`Son of Vioxx’ Hearings to Begin
NEW YORK _ To some, a new pain reliever dubbed “son of Vioxx” could be a godsend. But to critics, its promise reads too much like the fallen blockbuster medication it’s intended to replace.
Food and Drug Administration officials Thursday will consider whether to approve the Merck substitute, Arcoxia, which already is sold in 63 countries. Opponents want it kept out of U.S. medicine chests because it causes more congestive heart failure and high blood pressure than an older drug, diclofenac. Government documents released Tuesday said drugs like it shouldn’t be approved if safer options are available.
“We learned a huge lesson with Vioxx,” said Dr. Warren Wexelman, a cardiologist at Maimonides Medical Center in New York. “I wouldn’t prescribe it unless it had a safety track record that was better than Tylenol. I wouldn’t take the chance.”
Arcoxia is from a class of drugs called Cox-2 inhibitors and developed to be gentle on the stomach. Two of them, Vioxx and Bextra, were pulled after they were linked to strokes and heart attacks; just one, Celebrex, is still sold.
No one knows why the drugs raise the risk of heart problems, said Dr. Sudhir Diwan of New York-Presbyterian Hospital.
But Arcoxia’s “overall benefit to risk is favorable” for patients needing relief from pain, said Merck spokesman Chris Loder. It should be up to consumers to decide if those risks are worth it, said Dr. Patience White, chief public health officer for the Arthritis Foundation.
Merck wants to target Arcoxia to the 21 million Americans with osteoarthritis – a smaller market than it captured with Vioxx, which also was approved for other arthritis and pain conditions.
“I have a very strong feeling that they should approve it,” said Dr. Gerard Varlotta, director of sports rehab at the NYU-Rusk Institute of Rehabilitation Medicine.
“I had patients who loved Vioxx and would do anything for Vioxx,” Varlotta said. “People found it to be very effective and have never been able to find an adequate substitute.”
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