WASHINGTON — The Food and Drug Administration is strengthening warnings on painkillers like ibuprofen to say that they cause an increased risk of heart attack and stroke. The over-the-counter forms include Advil, Motrin IB and Aleve.
The distinction was subtle: The labels already say such drugs "may cause" increased risk of heart attack and stroke. But the agency said that new data from a recent analysis provided stronger evidence of the increased risk of heart failure from such drugs, called nonaspirin nonsteroidal anti-inflammatory drugs (Nsaids), which are taken by millions of Americans.
In the coming months, the agency said it would ask manufacturers to change the labels to say that the drugs "cause an increased risk" of serious heart failure. It also will ask them to add that the risk may occur early in treatment and may increase the longer the patient uses the medicine.