The FDA has withdrawn approval for a drug used to treat attention deficit hyperactivity disorder (ADHD) because it has been associated with liver problems, including death, report says.
The move means drug manufacturers will no longer produce generic versions of pemoline, which was developed by Abbott Laboratories and sold under the name Cylert. Abbott discontinued the drug earlier this year, but generic versions have remained available.
FDA is not recalling the drug, instead allowing pharmacies to sell their remaining stock as doctors still using it switch patients to alternative treatments, the report adds.
According to the report, the FDA said it has 13 reports of liver failure resulting in transplant or death among people who took the drug, which has been available for 30 years. There are additional reports of less serious problems.
Although that is a small number, it is well above what the normal rate of such problems among the general population, the FDA said.
The drug acts as a stimulant to the central nervous system.