FDA Strengthens Heart Safety Warnings on Painkillers

FDA Strengthens Heart Safety Warnings on Painkillers

The Food and Drug Administration is strengthening its warnings about painkillers like ibuprofen, saying they do raise the risk of heart attack or stroke. People should think carefully about taking these drugs, both over-the-counter versions and prescription pills, the FDA says. It's asking manufacturers to change the labels. The FDA spokesperson, Eric Pahon, is now saying that these painkillers do cause increased risk of heart attack and stroke. The painkillers include nonsteroidal anti-inflammatory drugs or NSAIDS, including ibuprofen, sold under brand names like Advil or Motrin; naproxen (Aleve), as well as prescription arthritis drugs known as COX-2 inhibitors, such as Celebrex. Tylenol, known generically as acetaminophen, is not an NSAID.

Not only does ibuprofen directly raise the risk of heart attack and stroke, but many cough and cold remedies which also contain NSAIDs as an ingredient can raise the risk as well. "Because many prescription and OTC medicines contain NSAIDs, consumers should avoid taking multiple remedies with the same active ingredient," the FDA said. "FDA is strengthening an existing warning in prescription drug labels and over-the-counter (OTC) Drug Facts labels to indicate that nonsteroidal anti-inflammatory drugs (NSAIDs) can increase the chance of a heart attack or stroke, either of which can lead to death," the agency said in a statement.

"Those serious side effects can occur as early as the first few weeks of using an NSAID, and the risk might rise the longer people take NSAIDs. (Although aspirin is also an NSAID, this revised warning doesn't apply to aspirin.)" "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.

"In the coming months, the FDA will request that manufacturers update the existing cardiovascular risk information in Drug Facts labels for over-the-counter (OTC) non-aspirin NSAIDs. Consumers and health care professionals should remain alert for the development of heart- and stroke-related symptoms throughout the time a consumer takes any NSAID," FDA said. This doesn't mean people should just stop taking NSAIDS, FDA said.

"Take the lowest effective dose for the shortest amount of time possible," said FDA's Dr. Karen Mahoney. The American Heart Association advises people to try acetaminophen (Tylenol) first. "If you have heart disease or high blood pressure, consult a health care provider before using an NSAID," FDA added. "Balance the benefits of NSAIDs with the possible risks and weigh your options. If you take low-dose aspirin for protection against heart attack and stroke, you should know that some NSAIDs, including ibuprofen and naproxen, can interfere with that protective effect."

"Stop taking NSAIDs and seek medical help if you experience symptoms that might signal heart problems or stroke, such as chest pain, trouble breathing, sudden weakness in one part or side of the body, or sudden slurred speech."

In 2013 Americans bought more than 275 million boxes of over-the-counter NSAIDs, racking up $1.7 billion in sales, according to retail tracker IRI.
For more information, http://www.nbcnews.com/health/heart-health/fda-strengthens-heart-safety-... will send you to a link of possible medications which raise your risks of heart attack and/or stroke.

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