Cylert Side Effects and Risks
Cylert was used to treat Attention Deficit Hyperactivity Disorder (ADHD), primarily in children, for 30 years before it was banned by the FDA (Federal Drug Administration) in October 2005. Cylert was manufactured by Abbott Laboratories, but the same medication was also manufactured by other companies under the generic name pemoline.
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The FDA required a black-box warning about liver damage on Cylert in 1999. Sales dropped and other drugs with less serious side effects were used to treat most cases diagnosed as ADHD. When the FDA received a report of another case of liver failure, for a total of 13 reported cases, it met with Abbott and the company decided to stop manufacturing the drug in May 2005. Companies manufacturing the generic products agreed to stop manufacture as well because of the serious Cylert risk.
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. The FDA said:
FDA is 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.
The FDA’s handling of Cylert has been controversial, because Canada and Great Britain took Cylert off the market in those countries in 1995, while the FDA opted to increase the level of warning but allowed the drug to stay on the market. The consumer advocacy group Public Citizen petitioned the FDA in 2005 to ban the sale of Cylert and other pemoline products.
Check out the following articles for more information about Cylert, filing a Cylert lawsuit and finding a Cylert attorney.
Suffered harm from Cylert? You may have a lawsuit. Click here, for a top rated law firm to evaluate your legal rights. |