Healthy Skepticism Library item: 991
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Publication type: news
Hensley S.
FDA Says It Is Too Soon to Tell If Vioxx's Risks Apply to Class Merck's Recall Decision Raises Safety Questions In Similar Arthritis Drugs
Wall Street Journal 2004 Oct 19
Full text:
A Food and Drug Administration official said it is premature to say whether the cardiovascular risks that led to the withdrawal of Vioxx by Merck & Co. apply to similar drugs for arthritis.
“Is this a class effect and do we have to worry about the other drugs on the market?” Janet Woodcock, acting deputy commissioner for operations at the FDA, said during a presentation to arthritis specialists here. “At this point, we don’t have any definitive evidence.”
Her comments came after results from the study that led Merck to pull Vioxx from the market last month were reviewed with doctors attending the American College of Rheumatology’s annual scientific meeting. Nearly 3,000 people jammed the special session held in the Henry B. González Convention Center’s largest ballroom.
Vioxx reduces inflammation and pain by blocking an enzyme called Cox-2. The remaining Cox-2 inhibitors on the U.S. market are Celebrex and Bextra, both made by Pfizer Inc. Merck is awaiting word from the FDA on whether its second-generation Cox-2, called Arcoxia, will be approved.
Dr. Woodcock said studies of Celebrex to prevent Alzheimer’s disease and colon cancer should provide more certainty about the safety profile from that drug over time. She also promised “careful scrutiny of new agents” in the class by the FDA. “We are far from understanding the complex mechanisms that may lead to this toxicity,” she said.
The Merck study, called APPROVe for short, aimed to determine whether Vioxx taken for three years could prevent polyps in the colon from becoming cancerous. The Cox-2 enzyme also has been found in high concentrations in some tumors. Researchers hypothesized that treating patients at high risk of developing certain colon cancers with Cox-2 inhibitors might be spared the disease.
Robert Bresalier, a gastroenterologist at the M.D. Anderson Cancer Center in Houston who serves on the APPROVe study’s steering committee, presented the results. In the clinical test, more than 2,500 patients received either 25 milligrams of Vioxx, a widely used dose for arthritis pain, or a sugar pill. Almost a fifth of the patients from both groups took aspirin to ward off cardiovascular illness.
A preliminary analysis showed 45 confirmed cardiovascular events, such as heart attacks, among Vioxx patients compared with 25 cardiovascular events in patients taking the placebo. It was the doubling of the rate of cardiovascular problems for patients taking Vioxx 18 months or longer that led Merck to yank the drug from the market last month.
Today, doctors also will hear results on a clinical test of Arcoxia. The FDA is expected to formally respond to Merck’s application for approval of the drug by the end of the month. Analysts believe approval won’t come until after a longer study of the drug.
An abstract of the results released before the presentation said that Arcoxia was tolerated as well or better than diclofenac, an older anti-inflammatory medicine, in more than 7,000 patients who took one drug or the other for an average of nine months. There were no significant differences between them in serious adverse events.
