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Case ID: 4503 | Drugs / Medical | 10/24/2005
The 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 (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. 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. Despite diminished use of Cylert and generic pemoline products since the addition of the boxed warning in 1999 (about 1/5 the number of prescriptions now compared to before the boxed warning) and restrictive labeling (e.g., boxed warning, second line therapy, Medication Guide), a risk of liver failure remains (FDA is aware of 1 new case of pemoline-associated liver failure since the introduction of the boxed warning in 1999). Given the availability of multiple other drug treatments for ADHD, including 1 that is not scheduled and several products that can be given once a day, FDA has concluded that the risk of liver failure with this drug outweighs the potential benefits. If you or a loved one suffered liver failure or liver complications while on Cylert, our lawyers may be able to help you. At Lawcash.com, it is our goal to keep you informed about important legal cases, class actions and settlements. Our lawyers offer free legal evaluations in tort cases, class actions, personal injury, and other lawsuits because we are dedicated to helping you resolve your legal complaints. Other Drugs / Medical Cases of Interest An administrative proceeding has been filed against Smart Inventions, Inc., a California-based direct response TV company, and its Chief Operating Officer, Jon D. Nokes, by the Federal Trade Commission on behalf of persons who purchased “Biotape,” a tape-like substance promoted to treat or cure severe pain. The action alleges that there is no substantial evidence that the product relieves pain, and that the advertisements violate the FTC Act because they are false and misleading. Medicaid helps lower-income families pay for medical expenses that they have no way of covering. Judgment has been entered against the Indiana Family and Social Services Administration on behalf of the families of certain mentally ill children forcing the administration to pay for the children's long-term care in residential institutions. The judgment will not be final until all possible appeals deadlines have passed.
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