Vioxx, a heavily advertised and popular arthritis pain medication, was withdrawn from the market this morning by pharmaceutical giant Merck and Co., based on new study suggesting that Vioxx may increase the risk of heart attack and stroke.
Merck, along with the U.S. Food and Drug Administration, urged patients using Vioxx to contact their health care providers to discuss discontinuing use and possible alternative treatments.
Release Announcing Vioxx Withdrawal (PDF)
Vioxx's Removal May Not Affect Care Much (The Washington Post, Oct 1, 2004)
Merck Withdraws Arthritis Medication (The Washington Post, Oct 1, 2004)
A Weekly Shot of News and Notes (The Washington Post, Sep 28, 2004)
Wasabi as Decongestant? Just Say Nose (The Washington Post, Sep 28, 2004)
Blood Sugar: You, Too (The Washington Post, Sep 28, 2004)
More Heart News
The FDA said it would closely examine other drugs in the same class as Vioxx to determine whether they also can cause heart attacks and strokes.
In a statement issued earlier, the FDA said that patients taking Vioxx regularly "face twice the risk of a heart attack compared to patients receiving a placebo."
Vioxx is in a class of painkillers known as COX-2 inhibitors, which also includes Pfizer's Celebrex and Bextra, an experimental drug called Prexige made by Novartis AG and another Merck drug called Arcoxia that the company has been seeking FDA approval to market.
In a press release, Merck said its data did not necessarily implicate any other company's drug.
Steven Galson, acting director of the FDA's Center for Drug Evaluation and Research, told reporters in a conference call that the agency is "going to be more interested in looking at long-term data on new products that come down the pike." He said he was referring to COX-2 inhibitors now on the market as well as those awaiting FDA approval.
The news drove Merck's stock sharply downward, slashing its market value by $25 billion, the Reuters news agency reported. Vioxx brings in more than $2.5 billion annually for Merck and constitutes roughly 10 percent of the pharmaceutical company's worldwide sales.
Some previous studies have found a link between Vioxx and heart risk. In June, 2000, Merck had alerted the FDA to the problem. But the FDA said today that after reviewing the results at that time, it determined that a warning on the package would suffice.
Vioxx has been on the market since 1999 and is sold in 80 countries. In some countries the drug is called Ceoxx rather than Vioxx. In the United States, at least 23.5 million prescriptions for Vioxx were written in 2003, according to IMS Health, a pharmaceutical information and consulting company.