‘Aspirin with supplements’ illegal and harmful: FDA

Washington, October 29: U.S. regulators warned on Tuesday that tablets made by Bayer AG and being sold under the aspirin brand name are being sold illegitimately and could do more harm than good to the consumers.

Till date, the main known undesirable side effects of aspirin were gastrointestinal, ulcers and stomach bleeding, and tinnitus.

Bayer AG, headquartered in Leverkusen, North Rhine-Westphalia, Germany is a chemical and pharmaceutical company founded in 1863. Today it is well-known for its original brand of aspirin. The products under fire are Bayer Women's Low Dose Aspirin plus Calcium and Bayer Aspirin with Heart Advantage which claim to fight osteoporosis and high cholesterol.

The Food and Drug Administration has also sent warning letters to the company. Michael A. Chappell, an FDA associate commissioner warned, “The F.D.A. will take enforcement action against manufacturers found to be violating the law or attempting to circumvent the drug approval process.”

Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research said, "The marketing of these unapproved drugs is troubling. The overuse or misuse of these aspirin-containing products can put consumers at risk for internal bleeding and other adverse events."

Aspirin, or acetylsalicylic acid is a salicylate drug, often used as an analgesic to relieve minor aches and pains, as an antipyretic to reduce fever, and as an anti-inflammatory medication. Aspirin is known to have an antiplatelet or "anti-clotting" effect and is used in long-term, low doses to prevent heart attacks, strokes and blood clot formation in people at high risk for developing blood clots.

Bayer backed its claims on both the products. The company said in a statement, "All of our communication on product benefits prominently features information for consumers to check with their physicians to determine if the product is right for them." The company intends to reply to the FDA warning letters in the next 15 business days.