FDA Will Strengthen Painkiller Warning Labels

The US Food and Drug Administration (FDA) will require manufacturers to update labels in order to red flag possible serious side effects associated with non-steroidal anti-inflammatory drugs (NSAIDs).

The US Food and Drug Administration (FDA) will require manufacturers to update labels in order to red flag possible serious side effects associated with non-steroidal anti-inflammatory drugs (NSAIDs).

NSAIDs (ibuprofen, naproxen, diclofenac, and celecoxib) are often used to treat pain and reduce fevers. Both prescription and over-the-counter NSAIDs labels draw attention to potential heart attack and stroke risk, but new requirements being enforced within months will make those warnings more specific. Additionally, the Drug Facts labels will also be updated to include heart attack and stroke risk.

“There is not period of use shown to be without risk,” Judy Racoosin, MD, MPH, deputy director of FDA’s Division of Anesthesia, Analgesia, and Addiction Products, said in a news release.

Patients with cardiovascular disease, especially those with history of heart attack or cardiac bypass surgery, have the greatest risk of experiencing the side effects and the new labels will provide information for those specific people. However, everyone is at risk regardless of medical history. Heart attack and stroke associated with the medication can happen as soon as the first few weeks of use.

“Consumers should carefully consider whether the drug is right for them, and use the medicine only as directed,” said Karen M. Mahoney, deputy director of FDA’s Division of Nonprescription Drug Products. “Take the lowest effective dose for the shortest amount of time possible.”

Furthermore, lifestyle factors and other conditions — such as smoking, high blood pressure, high cholesterol, and diabetes – can increase the risk of the serious side effects.

“If you smoke, work on quitting,” Mahoney advised. “See your doctor regularly to find out if you have these other strong risk factors, and commit yourself to taking care of them and of your health.”