FDA to Strengthen Safety Warnings for a Class of Common Pain Relievers

The Food and Drug Administration (FDA) is strengthening warnings on painkillers like ibuprofen. These drugs would need to mention that they cause an increased risk of heart attack and stroke.

It is known that the labels of common pain relievers such as Advil, Motrin IB and Aleve already include a warning that these drugs might increase the risk of heart attack and stroke. But the agency said a recent data provided stronger evidence that the increased risk of heart failure is linked to nonaspirin nonsteroidal anti-inflammatory drugs (Nsaids).

The agency said in a statement that it would ask the manufacturers of such drugs in coming months to change the labels. As per FDA's requirements the new labels must have a warning that the drugs cause an increased risk of serious heart failure.

FDA will also ask the manufacture to mention that the risk from drugs might occur early in treatment and might increase if the person uses it for longer duration.

An FDA spokesman said in a statement that these changes will apply to over-the-counter and prescription forms of the medicine.

FDA stated that people with heart problems should strictly consult a doctor before taking the medication. It also said that it has reviewed a large number of studies that supported the conclusion that the medicines caused increased risk.

The agency first warned of the risk of heart attack and stroke in the prescription medicines in 2005.

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