June 27, 2005

The FDA has published an updated labeling template and medication guide for nonsteroidal anti-inflammatory drugs (NSAIDs) - a move that comes roughly two months after the agency requested manufacturers to include new risk information on labeling for the pain drugs.

The new "black-box" warning that will accompany all NSAIDs includes information on cardiovascular and gastrointestinal risks, according to the FDA, which released the new labeling information in mid-June. The black-box risk information reads as follows:

Cardiovascular: "NSAIDs may cause an increased risk of serious cardiovascular thrombotic events, myocardial infarction and stroke, which can be fatal. This risk may increase with duration of use. Patients with cardiovascular disease or risk factors for cardiovascular disease may be at greater risk."

Gastrointestinal: "NSAIDs cause an increased risk of serious gastrointestinal adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients are at greater risk for serious gastrointestinal events."

In addition to including the black-box warning on NSAID labeling, manufacturers will begin disseminating a medication guide with the pain drugs. The medication guide provides general safety information about NSAIDs, including possible side effects.