Bayer HealthCare Illegally Markets Unapproved Drugs

Amanda Wick — Tue, 28 Oct 2008 15:42:41 GMT

Today the U.S. Food and Drug Administration sent Warning Letters to Bayer HealthCare regarding two aspirin products. According to the FDA, Bayer has illegally marketed two over the counter products: Bayer Women’s Low Dose Aspirin and Bayer Aspirin with Heart Advantage.

Both products contain aspirin plus either phytosterols or calcium and are unapproved new drugs. ”New drugs” must be approved by the FDA through a new drug application in order to be legally marketed.

These tablets are also a combination of a drug and a dietary supplement. When these two functions are combined into a single tablet, the product is considered a drug and is regulated by the FDA. Because the FDA considers these products new drugs, they must undergo the FDA’s drug approval process before they can be marketed and sold over the counter.

Before these products receive FDA approval, they must meet a number of different requirements. First, the drugs must be approved for all uses. This includes any secondary uses such as reducing the risk of heart disease and fighting osteoporosis, as these drugs claim to do. Second, they must also contain clear directions that can be followed by consumers without guidance by a health care professional.

Janet Woodcock, M.D., director of FDA’s Center for Drug Evaluation and Research, said that “[because over the counter] drugs are widely used by consumers, without the 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, people who took these drugs while they were on the market may suffer adverse side effects. If you haven taken these drugs and suffered adverse side effects, you should seek medical care and discuss the situation with your doctor.

Originally posted at InjuryBoard by Amanda Wick

Columbia Personal Injury Lawyer - aspirin

Bayer HealthCare Illegally Markets Unapproved Drugs