Cylert Attorneys
FDA MedWatch - Cylert and Generic Pemoline Products Withdrawn
From Market Due to Liver Toxicity
ROCKVILLE, Md., Oct. 24, 2005 - FDA 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.
Cylert, a central nervous system stimulant indicated for the treatment
of Attention Deficit Hyperactivity Disorder (ADHD), is considered second
line therapy for ADHD because of its association with life threatening
hepatic failure. 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. The product
labeling for Cylert was modified to include a boxed warning describing
liver failure and to indicate that Cylert should not ordinarily be considered
as first line drug therapy for Attention Deficit Hyperactivity Disorder
(ADHD).
Since Cylert's marketing in 1975, 13 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.
Of the 13 reported cases, 11 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.
It is also not clear if the recommended baseline and periodic liver function
testing are predictive of these instances of acute liver failure. Cylert
should be discontinued if clinically significant hepatic dysfunction is
observed during its use.
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