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Pfizer Says FDA Panel to Examine Bextra Drug Safety

Posted on: Wednesday, 10 November 2004, 21:00 CST

Nov. 11--Pfizer Inc. said Wednesday that the federal Food and Drug Administration plans to convene an advisory committee early next year to look into the cardiovascular safety of the nation's Cox-2 inhibitor drugs that are used for acute pain and inflammation related to arthritis conditions.

Pfizer manufactures two of the nation's best-selling Cox 2 drugs, Celebrex and Bextra. Pfizer made the disclosure Wednesday as part of its response to a New York Times article that questioned the cardiovascular safety of such drugs.

The New York-based Pfizer said the advisory committee would convene in February of next year. "We look forward to a scientific and reasoned evaluation in this appropriate setting," said Joseph Feczko, Pfizer's president of worldwide development.

An FDA spokesperson was unavailable Wednesday to provide further details about the meeting or a date when the group would convene.

Pfizer shares on Wednesday closed down nearly 2 percent, at $27.47 a share, and during the day's trading hit a new 52-week low of $27.13 before recovering slightly by the day's closing trading on the New York Stock Exchange. Pfizer has extensive worldwide research operations, including its research and development headquarters in New London and research and manufacturing facilities in Groton. Locally, it employs about 6,000 in southeastern Connecticut and a total of about 8,000 Connecticut residents, including those who live in the state and commute to its New York headquarters.

The Times article in Wednesday's editions said that the number of heart attacks and strokes was more than double those of patients given placebos, based on preliminary results from a study presented at an American Heart Association meeting in New Orleans.

Both Bextra and Celebrex are in the same drug class as Vioxx, manufactured by Merck & Co., which was pulled from the market in September because of its link to both heart attacks and strokes. So far this year, Celebrex has registered worldwide sales of some $2.3 billion, while Bextra has sold more than $800 million.

Pfizer took issue with the Times article, saying it drew "unsubstantiated conclusions" about the drug's possible effect regarding cardiovascular safety. It also faulted the information, saying it wasn't published in a medical journal or subject to any sort of independent scientific review.

Pfizer has said that Bextra is not associated with any increase in cardiovascular incidents in arthritis patients. "Pfizer has shared Bextra clinical results in a timely manner with regulatory authorities both in the United States and worldwide," Feczko said. Pfizer has said that Bextra may be linked to an increased risk of heart attack or stroke when given to high-risk patients undergoing coronary bypass surgery.

Cox 2 inhibitor drugs are a widely prescribed medication for inflammation and other pain connected with cases of osteoarthritis and rheumatoid arthritis. While conventional over-the-counter medications such as aspirin, ibuprofen and acetaminophen can be used to quell such pain, the Cox 2 drugs are often preferred because they don't cause the stomach upset associated with some of the over-the-counter medications.

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(c) 2004, The Day, New London, Conn. Distributed by Knight Ridder/Tribune Business News. For information on republishing this content, contact us at (800) 661-2511 (U.S.), (213) 237-4914 (worldwide), fax (213) 237-6515, or e-mail reprints@krtinfo.com.

PFE, MRK,

Source: The Day

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