Dangerous Drug Recalled: Cylert

Generic name: Pemoline

Manufactured and marketed by: Abbott Laboratories

Purpose: It was prescribed to treat Attention Deficit Hyperactivity Disorder (ADHA), primarily in children.

Recall: In October 2005, the FDA issued a formal ban on the product, concluding that the risk of liver damage was greater than the benefit of treating ADHD, since other, safer drugs were available. Furthermore, they were a aware of 13 reports of liver failure resulting in liver transplant or death, usually within four weeks of onset of signs and symptoms of liver failure. Although the absolute number of reported cases of liver failure with pemoline is not large, the reporting rate for liver failure with pemoline is 10 to 25 times greater than the background rate of liver failure in the general population.

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Side Effects Reported

• There have been reports of hepatic dysfunction, ranging from asymptomatic reversible increases in liver enzymes to hepatitis, jaundice and fatal hepatic failure, in patients taking Cylert.
• There have been isolated reports of aplastic anemia.
• The following CNS effects have been reported with the use of Cylert: convulsive seizures; hallucinations; dyskinetic movements of the tongue, lips, face and extremities; abnormal oculomotor function including nystagmus and oculogyric crisis; mild depression; dizziness; increased irritability; headache; and drowsiness.
• Insomnia is the most frequently reported side effect of Cylert; it usually occurs early in therapy prior to an optimum therapeutic response. In the majority of cases it is transient in nature or responds to a reduction in dosage.
• Anorexia and weight loss may occur during the first weeks of therapy. In the majority of cases it is transient in nature; weight gain usually resumes within three to six months.
• Nausea and stomach ache have also been reported.

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