A new study has found that Aleve, a popular over-the-counter painkiller made by Bayer, could increase heart problems, and federal officials are warning patients not to exceed the recommended dose of two 200-milligram pills a day or continue therapy for more than 10 days without consulting a physician.
It was the fourth big-selling pain medicine in recent months to be suspected of hurting the heart, and federal drug officials said that similar drugs, like Advil, might also increase heart risks.
The study, sponsored by the National Institutes of Health, was intended to measure whether Aleve and Celebrex, made by Pfizer, might prevent Alzheimer's disease. Nearly 2,500 patients were given one of the two drugs or a placebo and were followed for three years. Those taking Aleve had a 50 percent greater rate of heart problems - including heart attacks and stroke - than those given a placebo. The Celebrex patients saw no increase in heart events.
The latest findings follow an announcement Friday that a different national study found that those given high doses of Celebrex had a 240 percent increase in heart problems, including death. Merck executives withdrew their painkiller Vioxx after a study found that it increased the risk of heart attack and stroke by more than 100 percent. Also, Pfizer announced recently that a study of Bextra found that it increased the risk of heart attacks in those who have had cardiac surgery.
"This illustrates the fundamental dynamic that all drugs have risks," said Dr. Steven Galson, acting director of the Food and Drug Administration's center for drug evaluation and research. "All should be taken carefully."
Federal drug officials said that the entire class of painkillers known as nonsteroidal anti-inflammatories - drugs that include Celebrex, Advil and Mobic - could cause worrisome effects on the heart. Sales of Celebrex, along with other anti-inflammatories like Advil and Mobic, are expected to fall as a result.
"We know that there are other phenomena that occur across these class of drugs, including gastrointestinal bleeding," said Dr. Sandra Kweder, deputy director of the F.D.A.'s office of new drugs. Heart problems "may be another class phenomenon."
Dr. Kweder said that the agency was studying the results of this latest study and "will be assessing what regulatory actions are appropriate over the next day or two." Researchers stopped the study, but patients will be monitored. Link
Seriously, did we really just learn that "All drugs have risks"? Though it is good of the FDA to do so much to quell the panic that we've all now seen on TV and Radio. Hopefully, everyone will flock to Tylenol --the only over-the-counter non-NSAID (its more properly an analgesic)-- and start killing their livers to avoid heart attacks.
These latest revelations do highlight some serious ethical issues about how the FDA tests and approves drugs (in particular how they deal with drugs taken daily for years), but the public reaction does strike me as overblown.