Earlier this month, FDA announced it was requiring heightened warnings about heart attack and stroke risks on the labels of all non-aspirin, nonsteroidal anti-inflammatory drugs ("NSAIDs"), in prescription and over-the-counter form. The warning updates existing label information from a statement that NSAIDs "may cause" increased heart attack and stroke to a more conclusive statement that the drugs "cause an increased risk" of serious heart failure. The labeling revision comes from a comprehensive analysis of new safety information, including observational studies, combined analyses of clinical trials, other scientific publications, and the input of the Arthritis and Drug Safety and Risk Management Advisory Committees in early 2014.
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