Healthy Skepticism Library item: 812

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Publication type: news

U.S. committee OKs all 3 arthritis drugs
CBC News 2005 Feb 19

Full text:

A committee advising the U.S. drug regulator ruled Friday that three arthritis drugs linked to heart problems should stay on the American market, a decision that could affect millions of arthritis sufferers.

Committee says drug should still be sold
After 2½ days of hearings, a Food and Drug Administration advisory committee said Celebrex does pose an increased risk to patients taking it, but nonetheless voted 31-1 to let its makers continue selling it because of the anti-inflammatory’s effectiveness in relieving severe pain.

Panelists later voted 14-12 to let a similar drug called Bextra stay on the market, with several members abstaining.

A third vote approved the other painkiller in the COX-2 selective inhibitor class, Vioxx.

The committee said Celebrex seems to pose a lower risk of heart problems than the other two drugs, though some members of the panel complained about the dearth of scientific data placed before them.

FROM FEB. 17, 2005: Keep arthritis drugs on market, U.S. regulator told

The Food and Drug Administration does not have to accept the advisory committee’s recommendation, though it traditionally does so.

In Canada, Health Minister Ujjal Dosanjh said his officials will evaluate the drugs independently of what the FDA decides to do.

“Our scientific experts have been working on this issue for some time,” Dosanjh said Friday afternoon, promising, “We will have public input before we make the final decision.”

It will be at least six or eight weeks before Health Canada decides what to do about the three anti-inflammatory drugs, he said.

FROM FEB. 15, 2005: Ottawa may strengthen arthritis drug warnings

Earlier this week, Dosanjh announced new drug-safety measures, including warnings on potentially risky arthritis medications like Celebrex.

The makers of Vioxx, one of the world’s most popular arthritis medications, pulled it from worldwide pharmacy shelves in September 2004 when studies linked it to a higher incidence of heart and stroke problems among patients taking it.

Studies published later suggested the same kind of problems might affect patients taking the other COX-2 selective inhibitors as well.

INDEPTH: Vioxx, Celebrex: Concerns over popular arthritis drugs

The American drug manufacturer of Vioxx has said that if the FDA decides the benefits of it and similar pain relievers outweigh the risks, the company might consider putting it back on the market.

“We would have to consider the implications of these new data” for Vioxx, said Peter S. Kim, president of Merck Research Laboratories.

Last year, Canadian doctors wrote more than 13 million prescriptions for the drugs, including Vioxx.

With Vioxx off the market, prescriptions for Celebrex in Canada shot up by 38 per cent last October – amounting to more than 100,000 new prescriptions for the drug.