Cylert (pemoline), a drug often used in children with attention deficit disorder, has also been used off-label for many years to relieve the fatigue related to multiple sclerosis (MS).
In 1993, because of reports of liver failure associated with the drug, the manufacturer recommended liver function evaluation before Cylert is prescribed. Now a much sharper, more forceful warning has been issued by the U.S. Food and Drug Administration (FDA) recommending liver function evaluation every 2 weeks.
Cylert was first marketed in 1975 and, since that time, 15 cases of acute hepatic (liver) failure have been reported. Twelve cases resulted in death or liver transplants. Since underreporting often occurs, the actual number of people affected is most likely higher, and the long dormant period between commencement of Cylert and incidence of liver failure may confuse the association.
The Medical Advisory Board of the National Multiple Sclerosis Society (NMSS) recognizes the issues raised by the FDA but supports the use of Cylert for many individuals with MS and associated nonexertional fatigue. The board states that persons with the disease should obtain baseline liver function profiles before use of Cylert and, then, periodically during use. Although no liver failure has been reported for anyone with MS, extra care should be taken when Cylert is used in combination with Tegretol (carbamazepine) or either of the MS interferon drugs, Avonex (interferon beta-la) or Betaseron (interferon beta-lb).
Patients should also report symptoms of liver involvement such as loss of appetite, jaundice, or nausea.
by Vicki Hinson-Smith
Copyright Springhouse Corporation Apr 2000
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