A 30-year-old Abbott Laboratories Inc. drug for attention deficit disorder poses an unacceptable risk of deadly liver damage and should be banned immediately, a U.S. consumer group said Thursday.
Abbott sells the drug under the brand name Cylert, and generic companies sell a copycat version known as pemoline.
Public Citizen said the drug had caused 21 cases of liver failure, including 13 that were fatal or required transplants.
Britain and Canada have pulled the drug off the market, while the Food and Drug Administration has opted to strengthen warnings twice and allow sales to continue, Public Citizen said.
The warnings have failed to increase doctors’ monitoring of liver function in patients treated with pemoline, which offers no benefit over other therapies, the group argued in a petition to the FDA.
“In light of this evidence of unique liver toxicity without evidence of unique therapeutic benefit, we contend that the only responsible course of action is to remove this dangerous drug from the market,” Public Citizen said.
Cylert is a stimulant that was approved to treat attention deficit hyperactivity disorder, or ADHD, in 1975. Last year, about 117,000 prescriptions for the drug were filled in the United States, according to Public Citizen.
The FDA considered asking Abbott to withdraw Cylert in 1996 but decided the drug could stay on the market if the company started a patient registry to evaluate serious side effects. Public Citizen said there is no evidence the company ever established the registry.
Officials at Abbott could not be reached immediately for comment.
A 2002 study by the FDA found warnings on the Cylert label ”had no measurable effect” on the rates of liver testing for patients, Public Citizen said.
Dr. Fredric Solomon, a psychiatrist and ADHD specialist at the George Washington University School of Medicine, also signed the petition.
Public Citizen has filed several petitions with the FDA over the last year seeking to have various drugs withdrawn.
Earlier this month, the FDA denied a petition from Public Citizen asking for a ban on AstraZeneca Plc’s cholesterol treatment Crestor.
