Merck pulling Vioxx over stroke, heart risk

By Newsday and Seattle Times staff

DANIEL HULSHIZER / AP An estimated 84 million Vioxx prescriptions were written since it was approved 1999. The FDA approved it for children two weeks ago.

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Related stories Merck stock plummets on news of Vioxx recall

Vioxx, the blockbuster arthritis drug dubbed at its debut as "super aspirin," was pulled from the market by its maker yesterday because the painkiller can double the risk of heart attacks and strokes.

The announcement by Merck shocked many in the medical community, sent the company's stock swooning, and comes two weeks after the Food and Drug Administration approved Vioxx to treat children as young as 2 years old. The FDA did not return phone calls yesterday about its decision on children.

Merck, in noting the dangers of its drug, indicated that as of yesterday it was being taken by more than 2 million people around the world. An estimated 84 million Vioxx prescriptions were written since 1999, when it was approved.

Patients are being told to stop taking the painkiller and that ordinary over-the-counter drugs, which are far less expensive, should work just as well.

In the Puget Sound area, some health providers said they have tried for years to steer doctors away from Vioxx.

Droves of panicky patients called doctors and pharmacists yesterday, most worrying about heart attacks and strokes, but also worrying that a drug they liked was suddenly gone.

Merck spokesman Kevin Colgan said the decision to voluntarily recall the drug came after a series of meetings with top company officials and scientists. The meetings followed word that patients on Vioxx in a Merck-sponsored clinical trial experienced double the risk of cardiovascular problems compared with those on a placebo.

Getting a refund Merck, the maker of Vioxx, promised to refund patients for unused pills. It is asking consumers to mail the medication in the original container to NNC Group, Merck Returns, 2670 Executive Drive, Indianapolis, IN 46241. Newsday

Colgan said the trial known as APPROVe, was designed to test the effectiveness of Vioxx in the prevention of colon polyps, precursors to cancerous tumors in the colon.

The study, he said, began in 2000 and was scheduled to run through November of this year. Vioxx had lagged behind its competitor, Celebrex, a Pfizer product, in tests as a cancer medication. The APPROVe trial was an attempt, some observers say, to put Vioxx on more even footing with Celebrex as a potential cancer medication. Now, they say, the whole class of drugs is being called into question.

"We warned our readers in 'Worst Pills, Best Pills' back in 2001 not to use Vioxx," said Dr. Sidney Wolfe of Public Citizen, the medical watchdog group that publishes the book.

Wolfe said heart damage caused by Vioxx has been known for years and that the FDA continually has ignored warnings about it. He said Celebrex and the only other approved medication in the class, Bextra, also should be taken with caution. In addition to arthritis, the drugs are prescribed for acute-pain syndromes, including migraine headaches and carpal tunnel syndrome.

Vioxx, Celebrex and Bextra belong to the class of medications known as COX-2 inhibitors, which block an enzyme called cyclooxygenase-2, which is involved in sensations of pain and inflammation. When COX-2 enzymes flare, pain is perceived. They were a dramatic improvement on aspirin and other nonsteroidal anti-inflammatory drugs — NSAIDs — which are COX-1 and 2 inhibitors. When the enzyme COX-1 is blocked, stomach irritation ensues and ulcers can occur. But researchers now believe Vioxx causes abnormal blood clotting, increasing the risk of heart attacks and strokes.

In Washington state, more than 30 patients called Dr. Shawn Slack, a rheumatologist at The Everett Clinic, who prescribed the drug for patients who couldn't tolerate other NSAIDs. "They were more worried about having a heart attack or stroke," he said. But the next question was: "OK, now what do I do?"

At The Everett Clinic, pharmacy services director Jennifer Wilson Norton said none of the COX-2 inhibitors are on the clinic's formulary, or list of approved drugs, although doctors are free to prescribe them. "We have been concerned about the safety risk of these drugs," she said. For most patients, she said, other drugs work fine, cost less and don't have the safety concerns. "Just because there's a commercial on TV that says it's good for you doesn't mean there's not a risk."

At Group Health Cooperative, Dr. Marc Mora, head of the committee that evaluates medicines being considered for its formulary, said information provided by the FDA — but never published — clearly indicated "significant concerns" about Vioxx. As a result, Group Health never listed the drug among those provided free to members.

"We took a lot of heat, both from patients and from physicians outside of Group Health that we didn't make this therapy available on our formulary," Mora said. Group Health's stance of being conservative about adopting new therapies, he said, not only saved money, but was safer as well. "In retrospect, it was exactly the right thing to do."

About 1,100 of Group Health's nearly 540,000 members, despite the concerns, take Vioxx, paying for it out of pocket.

Seattle Times staff reporter Carol M. Ostrom contributed to this report.

Copyright © 2004 The Seattle Times Company

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