Over-the-Counter Drugs May Get Stronger Warnings

December 2006

The Food and Drug Administration (FDA) proposed stronger warning labels for over-the-counter drugs that are more dangerous than previously indicated. Labels will include warnings about liver failure resulting from overuse of acetaminophens and gastrointestinal bleeding from overuse of nonsteroidal anti-inflammatories (NSAIDS).

Over 200 million Americans a year take acetaminophens such as Tylenol, and more than 200 deaths occur because patients take too much medication or combine multiple medications with the drug. The proposed rule would have prominent warning labels indicating acetaminophen overdoses can cause liver failure and that the drug should not be taken if three or more drinks containing alcohol were consumed.

Additionally, painkillers known as NSAIDS, including aspirin, ibuprofen, ketoprofen and naproxen, will have label warnings about gastrointestinal bleeding. A study found that for every 100,000 patients taking the drugs, 15 deaths occur. The dangers rise in those over 60 who have ulcers and other stomach issues, those taking steroids or blood thinners, people who consume three or more alcoholic beverages a day, and those who take more than one product containing NSAIDS.

The FDA proposal will take up to a year to enact, but companies are updating their labels before the rule is finalized.

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