Pemoline chemical structure
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Cylert

Pemoline (sold as Cylert®) is a medication used to treat attention-deficit hyperactivity disorder (ADHD). Under the Convention on Psychotropic Substances, it is a Schedule IV drug . more...

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Pemoline has some advantages over other stimulants in that it doesn't reduce the appetite or cause dry mouth. However, in some patients Pemoline is suspected of causing liver damage, so regular liver tests are performed are those treated with it. Since receiving FDA aproval in 1975, it has been linked with 21 cases of liver failure, of which 13 resulted in liver replacement or death. In 2005, the FDA withdrew approval for Pemoline due to pressure from certain public advocacy groups. Patient support group the Narcolepsy Network tried to persuade the FDA not to ban it, on the grounds that some patients find all other treatments ineffective or to have dehabilitating side effects. The medication was used by an estimated 10,000 Americans afflicted with narcolepsy.

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Cylert warning issued
From Real Living with Multiple Sclerosis, 4/1/00 by Hinson-Smith, Vicki

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
Provided by ProQuest Information and Learning Company. All rights Reserved

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