Navigation Links
Bayer Marketing Two Unapproved Aspirin Products: FDA
Date:10/28/2008

Warning letters issued for Bayer Heart Advantage, Bayer Women's Low Dose Aspirin + Calcium

TUESDAY, Oct. 28 (HealthDay News) -- Drug giant Bayer HealthCare is illegally marketing two unapproved over-the-counter aspirin medications, the U.S. Food and Drug Administration said in warning letters issued Tuesday.

The products -- Bayer Women's Low Dose Aspirin + Calcium and Bayer Aspirin with Heart Advantage -- are unapproved new drugs that require an approved new drug application to be legally marketed, the FDA said. In addition to being labeled as pain relievers, both products claim to reduce the risk of heart disease. Bayer Women's also claims to fight osteoporosis. Neither product has been approved by the FDA for such uses.

Such uses require a health-care professional's diagnosis and supervision, and therefore Bayer Women's and Bayer Heart Advantage can't be labeled for use by consumers and sold over-the-counter, the agency explained.

Bayer Heart Advantage combines aspirin and phytosterols, which the label claims helps lower cholesterol levels. Bayer Women's combines aspirin and calcium carbonate.

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

In addition, the FDA said Bayer Women's and Bayer Heart Advantage has labeling that lacks adequate directions for use by consumers. This means that directions aren't written in a way that consumers can use the products safely for their intended purposes without the supervision of a health-care professional.

"The marketing of these unapproved drugs is troubling," Dr. Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research, said in the news release. "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."

FDA officials said they weren't aware of any significant adverse events associated with Bayer Women's or Bayer Heart Advantage.

If companies fail to resolve violations cited in FDA warning letters, they face enforcement action such as injunctions and/or seizure of illegal products.

More information

The FDA has more about its drug approval process.



-- Robert Preidt



SOURCE: U.S. Food and Drug Administration, news release, Oct. 28, 2008


'/>"/>
Copyright©2008 ScoutNews,LLC.
All rights reserved  

Related medicine news :

1. IVCC launches groundbreaking insecticide projects with Bayer and Syngenta
2. AUDIO from Medialink and Bayer: Simple, Focused Ways to Boost Womens Health
3. Bayer HealthCare Cleared to Acquire Citracal(R)
4. Genzyme and Bayer Schering Pharma AG, Germany to Present New Data on Alemtuzumab in Multiple Sclerosis at ECTRIMS
5. Bayer Foundation Grant Creates Graduate Engineering Fellowship at University of Houston
6. AUDIO from Medialink and Bayer: Is Your Pain Reliever Undermining Your Aspirin Therapy?
7. Bayer Temporarily Suspends Global Trasylol(R) Marketing
8. AUDIO from Medialink and Bayer: Lifesaving Benefits of Low-Dose Aspirin Therapy Maintained with Naproxen Sodium
9. Bayer Plants Trees With Chartiers Valley Intermediate School Students, Provides Free Environmental Education Materials
10. Bayer Awards Making Science Make Sense Grant to Girl Scouts
11. Bayer HealthCare Pharmaceuticals and MedAssets Supply Chain Systems Sign a Three-Year Agreement for Magnevist(R) Magnetic Resonance Contrast Media
Post Your Comments:
*Name:
*Comment:
*Email:
Related Image:
Bayer Marketing Two Unapproved Aspirin Products: FDA
(Date:4/21/2017)... Hong Kong (PRWEB) , ... April 21, 2017 , ... ... Printing (U3DP), the first 3D printing facility among higher education institutions in Hong Kong ... 3D printing, in terms of the range and quantity of facilities in Hong Kong. ...
(Date:4/21/2017)... ... April 21, 2017 , ... The ... A Week of Addiction and Recovery Education, from April 24 to April 28, ... substance use disorders. , The mission of AWARE is to instill a ...
(Date:4/21/2017)... ... April 21, 2017 , ... Airway Management, the ... with the highly regarded and well renowned Asian distributor, Discovery Sleep. ... PAP Nasal Pillow Mask, and will stabilize and strengthen Airway’s presence with a ...
(Date:4/21/2017)... (PRWEB) , ... April 21, 2017 , ... ... Enterprise in the category of International Trade, the UK’s most prestigious award for ... trade, which represents 95% of total revenues and has grown by a total ...
(Date:4/21/2017)... ... April 21, 2017 , ... Providing for loved ones before ... planning process, or where to even begin. “Now more than ever there are some ... properly protect yourself and your family,” said attorney Lisa Edgar Dickman, founder of the ...
Breaking Medicine News(10 mins):
(Date:4/19/2017)... , April 19, 2017 ... stimulate an immune response in pets such as ... products are of various types such as Attenuated ... Toxoid Vaccines, DNA Vaccines and Recombinant Vaccines. Attenuated ... as virus or bacteria, which have been weakend ...
(Date:4/18/2017)... Ohio , April 18, 2017  Cardinal Health ... Non-GAAP 1 fiscal 2017 earnings per share (EPS) ... and 2019.  This is in conjunction with this morning,s ... Deep Vein Thrombosis and Nutritional Insufficiency businesses. ... from continuing operations will be at the bottom of ...
(Date:4/18/2017)... April 18, 2017  Astute Medical, Inc., developer of ... to be presented at the 2017 National Kidney Foundation ... and continues through April 22. Physicians will present data ... to assess risk for acute kidney injury (AKI) during ... (ADHF). Elevated levels of TIMP-2 and ...
Breaking Medicine Technology: