FDA Rejects Bextra-Like Drug

posted on:
September 20, 2005

author:
Staff

The Food and Drug Administration has decided not to approve a special formulation of Pfizer’s recalled pain reliever Bextra that was to be used to treat pain following surgery.

In a release early Tuesday, Pfizer (PFE: news, chart, profile) said that the FDA has issued the company a non-approvable letter for parecoxib, an injected formulation of the company’s once-popular drug Bextra.

Parecoxib is already marketed in Europe under the brand name Dynastat. The drug is considered to be an option to opioids, which can cause respiratory failure in high doses.

On Tuesday, Pfizer said it disagreed with the FDA’s decision on parecoxib and plans to meet with the agency to discuss its concerns about the medication.

The FDA asked Pfizer to take Bextra, also known as valdecoxib, off the market last spring because it had been linked to a rare but sometimes fatal skin reaction known as Stevens-Johnson Syndrome. The drug was also found to cause heart and blood clotting problems in patients who had just undergone coronary artery bypass surgery.

After conducting a safety review of the drug, the FDA determined that Bextra’s benefits did not outweigh its risks for it to remain on the market.

Pfizer has since said it plans to discuss with the FDA how Bextra could be put back on the market, albeit with great restrictions.

Bextra and parecoxib are chemically related to Merck’s pain reliever Vioxx, which was taken off the market last year after a study showed it could cause serious cardiovascular problems in certain patients.

The drugs, along with Pfizer’s widely-prescribed Celebrex, all belong to a class of medications called cox-2 inhibitors, which were once considered wonder drugs in their ability to combat pain without causing stomach problems.

After an extensive safety review last spring, the FDA ruled that Bextra should be withdrawn from the market. The FDA, however, also determined that Celebrex and Vioxx could remain on the market, with certain restrictions warning of cardiovascular risks. Of the three medications, Celebrex was determined to be the safest.

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