Panel OKs Merck’s Vioxx Return to Market

Merck & Co. Inc.’s withdrawn arthritis drug Vioxx is safe enough to rejoin Pfizer’s rival pain relievers Celebrex and Bextra on the U.S. market, an advisory panel said after concluding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. (PFE.N: Quote, Profile, Research) 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 It was a stunning turnaround for Vioxx, which was withdrawn in September by Merck after a study showed the drug doubled heart attack and stroke risk compared with a placebo in patients who took it for at least 18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.” One opponent to Vioxx sales, panel Chairman Alastair Wood, said “there’s a clear signal this drug appears substantially worse than the others” in its potential to damage the heart. Celebrex seems to be the safest of the three based on what scientists know now, he said. 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. “We look forward to discussions with the FDA.” Most panelists wanted to forbid drug makers from advertising the COX-2 drugs. The FDA cannot order an advertising ban but will consider asking the manufacturers to do so voluntarily, said Dr. John Jenkins, head of the FDA’s Office of New Drugs. Celebrex, Bextra and Vioxx are part of a family called COX-2 inhibitors. The drugs were designed to ease pain as effectively as older, nonprescription drugs known as nonsteroidal anti-inflammatory drugs, or NSAIDs, while being easier on the stomach. NSAIDs include more than 20 drugs such as ibuprofen and naproxen.

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. (PFE.N: Quote, Profile, Research) 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.”One opponent to Vioxx sales, panel Chairman Alastair Wood, said “there’s a clear signal this drug appears substantially worse than the others” in its potential to damage the heart. Celebrex seems to be the safest of the three based on what scientists know now, he said.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. “We look forward to discussions with the FDA.”Most panelists wanted to forbid drug makers from advertising the COX-2 drugs. The FDA cannot order an advertising ban but will consider asking the manufacturers to do so voluntarily, said Dr. John Jenkins, head of the FDA’s Office of New Drugs.Celebrex, Bextra and Vioxx are part of a family called COX-2 inhibitors. The drugs were designed to ease pain as effectively as older, nonprescription drugs known as nonsteroidal anti-inflammatory drugs, or NSAIDs, while being easier on the stomach. NSAIDs include more than 20 drugs such as ibuprofen and naproxen.Only Vioxx has been shown to cause fewer serious stomach problems than the older NSAIDs.Many of the older drugs also seem linked to varying levels of heart damage, although data are limited, panel members said. They recommended a warning on the older medicines saying the effects on the heart had not been fully evaluated.All but one panel member voted in favor of continued Celebrex sales. The vote to keep Bextra on the market was 17-13 with two abstentions.Gail Cawkwell, Pfizer’s medical director for pain and inflammation, said the company was pleased the panel “reaffirmed the importance of these medicines.”John Boris, an analyst with Harris Nesbitt, said Merck’s stock rally “signals that Wall Street expects Vioxx to return to drugstores and that it has potential to achieve annual sales in the $1 billion range.”That’s far below the $2.5 billion in annual sales Vioxx had before it was withdrawn. Even so, Boris said the lower level of sales would be a boon to Merck, whose earnings were expected to fall this year because of the loss of Vioxx.Merck is trying to win permission to sell another COX-2 inhibitor, Arcoxia, in the United States. Novartis also wants FDA approval to market a COX-2 drug called Prexige.Some advisory panel members said the FDA should require more research on heart risks — possibly studies lasting two to three years — with the COX-2 drugs in the pipeline.(Source; Reuters Health, February 2005)