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Drug Profile

Do NOT stop taking this or any drug without the advice of your physician. Some drugs can cause severe adverse effects when they are stopped suddenly.

Do Not Use [what does this mean?]
Generic drug name: pemoline (pem OH leen)
Brand name(s): CYLERT
GENERIC: not available FAMILY: Central Nervous System Stimulators
Find the drug label by searching at DailyMed.

Alternative Treatment [top]

Safety Warnings For This Drug [top]

FDA BLACK BOX WARNING

Because of its association with life threatening hepatic failure, CYLERT should not ordinarily be considered as first-line drug therapy for ADHD. Because CYLERT provides an observable symptomatic benefit, patients who fail to show substantial clinical benefit within three weeks of completing dose titration, should be withdrawn from CYLERT.

Since CYLERT’s marketing in 1975, 15 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 15 cases reported as of December 1998, 12 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.

Treatment with CYLERT should be initiated only in individuals without liver disease and with normal baseline liver function tests. It is not clear if baseline and periodic liver function testing are predictive of these instances of acute liver failure; however it is generally believed that early detection of drug-induced hepatic injury along with immediate withdrawal of the suspect drug enhances the likelihood for recovery. Accordingly, the following liver monitoring program is recommended: Serum ALT (SGPT) levels should be determined at baseline, and every two weeks thereafter. If CYLERT therapy is discontinued and then restarted, liver function test monitoring should be done at baseline and reinitiated at the frequency above.

CYLERT should be discontinued if serum ALT (SGPT) is increased to a clinically significant level, or any increase = 2 times the upper limit of normal, or if clinical signs and symptoms suggest liver failure.

The physician who elects to use CYLERT should obtain written informed consent from the patient prior to initiation of CYLERT therapy.

Drug treatment is not suitable for all children with attention deficit hyperactivity disorder (ADHD). Drug treatment is not intended for use in patients who exhibit symptoms of the disorder that result primarily from environmental factors (school, home), learning disabilities, and/or other psychiatric disorders, including psychosis.

Pemoline (CYLERT) was withdrawn from the market in the UK in the fall of 1997 and in Canada in 1999 because of serious liver toxicity.[1]

Facts About This Drug [top]

Pemoline was originally approved for use in the U.S. in January 1975. The drug was withdrawn from the market in the U.K. in the fall of 1997 because of cases of serious liver toxicity.[2] The decision by British authorities was based on U.S. reports of 33 serious liver reactions that led to liver transplants in two cases and death in another six patients. In addition, the evidence for pemoline’s effectiveness in treating attention deficit/hyperactivity disorder (ADHD) is limited, and there is...

Pemoline was originally approved for use in the U.S. in January 1975. The drug was withdrawn from the market in the U.K. in the fall of 1997 because of cases of serious liver toxicity.[2] The decision by British authorities was based on U.S. reports of 33 serious liver reactions that led to liver transplants in two cases and death in another six patients. In addition, the evidence for pemoline’s effectiveness in treating attention deficit/hyperactivity disorder (ADHD) is limited, and there is no strong evidence from appropriate clinical trials that it is effective for patients who have failed to respond to alternative drugs.  It was removed from the market in Canada for similar reasons in 1999.

In 1996, there had been 193 cases of liver toxicity, including nine deaths in children under age 20.[3]

This drug is no longer marketed in the U.S., either because it was withdrawn for safety reasons or because its manufacturer discontinued its production.

Regulatory actions surrounding pemoline

1999: In June, the Food and Drug Administration (FDA) made extensive safety labeling changes to pemoline’s professional product label. The changes included a black box warning about the drug’s potential to cause liver toxicity and the necessity for the prescribing physician to obtain the patient’s written informed consent before prescribing pemoline. A black box warning is the strongest type of warning that the FDA can require in a drug’s professional product labeling or package insert.

2005: In April, Public Citizen petitioned the FDA to remove CYLERT and its generic form, pemoline, from the market because it is both less effective and less safe than other currently available ADHD drugs.[4] The following October, the FDA concluded that the overall risk of liver toxicity from CYLERT and generic pemoline products outweighs the benefits of this drug.[5] Shortly after Public Citizen issued its petition, the drug’s manufacturer, Abbott Laboratories, chose to stop sales and marketing of pemoline in the U.S. All generic companies have also agreed to stop sales and marketing of this product.

Health care professionals who prescribe CYLERT or any of its generics should transition their patients to an alternative therapy. CYLERT will remain available through pharmacies and wholesalers until supplies are exhausted. No additional product will be available.[5]

last reviewed May 31, 2021