Abbott, United States of America. The manufacturer of pemoline (Cylert: Abbott) has written to health professionals to advise them of an update to the warnings section in the labelling for pemoline, a central nervous system stimulant indicated for the treatment of attention deficit hyperactivity disorder (ADHD). Although there has been no change in the reported rate of acute hepatic failure associated with the use of pemoline, the labelling has been revised based on discussions with the Food and Drug Administration (FDA) to provide updated recommendations for liver function monitoring and a “Patient Information/Consent” form.
Before prescribing pemoline, the physician should be thoroughly familiar with the details of the pemoline prescribing information. Pemoline should not be prescribed until there has been a complete discussion of the risks with the patient. The “Patient Information/Consent” form should be reviewed with any patient currently taking pemoline or any new patient for whom pemoline is to be prescribed. In addition, written informed consent should be obtained.
The black box warning together with the relevant sections of the product labelling have been revised accordingly.
[See also Pharmaceuticals Newsletter Nos. 11&12, November & December 1997]
Reference: FDA Medical Bulletin, p. 6, March 1997.