Since before receiving FDA approval in 1975, Pemoline® has been linked to 21 cases of liver failure, 13 of which have resulted in liver replacement or death.
Recently the Public Citizen has issued a petition to the FDA asking for the drug to be removed from the market. "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."
Pemoline®, which also goes by the generic name Cylert, is a
central nervous system stimulant used in the treatment of attention
deficit hyperactivity disorder (ADHD).
