F.D.A. Is Set to Toughen Nonaspirin Warnings July 16, 2015, 11:15

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.

The changes will apply to over-the-counter and prescription forms of the medicine, an F.D.A. spokesman said. The agency said people with heart problems should consult a doctor before taking the medication. The F.D.A. said it reviewed a large number of studies that supported the conclusion that the medicines caused increased risk. The studies estimated that the relative risk increased by 10 percent to 50 percent, depending on the drugs and the doses considered.

The agency first warned of the risk of heart attack and stroke in the prescription medicines in 2005. People who have heart disease, particularly those who recently had a heart attack or stroke, are most at risk, the agency said. But it added that even those who had never had heart disease were at risk.

«Everyone may be at risk, even people without an underlying risk for cardiovascular disease," Dr. Judy Racoosin, the deputy director of the F.D.A.’s Division of Anesthesia, Analgesia and Addiction Products, said in a written explanation of the change.

Last year, the F.D.A. convened a panel of experts to review the studies and evidence that informed its decision on Thursday.

The over-the-counter form of the drugs is used to treat pain or fever. The prescription forms tend to be stronger and are used to treat arthritis and other painful conditions, the agency said.

In a statement, the Consumer Healthcare Products Association, a trade association for makers of over-the-counter medicines, said such drugs «have a long history of safety and efficacy when used as directed," and that the current label already addresses heart risks «and directs consumers to take the smallest effective dose." It said it would work with the F.D.A. to make the changes it is requesting «to ensure continued safe consumer use.»

http://www.nytimes.com/2015/07/10/us/fda-is-set-to-toughen-nonaspirin-warnings.html?_r=0