Public Citizen, a U.S. consumer organization, petitioned the U.S. Food and Drug Administration (FDA) to immediately remove Pemoline ( Cylert ), an Abbott’s CNS stimulant used in the treatment of attention deficit hyperactivity disorder ( ADHD ), from the market because it is known to have caused at least 21 cases of liver failure, including 13 resulting in liver transplantation or death.

In 1999, FDA added a black box warning to the labelling of Cylert.

“ Because of its association with life threatening hepatic failure, Cylert should not ordinarily be considered as first line drug therapy for ADHD .
Treatment with Cylert should be initiated only in individuals without liver disease and with normal baseline liver function tests.”

Pemoline has been withdrawn in Canada and UK due to liver toxicity.

Reports of liver abnormalities appeared in U.S. clinical trials even before the drug was approved by the FDA in 1975.

Between the 1975 approval and 1996, there were 193 adverse drug reactions involving the liver ascribed to Pemoline reported to the FDA that involved patients under the age of 20.
As of May 1996, there were 13 cases of acute liver failure due to Pemoline, 11 of which resulted in death or liver transplantation.

An FDA analysis by Dr. David Graham estimated a 16.8-fold increased risk of acute liver failure due to Pemoline compared to the general population, assuming no underreporting.
Given that adverse events are reported to the FDA about 10 percent of the time, the relative risk for acute liver failure could be closer to 168-fold, according to Public Citizen.

“ The Food and Drug Administration should immediately ban the sale of Pemoline,” said Dr. Sidney Wolfe, director of Public Citizen’s Health Research Group.
“ Relatively safe and effective drug treatments exist for ADHD, and since there are no data that demonstrate Pemoline has any unique benefit over other drugs, there is no responsible basis for keeping this unacceptably dangerous drug on the market. ”

Fredric Solomon, a psychiatrist and ADHD specialist at the George Washington University School of Medicine, has signed the petition.

Pemoline is also sold by generic-drug manufacturers.

Source: Public Citizen, 2005


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