Aleve

A Fourth Painkiller Is Linked to Increases in Heart Problems

The headline carries much greater drama than the study.

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.

We now have full blown hysteria concerning anti-inflammatory drugs and heart disease. The press has a feeding frenzy. Careful reasoned debate takes a backseat.

“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.

So caution is in order. But then caution should always be in order when you take OTC drugs, prescribed drugs or “dietary supplements”. Every chemical of which I am aware can cause problems – even water. The problems can come from dose effects, side effects or interactions.

As a rule, I take very few OTC medications. I would rather take a nap when I have a mild headache than try to mask the pain with an OTC drug. I often take no medications when I have a cold – unless the drainage makes working or sleeping too difficult. Then I only take the medication for a very short amount of time.

“I’ve been saying for a long time that over-the-counter Nsaid’s are extraordinarily dangerous,” said Dr. Mark Fendrick, professor of internal medicine at the University of Michigan. Nsaid refers to nonsteroidal anti-inflammatories, which include Aleve, Advil and Mobic.

Many critics of the drug industry say that the industry has used widespread advertising to sell medicines to more patients than need them. Drug makers make more than half of their sales and the majority of their profits in the United States and drug side effects are one of the leading causes of deaths in this country, critics say.

The one drug that is known to protect the heart is aspirin, Dr. Fendrick said. All other painkillers are now under suspicion, he said.

But Dr. Garret FitzGerald, chairman of the University of Pennsylvania’s pharmacology department and the first to speculate that drugs like Celebrex and Vioxx could be uniquely hurtful to the heart, said he simply did not believe the announcement.

The heart problems found in the study have not been examined by a panel of heart experts or statisticians, Dr. FitzGerald noted. Such a vetting could change the results substantially, he said.

This finding might be a probabilistic anomaly. We do not even know if the results are statistically significant.

How should this news release change your behavior? How should this news release change the FDA?

I recommend using all OTC drugs with caution. If you believe that you should take something for a prolonged time, please discuss the indication for the drug with your physician. He (or she) will consider that drug in the context of your medical problems and other drugs.

I hope all physicians will magnify their efforts to use the fewest drugs for each patient. Often I have patients admitted to my service who are taking too many drugs. We should always work towards parsimony in our prescribing.

The FDA cannot let these issues change their policies on approving new drugs for serious conditions. We had a wonderful Grand Rounds at UAB last week discussing new HIV drugs. The speaker made the point that the FDA has done a wonderful job in speeding up the approval process for HIV drugs. He cautioned (and I agree entirely) that problems with Vioxx and Celebrex should not change policy for HIV drugs or cancer drugs.

All medications have risks and benefits. Non-steroidal anti-inflammatory drugs help some patients greatly. I would even favor continuing limited access to Vioxx and Celebrex. Patients would need to understand the risks. Some patients have their quality of life improved so greatly from these drugs, that the risk makes sense. Let the patient and the physician make this decision with a full understanding of the risks. We do this everyday for many medications.