Summary
A FDA advisory panel voted 17-15 that the arthritis painkiller Vioxx is safe enough to be prescribed to patients, as long as they are warned of the risks. Pharmaceutical giant Merck pulled the popular drug off the market last September, when an internal study showed that patients taking the drug for 18 or more months had double the risk of stroke or heart attack that those taking a placebo.
Original source:
http://abcnews.go.com/US/wireStory?id=513750
Details
Merck & Co. Inc.'s withdrawn arthritis drug Vioxx is safe enough to rejoin Pfizer's rival pain relievers Celebrex and Bextra on the U.S. market, an advisory panel said after concluding that all three medicines posed some level of heart risk.
The 17-15 vote on Vioxx's safety to go to market electrified Merck shares, which closed up 13 percent at $32.61 on the New York Stock Exchange.
Pfizer Inc. gained 6.9 percent to close at $26.80.
It was a stunning turnaround for Vioxx, which was withdrawn in September by Merck after a study showed the drug doubled heart attack and stroke risk compared with a placebo in patients who took it for at least 18 months.
Celebrex and Bextra, which had been under the same cloud of elevated risks of heart problems, also could stay on the market, the panel said.
Most members felt all three drugs should have "black box" warnings --- the strongest warnings used for prescription drugs --- explaining their heart risks.
Many urged restrictions if Vioxx is sold again, such as limiting sales to the lowest dose and recommending it be a second choice after patients try another pain reliever.
John Cush, a rheumatologist at Presbyterian Hospital in Dallas, said the risk of heart problems with Vioxx was "still very small" and he wanted "as many options for my patients as possible."
The FDA usually follows advice from its panels.
Officials said the agency will make final decisions on Celebrex and other pain relievers in the next few weeks.
"Merck has appreciated the opportunity to present data at this advisory committee meeting," the company said in a statement.
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Monday, February 28, 2005
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