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FDA Announces Hearings on Vioxx and Celebrex Family of Drugs

Posted on: Friday, 14 January 2005, 21:00 CST

Jan. 15--The federal Food and Drug Administration announced Friday that it will hold three days of hearings next month on the benefits and risks of the COX-2 family of drugs, which includes Pfizer Inc.'s popular Celebrex and Bextra arthritis medications.

The FDA said its arthritis advisory committee and its drug safety and risk management group will hold the hearings on Feb. 16, 17 and 18 at the Hilton Washington North hotel in Gaithersburg, Md.

The hearing is expected to attract a host of pharmaceutical and medical representatives to discuss the overall safety of the popular but controversial family of drugs, which are used to quell acute pain and inflammation. Since questions surfaced this past fall over the possible cardiovascular risks of the drugs, intense media coverage ensued and the regulatory agency agreed to hold public hearings.

Kathleen Quinn, a spokeswoman for the FDA, said regulators would allow the public to comment, either orally, in writing or with data. Public comments would be allowed during the first day of the hearing between 1 and 3 p.m., but time would be limited. Those interested in making a presentation, she said, should register to speak at the meeting before Friday, Feb. 4. More information about the meeting and information about registering will be found on the agency's Web site in the coming days at www.fda.gov.

Pfizer spokeswoman Susan Bro said that Pfizer officials have been asked to make presentations during the three-day hearing and will participate. But she said the company is still working out the details and hasn't determined which officials will be making presentations at the Maryland session.

Pfizer's Celebrex and Bextra, which have generated sales of some $3 billion during the first nine months of 2004, are among the leading COX-2 drugs used by millions of patients who suffer from arthritis-related conditions or acute pain or inflammation. Pfizer's shares on the New York Stock Exchange slipped slightly Friday, closing the day's trading at $25.25 a share, down less than a percent from the prior day's trading. New York-based Pfizer employs about 6,000 people at its research campuses in Groton and New London.

Quinn said the FDA hearings would discuss the overall benefit-to-risk considerations of COX-2 drugs, including cardiovascular and gastrointestinal concerns.

COX-2 drugs began to come under closer media and industry scrutiny last fall when the New Jersey-based Merck & Co. announced that it would pull its blockbuster Vioxx drug from the shelves in late September. Since then, studies have shown other cardiovascular-related events such as heart attacks or strokes stemming from use of the acute pain drugs. Pfizer has maintained that its COX-2 drugs have a different molecular composition than Vioxx.

COX-2 drugs are often preferred by doctors and patients over conventional painkillers because they don't cause the same stomach upset or gastrointestinal bleeding as such over-the-counter remedies as Tylenol or naproxen, an ingredient in Aleve and other private-label brands.

In December, a federal cancer trial using high dosages of Celebrex was halted after researchers found an increased risk of heart attack or stroke, but another federal study on Alzheimer's disease also using Celebrex found no such risk.

Pfizer has said that it has studied Celebrex's cardiovascular safety in 15 clinical trials involving nearly 30,000 patients and found no significant increase in risk of heart attack or stroke compared with traditional pain medications used to treat arthritis-related conditions. The drugs are also known as non-steroidal anti-inflammatory drugs, or NSAIDs. The entire class of these drugs, however, has never been studied for cardiovascular safety in large, multi-year studies.

Pfizer has said that all drugs have risks and benefits, and the company welcomed the February hearing on the COX-2 inhibitor drugs. It also has encouraged patients to consult with their physicians regarding the use of any drug for arthritis or pain treatment.

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PFE, HLT,

Source: The Day

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