The Food and Drug Administration is strengthening its warnings about painkillers like ibuprofen, saying they do raise the risk of heart attack or stroke.
People should think carefully about taking these drugs, both over-the-counter versions and prescription pills, the FDA says. It's asking manufacturers to change the labels.
"They used to say they might cause risk of heart attack or stroke. Now we are saying they do cause increased risk of heart attack and stroke," FDA spokesman Eric Pahon told NBC News.
The warning covers drugs called nonsteroidal anti-inflammatory drugs or NSAIDS for short. They include ibuprofen, sold under brand names like Advil or Motrin; naproxen (Aleve), as well as prescription arthritis drugs known as COX-2 inhibitors, such as Celebrex. Tylenol, known generically as acetaminophen, is not an NSAID.
Cough and cold remedies can also contain NSAIDs as an ingredient.
"Because many prescription and OTC medicines contain NSAIDs, consumers should avoid taking multiple remedies with the same active ingredient," the FDA said.
"FDA is strengthening an existing warning in prescription drug labels and over-the-counter (OTC) Drug Facts labels to indicate that nonsteroidal anti-inflammatory drugs (NSAIDs) can increase the chance of a heart attack or stroke, either of which can lead to death," the agency said in a statement.