FDA calls for heart attack risk update on painkiller labels

FDA calls for heart attack risk update on painkiller labels

The US Food and Drug Administration (FDA) is asking drug manufacturers to make changes in their warning labels on popular pain killers because some safety issues have appeared regarding their usage. Non-aspirin nonsteroidal anti-inflammatory drugs, NSAID's, are now required to have updated labels to clearly show that they could increase risk of a heart attack or stroke.

The update is required for both over-the-counter strengths and higher doses that could only be purchased by showing prescription. The update warning is for all brands, including Celebrex, Advil, Naprosyn, Aleve and Daypro.

The FDA has said that the risk of a heart attack or stroke could occur as early as the first weeks of using an NSAID. The longer use of the NSAID can further increase the risk. The hearth attack risk is higher for people who have heart diseases, though the risk is not limited only to heart patients.

"We are committed to patient safety, and we will work with the FDA to make sure that new safety information is appropriately added to our packaging/drug facts label so that consumers can continue to safely use our products", said Pfizer (manufacturer of Celebrex and Advil) in a statement in reaction to the new recommendations.

Dr. Steven Nissen, chief of cardiovascular medicine at the Cleveland Clinic, says the FDA has made the right move because a patient's risk for heart attack and stroke can be increased by taking these medications. However, he said, the FDA should provide more information behind these warnings.