A food and Drug Administration advisory panel has recommended that Merck & Co. could resume selling the painkiller Vioxx, but must include stringent warnings of the heart problems it can cause and restrictions on its use.
On Friday, the panel also decided that, like Vioxx, drugs Celebrex and Bextra pose cardiovascular risks but offer enough benefits that they should remain available — with warnings and limits similar to those for Vioxx.
The FDA said that it would act within weeks on the recommendations but cautioned that does not mean Vioxx would quickly return to the market. FDA officials conceded that the issues before the panel were complex and sifting through their comments will take time. The agency generally follows the panel’s suggestions.
The panel’s decisions were the culmination of three days of unusual testimony at which some patients made passionate pleas to keep the drugs available while a few asked for more warnings. Medical experts unveiled data showing increased heart risks for some drugs and lesser risks for others, while drug companies defended their products as safe.
Millions of patients who used the painkillers have been unsure about their safety. Merck pulled Vioxx from the market on September 30 after a trial showed it doubled the risk of heart attack and strokes. — NYT