The government Wednesday directed makers of prescription pain pills to add new warnings informing doctors that such drugs may increase the risk of life-threatening gastrointestinal problems such as ulcers.
The Food and Drug Administration announced that it had ordered manufacturers to add a warning citing studies that show that up to 4% of people who receive continued therapy with pain-relieving drugs may develop serious gastrointestinal reactions.
The side effects, which include peptic ulcers and intestinal perforation, sometimes occur in people without any warning symptoms, the FDA noted.
The prescription drugs in question are called non-steroidal anti-inflammatory drugs, or NSAIDs. They generally are considered safer than steroid treatments, which they have largely replaced, and often are essential in treating serious arthritis. Some are approved for pain and menstrual cramps also.
FDA data shows that the drugs are being prescribed for conditions, such as tendinitis, sprains or joint and muscle pain, that can be treated with other therapies bearing fewer side effects, according to the new labeling.
FDA Commissioner Frank E. Young urged doctors “to discuss with their patients the risks and benefits of using these drugs.”
The drugs for which the new labels are required include: Voltaren, Nalfon, Tolectin, Indocin, Dolobid, Meclomen, Feldene, Ponstel, Anaprox, Naprosyn, Orudis, Butazolidin, Rufen, Motrin, Ansaid and generic versions of ibuprofen, indomethacin and phenylbutazone.