In response to pharmaceutical giant Merck & Co.'s announcement that it is pulling its blockbuster arthritis drug Vioxx worldwide because of increased heart attack and stroke risk, the Food and Drug Administration advised patients taking the drug to consult their doctors about switching to another medication.
Merck cited new data from a three-year study that showed the increased risk of heart attack and other cardiovascular complications began 18 months after patients started taking Vioxx.
The FDA had previously warned about heart dangers for people taking the popular drug. In August the agency released a study showing that patients taking the highest recommended daily dosage of Vioxx had three times the risk of heart attack and sudden cardiac death as those not taking standard painkillers.
Sudden cardiac death, an abrupt loss of heart function that is not considered a heart attack, is a leading cause of death in the United States.
Acting FDA Commissioner Dr. Lester M. Crawford said that Merck was right in pulling the drug voluntarily.
"Although the risk that an individual patient would have a heart attack or stroke related to Vioxx is very small, the study that was halted suggests that, overall, patients taking the drug chronically face twice the risk of a heart attack compared to patients receiving a placebo," Crawford said in a statement Thursday.
The FDA also said Thursday that it will closely monitor other drugs in this class for similar side effects.
"All of the NSAID drugs have risks when taken chronically, especially of gastrointestinal bleeding, but also liver and kidney toxicity. They should only be used continuously under the supervision of a physician," said Crawford.
What should you do?
—The FDA says patients should contact their doctors about alternative treatment.
—Doctors are being advised to take their patients off Vioxx.
—Merck says it will reimburse patients for any tablets they currently have.
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—For now, patients should keep the tablets and wait for more information.
—Merck will post reimbursement information on http://www.vioxx.com or people can call 1-888-368-4699.
Vioxx is one of Merck’s most important drugs, with $2.5 billion in sales in 2003. It's the 16th most used drug in the U.S. and more than 84 million people around the world have taken it, analysts say.
But sales dipped 18 percent in the second quarter of this year to $653 million, partly due to increasing concerns about the drug’s safety.
“We’re taking this action because we believe it best serves the interest of patients,” Ray V. Gilmartin, Merck’s chairman, president and chief executive, said in a prepared statement.
“Although we believe it would have been possible to continue to market Vioxx with labeling that would incorporate these new data, 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,” he said.
Merck, the world’s third-biggest drug maker, announced the news before the stock market opened. In early trading on the New York Stock Exchange, Merck shares plunged $11.40, or more than 25 percent, to $33.67.
The FDA approved Vioxx in 1999 for treating pain and inflammation caused by osteoarthritis, as well as for acute pain in adults and for women with menstrual cramps. The FDA later approved Vioxx to treat the signs and symptoms of rheumatoid arthritis in adults and children.
The hope was that Vioxx would have fewer side effects and cause less stomach bleeding and ulcers than pain medications such as ibuprofen.
The FDA was in the process of determining whether to add the new warning to the drug labeling when Merck informed the agency of the results of the new trial and its decision to withdraw Vioxx from the market.
The Associated Press and Reuters contributed to this report