Public Citizen urged the FDA yesterday to remove Abbott Laboratories' 30-year-old attention deficit drug Cylert from the market because of its effects on the liver.
Public Citizen charged that Cylert had caused 21 cases of liver failure, including 13 cases that had been fatal or had required transplants. The petition to the FDA argues that at least 193 patients have suffered serious consequences from the drug.
Abbott vice president of corporate communications Melissa Brotz told the Reuters news service that Abbott had already decided to discontinue the drug due to slumping sales of the brand.
"We're in the process of discontinuing it . . . but that's because of declining usage and sales because there are generics available," Brotz said.
Brotz told Reuters it anticipated sales of the drug this year to be less than $1 million.
Copycat versions of the drug are sold by generic-drug makers.
Cylert was approved to treat attention deficit hyperactivity disorder in 1975. Last year, 117,000 prescriptions for the drug were filled in the U.S., according to Public Citizen.
The petition comes a wee after the FDA denied a petition from the consumer group asking for a ban on AstraZeneca's cholesterol-lowering drug Crestor.