- The Washington Times - Friday, February 18, 2005

Vioxx, the painkiller that was pulled from store shelves on Sept. 30 in the biggest drug recall in U.S. history, can be sold with strict warnings, an advisory committee for the Food and Drug Administration ruled yesterday.

In a 17-15 vote, the advisory panel said the benefits of Vioxx outweigh the increased risk of heart attacks and strokes in some patients.

The panel, made up of 32 doctors and scientists, also ruled that Celebrex and Bextra were acceptable for the market, but said all three drugs, which are part of a drug class known as Cox-2 inhibitors, raise the risk for heart problems.

Cox-2 painkillers work by targeting and suppressing the body’s production of a Cox-2 enzyme, which is linked with pain and swelling.

The panel also said older pain medications such as ibuprofen and naproxen should have warning labels, even if they only state a lack of clear information about potential heart risks.



None of the panel’s decisions are final, but the FDA generally follows the recommendations of its advisory panels.

An FDA spokeswoman said there is no current timetable on when the agency would make a decision.

The agency, which regulates U.S. prescription drug sales, hosted the three-day hearing with numerous pharmaceutical representatives, scientists and doctors this week in Gaithersburg to determine whether the Cox-2 drug class is safe.

Merck & Co. Inc., the Whitehouse Station, N.J., drug company that makes Vioxx, had said earlier in the three-day hearing that the company would not rule out resuming sales of Vioxx, depending on the panel’s decisions on the drug class.

Merck pulled Vioxx, which had $2.5 billion in 2003 sales, after a study linked the drug to higher risks for heart problems.

“If the advisory committee and FDA concluded that the benefits of this [drug] class outweigh the risks in some patient populations, then we would have to consider the implications of these new data given the unique benefits Vioxx offers,” the company said Thursday, emphasizing it had not changed its position on Vioxx’s withdrawal.

Shares of Merck shot up 13 percent to close at $32.61 on the New York Stock Exchange yesterday, up $3.76 from $28.85 Thursday.

Company spokesman Tony Plohoros would not comment further yesterday.

Additionally, the panel voted 31-1 that Celebrex, New York pharmaceutical company Pfizer Inc.’s arthritis drug, could continue to be marketed.

But the majority of panel members said strict federal regulatory labels should be put on the drug’s packaging. The panel concluded that Celebrex does increase the rate for heart attacks and strokes.

Celebrex, the leading arthritis prescription, posted $3.3 billion in sales last year. But a recent market report showed Celebrex’s share of new prescriptions fell to 7 percent for the week ended Jan. 7, down 15 percent from three weeks earlier, just before a study came out linking the drug to elevated levels of heart attacks and strokes.

The panel also approved Bextra, Pfizer’s newer pain reliever that posted $1.3 billion in sales last year, with a vote of 17-13, with two abstaining.

A Pfizer spokeswoman did not return calls for comment. Pfizer’s stock jumped 7 percent on the New York Stock Exchange yesterday to $26.80, up $1.74 from $25.06 Thursday.

John Boris, a senior health care analyst for New York investment bank Harris Nesbitt Corp., said he was encouraged that the advisory committee had highlighted the benefits of the drug class.

“Based on the votes we saw, the panel has recognized this drug class has a lot of benefits. I think consumers are going to get a clear message” regarding the safety and use of Cox-2 painkillers, said Mr. Boris, who owns an undisclosed number of Pfizer shares.

This article is based in part on wire service reports.

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