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FDA Bolsters Stroke, Heart Attack Warning for NSAIDS

Tylenol also has potential health risks and this includes liver damage and toxicity when taken in very high doses.

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The FDA is requiring manufacturers to change labels to strengthen the warnings on painkillers, like ibuprofen.

FDA officials announced in a July 9 Drug Safety Communication(www.fda.gov) that the agency is directing manufacturers of all non-aspirin nonsteroidal anti-inflammatory drugs (NSAIDs) to update their product labels to clearly indicate these analgesic medications increase users’ risk for cardiovascular thrombotic events, including myocardial infarction and stroke. They include 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. The agency recommends that they should be used only in case of emergency for short periods of time. The team noted that they have “extremely solid” evidence to back the link between the said pain killers and stroke and heart failure risk.

The information is a bit unclear, as we are not advised abut which drug is safer compared to others, or whether there is a safe minimum dose or minimum duration of exposure, or whether some communities might be less vulnerable. “People don’t think of these as being unsafe”.

“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. They also state that while risk increases the longer the drugs are taken, people can suffer a heart attack or stroke in the first few weeks of use.

The news is another blow to what have been considered common, safe and mild over the counter pain medications. It is unclear from the available data whether the risk for these events is similar for all non-aspirin NSAIDs, but the increased risk is observed most consistently at higher doses. “Now we are saying they do cause increased risk of heart attack and stroke”, FDA spokesman Eric Pahon told NBC News. The FDA says there is not sufficient evidence to determine whether the risk is the same for all NSAIDs.

Federal health regulators are bolstering warning labels for popular pain relievers, adding information about the risk of heart attack and stroke in the short term. Even more concerning, a 2014 study found that deaths associated with strokes were 19 percent higher in patients who had been taking NSAIDs. For instance, over-the-counter medications could boost risk up to 20 percent. If you take these drugs, take the smallest effective dose.

The risk is greatest for people who already have heart disease, though even people without heart disease may be at risk.

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Seek urgent medical attention and stop taking NSAIDs if you experience symptoms that might signal heart problems or stroke – chest pain, trouble breathing, sudden weakness in one part or side of the body, or sudden slurred speech.

Over-the-Counter Pain Killers May Hike Risk of Heart Attack and Stroke