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FDA: Painkiller Warnings Unclear

Sep 20, 2002 | AP

Aspirin, ibuprofen and other anti-inflammatory painkillers sold without a prescription should bear clearer warnings that bleeding ulcers are a possible side effect, government advisers recommended Friday.

The decision by the Food and Drug Administration's scientific advisers came as the agency examines the wording of package warnings of over-the-counter painkillers to ensure all their side effects are explained adequately. On Thursday, the panel said acetaminophen bottles should bear warnings that unintentional overdoses can cause serious liver damage.

Aspirin, ibuprofen and other painkillers known as NSAIDs, nonsteroidal anti-inflammatory drugs carry a different risk: They can cause ulcers and gastrointestinal bleeding, particularly in patients who take high doses for long periods. All prescription-strength NSAIDs carry explicit warnings about that risk, but warnings aren't so clear on lower-dose, over-the-counter versions.

FDA's advisers said Friday that people over age 65, those taking steroid medications or blood thinners, who have a histories of ulcers or stomach bleeding or who take more than one NSAID are at particular risk of developing ulcers. The advisers also said the nonprescription products should specifically mention gastrointestinal bleeding as a side effect.

The panel said people over 65, who have high blood pressure, heart failure or kidney or liver disease seem at higher risk for kidney damage, another, less common, NSAID side effect. The panel said product labels should somehow reflect that, perhaps by urging such people to consult doctors about NSAID use, FDA's Dr. John Jenkins said.

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