FDA Bolsters Stroke, Heart Attack Warning for NSAIDS

The U.S Food and Drug Administration recently strengthened the warning labels for widely used painkillers like ibuprofen and naproxen, saying they can increase the risk of heart attack or stroke.

The popular drugs, which are available by prescription or over the counter, are commonly used to relieve pain or reduce fever.

Yes, a few cough and cold medicines, as well as children’s medications are NSAIDS. New labels, however, will make the link explicit, stating that they “cause an increased risk” of heart attack and stroke.

Aspirin is the safer choice for the millions of people who take over-the-counter pain relievers like Advil or Aleve to deal with headaches or arthritis, a top cardiologist says.

“What this highlights is that everybody is at risk”, she said.

The agency will also require OTC NSAIDs to have updated information about the risk, which should appear in the “Drug Facts” labels. He blames this on the drugs being approved before current vigorous outcome data was required by the FDA.

Ibuprofen and other NSAIDs work by inhibiting production of prostaglandins-(by inhibiting an enzyme called cyclooxygenase). Common brands include Advil, Motrin, Aleve and Celebrex.

“People who take these drugs to deal with the pain from inflammation need to realize that these medications are not safe for daily use”, Chauncey Crandall, M.D., tells Newsmax Health.

In the meantime, Nissen says the best advice for patients is “take these at the lowest dosages for the least amount of time that relieves symptoms”.

As always, physicians and patients are asked to report adverse effects linked to NSAID use to MedWatch, (www.accessdata.fda.gov) the FDA Safety Information and Adverse Event Reporting Program. “And the problem is that people don’t really use it as the label states”, said Narula. “People don’t think of these as being risky”.

“These medicines have a long history of safety and efficacy when used as directed”, said the Consumer Healthcare Products Association, which represents nonprescription drugmakers, in a statement.

The agency said it is taking this action based on recent data that show the risk of heart attack or stroke can increase even after using NSAIDs for a short time.

While aspirin is safer than other NSAIDs, there are alternative ways to deal with chronic pain, as reported by Dr. Crandall.

For the last several years, the FDA has warned that ibuprofen, Naproxen and other NSAID-type painkillers may cause an increased risk for heart disease and stroke. FDA had already placed information regarding the risks of many OTC and prescription NSAIDs. “Now we are saying they do cause increased risk of heart attack and stroke”, FDA spokesman Eric Pahon told NBC News.

Prescribers should note that the relative increase in serious cardiovascular thrombotic events over baseline conferred by NSAID use appears to be similar in patients with and without known cardiovascular disease or risk factors for disease. The risk may increase with longer use of the NSAID.

The FDA recommends any patients who have new symptoms of chest pain, trouble breathing, weakness on one side of the body or slurred speech, while taking an NSAID, should contact a doctor.