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FDA Information

Pemoline was approved by the FDA for the treatment of ADHD on January 27th 1975.

Pemoline has some advantages over other stimulants in that it does not reduce the appetite or cause dry mouth. However, in some patients pemoline is suspected of causing liver damage, so regular liver tests are performed on those treated with it.

However, since receiving FDA approval, it has been linked with 21 cases of liver failure, of which 13 resulted in liver replacement or death. As a result, Abbott Laboratories announced in March 2005 that Cylert® (pemoline) would no longer be available in the United States, and in October 2005 manufacturers of generic pemoline agreed to stop sales and marketing of these products. This action was based on advice from the FDA, who stated that the overall risk of liver toxicity with pemoline outweighs the benefits of the drug. The FDA's withdrawl of pemoline was also due to pressure from certain public advocacy groups, including Public Citizen.

On the other hand, the patient support group Narcolepsy Network, tried to persuade the FDA not to ban it, on the grounds that some patients find all other treatments ineffective or to have dehabilitating side effects. This medication was used by an estimated 10,000 Americans afflicted with narcolepsy.

If you are currently taking pemoline, you should call your doctor to discuss switching to another treatment. Please visit the official site of the FDA for further information.


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