FDA Alert Re Cylert, a drug used to treat ADHD. Coming a mere 10 years after Canada and Great Britain pulled the drug from their markets and and 5 months after the manufacturer, Abbott Labs, stopped making and marketing the drug due to declining sales, the question is why did the FDA bother at all.
Does anyone need more evidence that the FDA is dysfunctional? Exhibit A: its recent Alert about Cylert, a drug used in the treatment of Attention Deficit Hyperactivity Disorder (ADHD). Coming a mere 10 years after Canada and Great Britain pulled the drug from their markets and 5 months after the manufacturer, Abbott Labs, stopped making and marketing the drug due to declining sales, the question is why did the FDA bother at all.
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).
The rest of the story from Chicago Injury Law Blog:
Cylert Withdrawn From Marketplace Due To Liver Toxicity
The FDA announced today that Cylert, and all similar generics, be removed from the market. Cylert, made by Abbott Laboratories, is a treatment drug for ADHD on the market since the 1970’s.
In 1995, Canada and Great Britian removed the drug from their respective markets citing a study that indicated a 45 fold increase in childrens’ liver failure. The FDA did not force the withdrawal, and the drug remained on the market for another 10 years.
Abbott Labs stopped marketing and making the drug in May, 2005, citing declining sales.
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