FDA issues strongest warning ever about these popular OTC meds
It may be the most stunning about-face in FDA history.
For years the agency denied that nonsteroidal anti-inflammatory drugs (NSAIDs) — a popular class of OTC and prescription painkillers — were dangerous. They even claimed it was safe to pop the pills every single day.
And for years the FDA ignored troubling science linking these meds like ibuprofen (Motrin and Advil) and naproxen (Aleve) to hundreds of thousands of heart attacks and strokes.
But now even the FDA is claiming the evidence is too overwhelming to ignore. They’re demanding that these painkillers siting in millions of medicine cabinets and purses right now start carrying a label admitting they could kill you.
Even if you’re perfectly healthy. And even if you only take one pill.
That warning comes straight from Dr. Judy Racoosin, deputy director of the FDA division that oversees NSAIDs.
And it’s the FDA’s way of admitting that NSAIDs up your heart disease and stroke risk from the moment you take your first dose. And that includes cheap ibuprofen drugs that you can buy over the counter at any pharmacy in America.
I’ve been warning you about the serious — and immediate — heart dangers of NSAIDs for years. In fact, just last spring a study found using NSAID pain relievers increase your risk of A-fib, a potentially deadly heart rhythm, by a whopping 84 percent.
And that risk skyrocketed during the first 30 days of use.
And all the while the FDA sat on its hands and let ibuprofen, naproxen, and other NSAIDs become some of the top-selling drugs on America. They’re taken by millions of people a day who are totally unaware of the risks.
Now that’s starting to change. After years of pressure from consumer groups — and NSAID victims and their families — the FDA finally agreed to take a new look at the science behind the meds.
And what the agency found was so appalling that it’s forcing drug makers to change the labels on prescription and OTC NSAIDs to admit they can cause heart attacks and strokes.
In fact, here’s just a summary of what the FDA found in its review.
- These drugs can increase your risk of heart failure;
- Your chance of having a heart attack or stroke jumps quickly in the first week of taking an NSAID. The longer you take them and the higher the dose, the greater the danger;
- Even occasional users of NSAIDs have an increased risk of heart attack of stroke;
- Patients who were given NSAID drugs after a first heart attack were more likely to die within a year compared to those who didn’t take such medications.
NSAIDs pose the greatest risk to people who recently had a heart attack or bypass — which is especially alarming because many people pop pain relievers like candy after a surgery. But what may be most alarming is that even people with healthy hearts can be killed by the drugs.
“Everyone may be at risk — even people without an underlying risk for cardiovascular disease,” said Dr. Racoosin.
Along with the OTC drugs like Advil, Aleve and Motrin that I mentioned, many prescription meds are in the NSAID class as well. So you could easily be taking a massive dose without ever realizing it.
The most notorious prescription NSAID, of course, was Vioxx, which was pulled off the market in 2004. At the time, the low-ball estimate was that the drug had caused 139,000 heart attacks and killed 60,000 people.
But even though Vioxx is gone (thank goodness!), there are still other prescription NSAIDs like Celebrex that we’ve known for years are dangerous for your heart. Celebrex carries a black box warning claiming it can cause fatal heart attacks and strokes — but many other prescription NSAIDs don’t.
And such warnings have never been placed on OTC meds.
If you want to see if any of the drugs you’re taking right now are NSAIDs, here’s a good list from RxList.com.
Our government and the drug companies waited years to come clean about the risks of these meds. But you can protect yourself and your family from these deadly pills, starting today.
Sources:
“FDA strengthens heart attack, stroke warning for popular painkillers” Dennis Thompson, July 9, 2015, HealthDay, consumer.healthday.com
“FDA Drug Safety Communication: FDA strengthens warning that non-aspirin nonsteroidal anti-inflammatory drugs (NSAIDs) can cause heart attacks or strokes” FDA Safety Announcement, July 9, 2015, fda.gov
