FDA Alerts related to Cylert (Pemoline)
FDA ALERT [10/2005]: Liver Injury Risk and Market Withdrawal
The Agency has concluded that the overall risk of liver toxicity from Cylert and generic pemoline products outweighs the benefits of this drug. In May 2005, Abbott chose to stop sales and marketing of Cylert in the U.S. All generic companies have also agreed to stop sales and marketing of this product (Pemoline tablets and chewable tablets). Cylert is a central nervous system stimulant indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD). This product is considered second line therapy for ADHD because of its association with life threatening hepatic failure (see
BOXED WARNING in product label and patient package insert, available
at
http://www.fda.gov/cder/foi/label/2003/016832s022_017703s018lbl.pdf
FDA intends to update this sheet when additional information or analyses become available. For complete, up-to-date safety information by the FDA, see MedWatch
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