FDA strengthens its warning about Motrin, Advil and Aleve

The Food and Drug Administration (FDA) has strengthened its existing warning that non-steroidal anti-inflammatory drugs like Motrin, Advil and Aleve can increase the chance of heart attack or stroke.

The over-the-counter drugs can cause serious side effects that can occur as early as the first few weeks of using the temporary pain relievers, the agency said.


Because a number of prescriptions and over-the-counter drugs contain non-steroidal anti-inflammatories, FDA is telling consumers to avoid taking multiple pain relievers with the same active ingredient.

In the coming months, the agency said it will require manufacturers of prescription non-steroidal anti-inflammatory drugs to update their labels with more specific information about heart attack and stroke risks.

The agency will also request that manufacturers of over-the-counter versions of the drugs update the heart attack and stroke risk information on their drug facts labels.

FDA, which first issued warnings for the prescription drugs in 2005, said updated information is needed because more recent data shows there’s a risk of heart attack and/or stroke occurring within the first few weeks of treatment.

“There is no period of use shown to be without risk,” Dr. Judy Racoosin, deputy director of FDA’s Division of Anesthesia, Analgesia and Addiction Products, said in a statement.

People who have cardiovascular disease, particularly those who recently had a heart attack or cardiac bypass surgery, are at the greatest risk.