Thursday, September 30, 2004

TRENTON, N.J. (AP) — Vioxx, the blockbuster arthritis drug taken by 2 million people, was pulled from the market by its maker yesterday after a study found it doubled the risk of heart attacks and strokes.

Experts advised patients to immediately stop taking Vioxx and talk to their doctors about alternatives.

“Given the availability of alternative therapies, and the questions raised by the data, we concluded that a voluntary withdrawal is the responsible course to take,” said Raymond V. Gilmartin, chairman, president and chief executive officer of Merck & Co.

The news of Vioxx’s dangers came five years after Merck put the drug on the market with great fanfare. Vioxx has become one of the world’s most aggressively marketed drugs, advertised in magazines and in TV commercials, with celebrity endorsements from former athletes Dorothy Hamill and Bruce Jenner.

The withdrawal is a serious blow for the New Jersey company, the world’s third-largest drug maker. Vioxx accounted for $2.5 billion in worldwide sales in 2003 and has been taken by 84 million people worldwide since its introduction.

Merck stock fell $12.07, or nearly 27 percent, to $32.90 in heavy trading on the New York Stock Exchange yesterday. Merck dragged down the Dow Jones Industrial Average, which was off by 56 points.

Merck’s recall of its Vioxx painkiller surprised pharmacies in the United States and Canada, leaving them unprepared to handle questions from concerned patients and doctors looking for alternatives and trying to get information about reimbursement.

Vioxx, which is also prescribed for acute pain and disorders such as carpal tunnel syndrome, is seen as a potential cancer-prevention medicine. In fact, the recall was prompted by a three-year study aimed at showing the drug could prevent the recurrence of potentially cancerous polyps in the colon and rectum.

Participants taking Vioxx for more than 18 months were found to be twice as likely as those given placebos to have a heart attack, stroke or other heart complications.

The Food and Drug Administration said there were early signs of potential problems with Vioxx. A Merck study led to warnings about heart risks being placed on the drug’s label in 2001, and the FDA has been monitoring problems that have been reported since then.

“This is not a total surprise,” said Dr. Steven Galson, acting director of the FDA’s Center for Drug Evaluation and Research.

Vioxx is part of a class of anti-inflammatory drugs called cox-2 inhibitors that have been heavily touted by the pharmaceutical industry as being more effective and having fewer side effects, particularly on the stomach, than older drugs. Pfizer’s Celebrex and Bextra are also cox-2 inhibitors. But so far there has been no evidence that these other drugs pose any dangers to the heart.

Officials do not know how Vioxx may be causing the increased risk.

Alternatives to Vioxx include generic pain relievers such as ibuprofen and aspirin, as well as Celebrex.

“There are very few patients for whom there won’t be a good alternative drug,” said Dr. Steven Abramson, director of rheumatology at New York University Hospital for Joint Diseases. Dr. Abramson said there is no reason for those who used Vioxx in the past to panic; he said there is no evidence that the elevated risk of heart attack persists after a patient has stopped taking the drug.

Personal-injury lawyers already have begun circling Merck. Trial lawyer Wayne Cohen said the decision has opened the company up to tremendous legal jeopardy.

Besides possibly knowing about the harmful effects and not acting quickly enough, the company is also vulnerable to huge settlements because the injuries — cardiovascular problems and stroke — are debilitating and costly, said Mr. Cohen, the president for the D.C. branch of the Association of Trial Lawyers of America.

“One hundred million people have used Vioxx and therefore the potential for claimants is monumental,” he said. “You also have users of Vioxx that are not injured now but may need to get monitored.”

A law firm in Oklahoma City, Federman & Sherwood, said it had filed the first lawsuit subsequent to Merck’s recall of the drug. Within hours of the recall announcement, lawyer Barry Slotnick of New York announced plans to file an unspecified number of federal lawsuits on behalf of Vioxx users.

“It’s a disaster for Merck, coming at the worst time,” said health care analyst Hemant Shah of HKS & Co. in Warren, N.J.

Merck said patients with leftover pills can mail them back to the company for a refund. Vioxx is costly, with a 30-day supply costing about $100, far more than generic pain relievers.

Vioxx was the 20th-best-selling drug in the United States last year. But sales dipped 18 percent in the second quarter of this year to $653 million, partly because of increasing concerns about the drug’s safety.

• Staff writer Marguerite Higgins contributed to this report.

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