• Defective Drug Side Effects

Find a Lawyer in Your State

Need Help?

The advisers to the FDA strongly favor keeping Celebrex on the market, but the panel is split over Bextra’s benefit. Vioxx, which was removed from the market last September, is still not on sale by a vote of just 17-15.

Although the FDA does not have to follow the recommendations of the panel, the agency usually does. FDA officials promised a prompt response to the panel’s suggestions at the opening of the three-day meeting.

Though the panelists were unanimous in saying COX-2 drugs present risks of heart troubles, the committee noted Bextra studies, while limited, showed a greater risk than Celebrex of adverse effects.

Among the suggestions, advisers recommended restrictions on COX-2 drugs by placing severe “black box” warnings on them, the harshest FDA issued warning short of a withdrawal. More patient information, restricting which patients could get the drugs and possibly banning direct-to-consumer advertising for the products was also suggested.

Both Merck and Pfizer, the maker of Celebrex and Bextra, were criticized for the high budget, aggressive marketing campaigns that led to the high number of American Vioxx and Celebrex users that may have better benefited from older treatments.