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Pain Management Health Center
This article is from the WebMD News Archive
Vioxx's Fall No Surprise to Some Doctors
Oct. 21, 2004 - Earlier this month, drug manufacturer Merck stunned the medical world when it announced it would pull the popular painkiller Vioxx off the market. The decision was based on clinical trial results showing that Vioxx doubles a patient's risks of heart attack and stroke. That risk is small, but with 2 million people taking the drug, it means a lot of heart disease.
Merck's sudden action may have been a shock. But some experts familiar with Vioxx research tell WebMD that they have been suspicious of the drug's heart side effects for years.
"The cardiology community has known of this for four years now," Muhammad Mamdani, PharmD, MPH, tells WebMD. Mamdani heads the drug research group at the Institute for Clinical Evaluative Sciences and is an associate professor at the University of Toronto, Ontario. He has done extensive research on heart disease and Cox-2 inhibitors, the group of drugs that Vioxx belongs to.
Carl Lavie, MD, isn't surprised either. Lavie is medical co-director of cardiac rehabilitation and preventive cardiology at New Orleans' Ochsner Clinic Foundation.
"I have been taking heart patients off Vioxx for three or four years," Lavie tells WebMD. "I see many patients with heart disease given Vioxx by rheumatologists and other doctors. I tell them it's better to take ibuprofen or naproxen."
That's the advice of a heart expert. But what do arthritis doctors say? WebMD asked Lavie's rheumatology counterpart -- Stephen M. Lindsey, MD, head of rheumatology at Ochsner's Baton Rouge facility.
"We are telling people to not get too hysterical," Lindsey tells WebMD. "It's not that everybody taking Vioxx is going to keel over. It was actually a small number of patients. If the risk of heart attack is 1 in 1,000 and increases to 2 in 1,000, it is still a pretty rare event. So we explain even though risk is increased, it is still a rare event. It was used in millions and millions of people."
So if doctors saw this coming, why did it take five years to pull Vioxx off the market?
"There will be a lot of angry consumers, a lot of angry researchers -- a lot of angry people in general saying why did it take so long to take Vioxx off the market," Mamdani says. "But to make a big decision about a drug that affects so many people's lives, and with so much money at stake -- $2.6 billion -- you do need more information. When we make decisions like this, we need lots of evidence from many directions to say something really is going on. Should that have occurred faster? Yes. But much faster? I am not so sure."
What About Other Cox-2 Drugs?
Cox-2 inhibitor drugs like Vioxx should never be used to prevent heart disease. That's what aspirin is for, Michael E. Farkouh, MD, says. But people getting pain relief from the other U.S.-approved Cox-2 inhibitors -- Bextra and Celebrex -- don't have to stop. Farkouh is associate director of the NYU cardiovascular clinical research center and an expert on the heart side effects of Cox-2 inhibitors.
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