer alert [letter]. Emerg Infect Dis [serial on the Internet]. 2006 Mar [28

March 2007]. Available from http://www.cdc.gov/ncidod/EID/vol12no03/ 05-0955.htm.

http://www.cdc.gov/Features/TravelHealthKit/
Travelers' Health Kit
Attention, international travelers! Save room in your suitcase for your Travelers' Health Kit. Use this as a guide for packing items you will need to stay healthy on your trip—such as sunscreen and insect repellent, prescription medicines, and
basic first-aid items.



A sample travelers' health kit

There's a lot to think about when you are preparing to travel to a different country! When you're planning what to take on

your trip, don't forget to pack a Travelers' Health Kit in your luggage. It's a good idea to keep all medicines, especially prescriptions, in your carry-on bags. Because of airline security rules, sharp objects and some liquids and gels will have to
remain in checked luggage.

Here are a few items you might want to include in your kit.

1. Basic First-Aid Items

* Adhesive bandages
* Gauze
* Elastic wrap for sprains
* Antiseptic
* Tweezers
* Scissors
* Digital thermometer
* Antibacterial and antifungal ointments/creams
* 1% hydrocortisone cream
* Moleskin for blisters
* Aloe gel for sunburns
* Lubricating eye drops
* First-aid quick reference card

2. Medicines

* Acetaminophen, aspirin, ibuprofen, or another medicine for pain or fever
* Antacid
* Over-the-counter antidiarrheal medicine (such as bismuth subsalicylate or loperamide)
* Antibiotic for self-treatment of moderate to severe diarrhea
* Oral rehydration solution packets
* Mild laxative
* Antihistamine
* Decongestant (alone or in combination with antihistamine)
* Cough suppressant/expectorant
* Throat lozenges
* Personal medicines:
o Any prescription or over-the-counter drugs you take on a regular basis
o Epinephrine auto-injector (such as EpiPen), if you have a severe allergy
o Anti-malaria drugs, if needed

3. Other Important Items

* Insect repellent
* Sunscreen (at least SPF 15)
* Antibacterial hand wipes or an alcohol-based hand sanitizer (with at least 60% alcohol)
* Other items, depending on your destination and possible activities:
o Water purification tablets
o Mild sedative (such as zolpidem) or other sleep aid
o Anti-anxiety medicine
o Medicine to prevent or treat altitude illness
o Latex condoms

Passenger jet landing

4. Contact Card

* Address/phone numbers of area hospitals or clinics
* Address/phone number of (the Philippine) Embassy or Consulate in your destination
When you travel with medicines:
* Make sure you carry them in their original containers with clear labels, so it's clear what medicines they are.
* If you are taking any prescription medicines, carry along a copy of the prescription, including the generic names for medicines.
* If you are carrying any controlled substances or injectable medicines, carry a note on letterhead stationery from your doctor to explain your reason for having this medicine.




Serta International Recalls Mattresses Due to Violation of Federal Mattress Flammability Standard
http://www.cpsc.gov/cpscpub/prerel/prhtml09/09025.html

NEWS from CPSC
U.S. Consumer Product Safety Commission
Office of Information and Public Affairs Washington, DC 20207

FOR IMMEDIATE RELEASE
October 28, 2008
Release #09-025

Firm's Recall Hotline: (866) 675-3853
CPSC Recall Hotline: (800) 638-2772
CPSC Media Contact: (301) 504-7908
Serta International Recalls Mattresses Due to Violation of Federal Mattress Flammability Standard

WASHINGTON, D.C. - The U.S. Consumer Product Safety Commission, in cooperation with the firm named below, today announced a voluntary recall of the following consumer product. Consumers should stop using recalled products immediately unless
otherwise instructed.

Name of Product: Serta Zipper-Covered Foam Core Mattresses

Units: About 6,100

Manufacturer: Serta International Mattress Co., of Hoffman Estates, Ill.

Hazard: The mattresses fail to meet the mandatory federal open flame standard for mattresses, posing a fire hazard to consumers.

Incidents/Injuries: None reported.

Description: The recalled mattresses have a zipper cover over a foam core. The mattresses were sold in twin, full, queen, king and California king sizes. They were manufactured between November 30, 2007 and May 20, 2008. The mattress name, date of
manufacture, model, and serial numbers are located on label attached to the mattress. Only specific serial numbers are included in the recall. The recalled mattresses are listed in the chart below.
Mattress Name Model Number Serial Number
Serene Signature Zip 810098, 810298,
810198, 810598

Contact Serta to determine if your serial number is included in the recall.
Accord Zip 830098
Perpetual Zip 830298, 830498
Solara Zip 830798
Solara II Zip 830898
Compass Zip 830198, 831598
Bellbrook Zip 830398
Elysian Zip 830698
Allington Zip 831098
Araceli Zip 831498
Royce Select Zip 831698



Manufactured in: United States

Remedy: Consumers should immediately contact Serta to determine if their mattress is included in the recall, and if it is, to receive a free replacement mattress cover. Consumers can install the cover themselves or request free installation by a
qualified repair technician.

Consumer Contact: For additional information, contact Serta toll-free at (866) 675-3853