WASHINGTON, Oct. 28 (Xinhua) -- The U.S. Food and Drug Administration (FDA) on Tuesday sent Warning Letters to Bayer HealthCare concerning two unlawful, over-the-counter aspirin products.
The products -- Bayer Women's Low Dose Aspirin + Calcium (Bayer Women's) and Bayer Aspirin with Heart Advantage (Bayer Heart Advantage) -- contain aspirin with either calcium or phytosterols. "They are unapproved new drugs that require an approved new drug application in order to be legally marketed," FDA said in a statement.
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," FDA warned.
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), according to FDA.
"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."
"The marketing of these unapproved drugs is troubling," said Janet Woodcock, 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.
Companies that do not resolve violations in FDA Warning Letters risk enforcement action, such as injunctions and/or seizure of illegal products, according to the statement.
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