The Food and Drug Administration (FDA) looked at 350,000 patients taking pain relievers and discovered one ingredient stands out for its heart safety, naproxen.
In a memo released Tuesday by the FDA, an advisory committee said it recommended a new label for pain relievers with naproxen, including Aleve, saying "there is now credible evidence that naproxen carries a lower cardiovascular risk" than other drugs in that category. The advisory committee was made up of doctors and outside experts.
CBS News’ contributor Dr. David Agus joined “CBS This Morning” to discuss why naproxen makes those drugs safer. Agus told the co-hosts that this new recommendation stems from a 2004 clinical trial that showed the drugs Vioxx and Celebrex had an increased heart attack risk.
“Vioxx was pulled from the market and they showed it was in the same in the other class, like the Motrins, the Advils and the naproxen,” he said. “Now with 350,000 patients looked at, Naproxen doesn’t seem to have the heart attack risk of the others.”
Agus said that although naproxen was initially part of “a warning on a whole class of drugs,” researchers can now look at the “big data,” to weigh the danger of each individual pain reliever. The warning was for the class of drugs known as nonsteroidal anti-inflammatory drugs, or NSAIDs.
“Naproxen isn’t as risky as the others. People need to take pain meds, so this appears to be the safe one,” he said.
Agus said what makes naproxen different than similar drugs in the category is that it does not cause “increased clotting that can get into the heart and cause heart attacks.”
However, he said that pain relievers without naproxen will not cause a problem if you’re taking a low dose for a couple of days and the warning really applies to “chronic use, especially at the higher doses.”
“People with existing heart problems, really should switch or consider the naproxen and have a discussion with your doctor,” he said. “Next week, or in two weeks there’s going to be a meeting of the FDA panel – the outside panel – that will review this data and make final conclusions that the FDA may or may not accept.”