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Pfizer’s Bextra Pulled by FDA for Harmful Side Effects

The Food and Drug Administration forced Pfizer Inc. to pull its drug Bextra off the market on April 7, 2005. The drug, a cox-2 inhibitor, has already been linked to an increase risk for cardiovascular problems and may now be linked to an increased risk for Stevens-Johnson Syndrome, a rare and potentially fatal skin disease.

The Agency also issued its strongest “blackbox” warnings for other non-steroidal, anti-inflammatory drugs (NSAID). These medications include Celebrex and over-the-counter products such as Advil, Aleve and Motrin. The warning will indicate that these drugs carry an increased risk of gastric bleeding and heart attacks.

Bexta is a nonsteroidal anti-inflammatory drug (NSAID), which was approved for use by the FDA in November 2001. It was prescribed for relief of the signs and symptoms of osteoarthritis, adult rheumatoaid arthritis and primary dysmenorrhea (pain associated with menstruation). The recommended dose for the signs and symptoms of arthritis was 10 mg once daily; the recommended dosage for primary dysmenorrhea was 20 mg twice daily, as needed.

A recent meeting by the American Heart Association discussed the possible side effects of Bextra on the heart. It was claimed that Bextra patients undergoing heart surgery could be at increased risk.

The cox-2 inhibitors have been embroiled in controversy since Merck & Co. voluntarily withdrew its blockbuster drug Vioxx from the market last September, after a study showed it doubled patients' risk of heart attack and strokes.

Another study by WellPoint Inc., inked the painkillers (Vioxx, Celebrex and Bextra) to increased cardiovascular risk, further reinforcing findings of other trials that already have sparked concern over the safety of the popular category of drugs.

That study indicated that Vioxx increased patients' risk of heart attack and stroke by about 20 percent while Bextra increased the risk by 50 percent.

The FDA advised patients to seek their doctors' advice and emphasized that short-term use of over-the-counter strength versions of the NSAID medicines does not appear to pose the same risks.

Additional information about the FDA’s announcements is available on its Web site at www.fda.gov/cder. Information can also be obtained by calling 1-888-INFO-FDA (888-463-6332).

ABOUT THE AUTHORS: Arthur Penn, Esq., and Joseph Gorman, Esq., practice class action and mass tort litigation as attorneys with the Princeton, Mt. Holly and Nutley, New Jersey law firm of Pellettieri, Rabstein and Altman. Mr. Penn is a former Director of the Division of Public Interest Advocacy for the New Jersey Department of the Public Advocate (1974-1978), Assistant Commissioner, New Jersey Department of the Public Advocate (1979-1981), and Member, New Jersey Supreme Court Committee on Civil Procedure (1978-1981).

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