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:10/13/2017)... ... ... The Visiting Nurse Association (VNA) of Somerset Hills is proud to host ... items from across the nation, this holiday-themed event will raise funds and awareness for ... The boutique will be open Saturday, November 4 (10:00 a.m. – 5:00 p.m.) ...
(Date:10/13/2017)... ... , ... Talented host, actor Rob Lowe, is introducing a ... episode of "Success Files," which is an award-winning educational program broadcasted on PBS ... in-depth with passion and integrity. , Sciatica occurs when the sciatic nerve in ...
(Date:10/12/2017)... ... October 12, 2017 , ... ... healthcare compliance program management, will showcase a range of technology and learning solutions ... Living (NCAL) Convention and Expo to be held October 14–18, 2017 at the ...
(Date:10/12/2017)... ... October 12, 2017 , ... IsoComforter, Inc. ( https://isocomforter.com ... introduction of an innovative new design of the shoulder pad. The shoulder pad ... comfort while controlling your pain while using cold therapy. By utilizing ice and water ...
(Date:10/12/2017)... , ... October 12, 2017 , ... ... Hair Restoration, has recently contributed a medical article to the newly revamped ... Dr. Mohebi’s article spotlights the hair transplant procedure known as Follicular Unit ...
Breaking Medicine News(10 mins):
(Date:10/11/2017)... -- Hill-Rom Holdings, Inc. ("Hill-Rom") (NYSE: HRC), today provided an ... Puerto Rico , where the company ... Following a comprehensive onsite assessment, ... damage, temporary loss of power and minimal water damage ... operations have resumed, and the company expects to return ...
(Date:10/10/2017)... --  West Pharmaceutical Services, Inc. (NYSE: WST), a ... today shared the results of a study highlighting the ... administration of polio vaccines. The study results were presented ... by Dr. Ondrej Mach , Clinical Trials and ... and recently published in the journal Vaccine. i ...
(Date:10/5/2017)...  In response to the nationwide opioid epidemic, ... (AAOMS) released prescribing recommendations that urge ibuprofen – ... a first-line therapy to manage a patient,s acute ... Recognizing the value and importance of the ... Acute and Postoperative Pain Management" stresses that practitioners ...
Breaking Medicine Technology: