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Merck Withdraws Arthritis Drug Vioxx

By Fred Barbash
Washington Post Staff Writer
Thursday, September 30, 2004; 7:20 PM

Vioxx, a heavily advertised and popular arthritis pain medication, was withdrawn from the market this morning by pharmaceutical giant Merck and Co., based on new study suggesting that Vioxx may increase the risk of heart attack and stroke.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.

_____Questions & Answers_____
What should I do if I take Vioxx? Contact your doctor to discuss how best to discontinue the drug and find alternative treatment.
What are the long-term effects of taking Vioxx? A new study shows the drug may cause an increased risk of heart attack and strokes, though the FDA says such risk is small.
Can I get my prescription filled for Vioxx? No, Merck is withdrawing the drug from all pharmacies in the United States.
What should I do with my Vioxx pills? Keep them. Merck is reimbursing patients for unused medication. Visit www.vioxx.com to find out how to file a claim.
How can I report serious side effects to the FDA? Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
How important is Vioxx to its manufacturer? It's been one of Merck's most important drugs, with $2.5 billion in sales in 2003 -- about 11 percent of the company's revenue.
How will the recall affect Merck stockholders? Merck says it expects earnings per share to fall by as much as 60 cents in the fourth quarter.

_____From Merck_____
Release Announcing Vioxx Withdrawal (PDF)
_____The Heart_____
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
_____Stock Quotes_____
Merck & Co. Inc. (MRK)
Schering Plough Corp (SGP)
Wyeth (WYE)
GlaxoSmithKline Plc (GSK)
Pfizer Inc (PFE)

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.

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