Popular pain relievers are getting a new warning from the FDA. And, it’s not just the opioid class of pain relievers under fire. Non-steroidal anti-inflammatory drugs, or NSAIDs, are set to get a more stringent heart safety and stroke warning label.

Prescription medications such as Celebrex will get the warning labels first, but the FDA has plans to require over-the-counter drugs to include the warning as well. Popular drugs like Motrin and Advil, both NSAIDs, are a part of the FDA’s plans.

And to think, I just took some Motrin this morning…

The agency posted the announcement on its website to warn consumers. “In general, patients with heart disease or risk factors for it have a greater likelihood of heart attack or stroke.”

What do you need to know? The risk of a heart attack or stroke normally occurs within the first few weeks of starting the drug. Patients on higher doses of NSAIDs also have greater risk factors. I think we have someone in our life that says they just took a handful of Motrin. Yeah, not a good idea.

Why the change? It’s part of a now decade-old pain reliever safety review by the FDA and the result of internal and outside recommendations to the regulatory agency.

All of the labeling changes are a result of the Vioxx controversy in 2004. Merck had to pull the drug off the market after growing heart attack and stroke concerns. The only prescription drug left in the same class is Celebrex.

Vioxx was marketed as an NSAID that was easier on the stomach, a common side effect of high-dose anti-inflammatory drugs. Instead, heart and stroke concerns quickly emerged, shaking both the medical community and the FDA. Relentless advertising had exposed millions to potentially deadly side effects.

NSAID warning labels from FDA

In response, the FDA ordered a boxed warning on all prescription NSAIDs in 2005. It included Celebrex, high-dose ibuprofen (Motrin) and naproxen.

The current language on the pills says it can increase the risk of heart-related problems if used long-term.

None of this means you shouldn’t take the medication prescribed by your doctor. What it does show is you should be an educated patient. If you need to get your MD from WebMD, do it. Who gives a damn if it annoys medical professionals? We pay enough for health insurance. Might as well learn something.

Chronic pain sufferers should talk with their doctor to judge if any changes need to be made to treat their specific condition. It comes down to risk vs. pain management.

Also, when you hit the pharmacy section of the store to grab Motrin or any NSAID, be aware of the warnings. You shouldn’t be taking over-the-counter pain medication for more than ten days without seeing your primary care doctor.

Once the aches and pains go away, start moving around. It’s a repeated mantra, but just exercising and eating better will help keep the pills away.


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