WHO Pharmaceuticals Newsletter 2005, No. 05
(2005; 13 pages) View the PDF document
Table of Contents
Close this folderREGULATORY MATTERS
View the documentIbritumomab - Skin reactions warning added to labels
View the documentMorphine sulfate extended release capsules - Alcohol promotes rapid release
View the documentPemoline - Withdrawn due to liver toxicity risk
View the documentTamsulosin hydrochloride - Risk of Intraoperative Floppy Iris Syndrome (IFIS)
Open this folder and view contentsSAFETY OF MEDICINES
Open this folder and view contentsPROBLEMS OF CURRENT INTEREST
Open this folder and view contentsFEATURE
 

Pemoline - Withdrawn due to liver toxicity risk

USA. The US FDA has concluded that the overall risk of liver toxicity from pemoline (Cylert) outweighs the benefits of this drug indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD).

FDA is aware of 13 reports of liver failure resulting in liver transplant or death associated with pemoline use. A boxed warning was added to the label regarding the liver toxicity. This led to fewer prescriptions being written for pemoline (1/5 the earlier number). But, the FDA is of the opinion that the risk remains, particularly when considering the fact that one new case of pemolineassociated liver failure was reported even after the improved labelling intervention.

The manufacturer (Abbott) of the proprietary version (Cylert) of the product discontinued its sales in May 2005. Subsequently, manufacturers of the generic versions have also agreed to stop sales and marketing of pemoline products. Health-care providers who currently prescribe pemoline products are advised to switch their patients to an alternative therapy.

Reference:

Alert. United States Food and Drug Administration, October 2005 (http://www.fda.gov).

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