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Vioxx Withdrawal Important, But Not Surprising

POSTED: 4:26 pm EDT September 30, 2004
UPDATED: 9:23 pm EDT September 30, 2004

It's not often that the head of a drug company says something that leads newscasts all over the country, but a recent announcement affected millions of consumers and doctors.

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"This morning, Merck is announcing a voluntary, worldwide withdrawal of Vioxx -- our cox-2 inhibitor for arthritis and pain," said Raymond Gilmartin, the chairman of Merck Pharmaceuticals. "We are taking this action because it best serves the interest of patients."

Merck took the action because an ongoing study found that people taking Vioxx for longer than 18 months doubled their risk of having a heart attack or stroke.

With more than 91 million Vioxx prescriptions written since the drug's approval in 1991, consumers all over the country flooded pharmacies and doctor's offices with questions.

"I did not know that it caused heart problems," said Shirley Prather, a Vioxx user.

The news also rocked the stock market. With annual sales of $2.5 billion, Vioxx was a significant part of Merck's bottom line. Merck stock plunged more than 25 percent in very heavy trading.

But cardiologists weren't that surprised. Many have been advising their heart patients for some time to switch to different painkillers.

"Vioxx tends to be more associated with raising blood pressure, causing fluid retention, which might be particularly undesirable in people who have weak heart muscles or heart failure," said Dr. Deepak Bhatt, of The Cleveland Clinic.

Vioxx is one of a class of drugs called cox-2 inhibitors that include Celebrex and Bextra. They are painkillers and anti-inflammatories similar in action to drugs such as Advil, Motrin and Aleve. However, the cox-2 drugs are supposed to be gentler on the stomach, reducing the risk of stomach upset or bleeding -- especially in arthritis patients who must take the drugs for long periods.

Dr. Steven Abramson, of NYU Hospital for Joint Diseases, chaired the panel that recommended the approval for Vioxx five years ago.

"When side effects occur very rarely, you won't see them in the typical study that's presented to the FDA, and you need to follow the use of the drug in the population for a long time after it's approved," Abramson said.

Patients who are currently taking Vioxx should contact their health care providers to discuss discontinuing use of Vioxx and possible alternative treatments. For more information, visit merck.com, vioxx.com, or the Food and Drug Administration's Vioxx page. Patients and health care professionals with questions can also call (888) 36-VIOXX (1-888-368-4699).

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