FDA strengthens NSAID label warnings for heart attack, stroke risk

Based on a review of new safety information, the Food and Drug Administration yesterday announced it is strengthening an existing label warning that non-aspirin nonsteroidal anti-inflammatory drugs (NSAIDs) increase the chance of a heart attack or stroke. Available by prescription and over the counter, the drugs are used to treat pain and fever from common conditions such as arthritis and flu. Examples of NSAIDs include ibuprofen, naproxen, diclofenac and celecoxib. “Estimates of increased risk range from 10% to 50% or more, depending on the drugs and the doses studied,” the agency said. “This risk may occur as early as the first weeks of treatment and may increase with duration of use.” FDA encourages health care professionals and patients to report adverse events or side effects related to the use of these products to the agency’s MedWatch program.