FDA seeks to strengthen heart warnings for NSAIDs
SILVER SPRING, Md. - The U.S. Food and Drug Administration last week strengthened an existing label warning that prescription non-aspirin nonsteroidal anti-inflammatory drugs (NSAIDs) increase the chance of a heart attack or stroke.
The agency is also seeking to update OTC labels, though OTC use is restricted in dosage and time of recommended use.
"Millions of consumers rely on OTC NSAIDs to relieve short-term pain and reduce fever, and these medicines have a long history of safety and efficacy when used as directed," the Consumer Healthcare Products Association released in a statement. "The current OTC label addresses potential cardiovascular risks and directs consumers to take the smallest effective dose."
The OTC Drug Facts Label advises consmers that OTC NSAIDs are not intended to be used for more than 10 days for pain (and 3 days for fever) unless directed by a physician.
Based on FDA's review, the prescription NSAID labels will be revised to reflect the following information:
The risk of heart attack or stroke can occur as early as the first weeks of using an NSAID. The risk may increase with longer use of the NSAID;
The risk appears greater at higher doses;It was previously thought that all NSAIDs may have a similar risk. Newer information makes it less clear that the risk for heart attack or stroke is similar for all NSAIDs. However, this newer information is not sufficient for us to determine that the risk of any particular NSAID is definitely higher or lower than that of any other particular NSAID;
NSAIDs can increase the risk of heart attack or stroke in patients with or without heart disease or risk factors for heart disease. A large number of studies support this finding, with varying estimates of how much the risk is increased, depending on the drugs and the doses studied;
In general, patients with heart disease or risk factors for it have a greater likelihood of heart attack or stroke following NSAID use than patients without these risk factors because they have a higher risk at baseline;
Patients treated with NSAIDs following a first heart attack were more likely to die in the first year after the heart attack compared to patients who were not treated with NSAIDs after their first heart attack; and
There is an increased risk of heart failure with NSAID use.
The agency will request similar updates to the existing heart attack and stroke risk information in the Drug Facts labels of OTC non-aspirin NSAIDs.
Examples of NSAIDs include ibuprofen, naproxen, diclofenac and celecoxib.