The Food and Drug Administration has announced that it is revising existing warnings for nonsteroidal anti-inflammatory drugs (NSAIDs) to indicate that they can increase the risk for heart attack or stroke. The agency published the announcement on the Consumer Updates page of the agency's website on Thursday.
The present warning labels for both prescription and over-the-counter NSAIDs already provide information for the risk of heart attack and stroke, but the FDA wants manufacturers to include more specific information about the said health risks especially for prescription NSAIDs.
"They used to say they might cause risk of heart attack or stroke. Now we are saying they do cause increased risk of heart attack and stroke," FDA spokesman Eric Pahon said, NBC News reported.
These risks may occur even in the early stages of treatment, according to the FDA.
"There is no period of use shown to be without risk," said Dr. Judy Racoosin, deputy director of FDA's Division of Anesthesia, Analgesia and Addiction Products. The risk of a heart attack and stroke can occur in just the first weeks of NSAID use, the FDA says.
Those with cardiovascular disease, as well those who had a recent heart attack or recent cardiac bypass surgery, face the greatest risk, which is why the new NSAID warning labels will include specific warnings for this group of consumers. However, the risk also applies to those who have not had previous cardiovascular problems.
"Everyone may be at risk - even people without an underlying risk for cardiovascular disease," Racoosin said.
The FDA added that the revised warning label for prescription NSAIDs will state that NSAID use increases the risk of heart failure and that higher doses of NSAID increases the risk of a heart attack or stroke. More information on the revised warning label for prescription NSAIDs can be found on the Drug Safety page of the FDA's website.
NSAIDs are used to treat pain, fever and inflammation. They are used for the relief of headaches, cold, flu, muscle aches, toothache, osteoarthritis, rheumatoid arthritis and other conditions. Common OTC NSAIDs include ibuprofen, naproxen, celecoxib and diclofenac.
With these new FDA warnings, what should consumers do?
Dr. Karen M. Mahoney, deputy director of FDA's Division of Nonprescription Drug Products, advised consumers to carefully read the Drug Facts label, especially for nonprescription drugs, and to use the medicine as directed, according to FDA's Consumer Updates page.
"Consumers should carefully consider whether the drug is right for them," Mahoney said.
She also said consumers should take the lowest effective dose for the shortest amount of time possible.
Those with heart disease or high blood pressure should consult their doctors first before taking NSAIDs. If chest pain, shortness of breath or slurred speech is experienced after taking NSAID, immediate medical attention should be sought.
Mahoney also reminded consumers to reduce their risk factors for heart disease.
"Smoking, high blood pressure, high cholesterol and diabetes are significant risk factors for these conditions," she said. "If you smoke, work on quitting. See your doctor regularly to find out if you have these other strong risk factors, and commit yourself to taking care of them and of your health."
The revised warning on NSAIDs does not apply to aspirin.
