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Pemoline and Hepatic Failure in Children

Received 17 January 1997: In December 1996, Abbott Laboratories advised health care professionals of a labeling change for Cylert. A recent review of post marketing experience with Cylert disclosed ten reports from the U.S. of acute liver failure in children, with additional reports of liver failure in adults and in children from foreign countries.

Based on discussions with the Food and Drug Administration (FDA), Abbott Laboratories has modified the current product labeling to include a boxed warning describing liver failure and to indicate that Cylert should not ordinarily be considered as first line drug therapy for Attention Deficit Hyperactivity Disorder (ADHS). The following is the text of the boxed warning.

Because of its association with life threatening hepatic failure, CYLERT should not ordinarily be considered a first line drug therapy for ADHD (see INDICATIONS AND USAGE.)

Since CYLERT's marketing in 1975, 13 cases of acute hepatic failure have been reported to the FDA. While the absolute number of reported cases is not large, the rate of reporting ranges from 4 to 17 times the rate expected in the general population. This estimate may be conservative because of under reporting and because the long latency between initiation of CYLERT treatment and the occurrence of hepatic failure may limit recognition of the association. If only a portion of actual cases were recognized and reported, the risk could be substantially higher.

Of the 13 cases reported as of May 1996, 11 resulted in death or liver transplantation, usually within four weeks of the onset of signs and symptoms of liver failure. The earliest onset of hepatic abnormalities occurred six months after initiation of CYLERT. Although some reports described dark urine and nonspecific prodromal symptoms (e.g., anorexia, malaise, and gastrointestinal symptoms), in other reports it was not clear if any prodromal symptoms preceded the onset of jaundice. It is also not clear if the recommended baseline and periodic liver function testing are predictive of these instances of acute liver failure. CYLERT should be discontinued if clinically significant hepatic dysfunction is observed during its use (see PRECAUTIONS).

MedWatch is the FDA Medical Products Reporting Program for health-care professionals.

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