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Subscribe To Our Syndicated NewsFDA Withdrawals ADHD Drug
November 2, 2005
The FDA has announced the recall of all generic forms of the ADHD drug pemoline. This ADHD drug was originally manufactured by Abbott under the name Cylert. Abbott took Cylert off the market in May of 2005. While the company cited financial concerns as their reason to withdrawal Cylert, there were also severe side effects associated with the drug. Consumer watchdog group, Public Citizen, and other organizations have pressured the FDA to recall all pemoline products as a result of serious potential liver complications.
ADHD, attention deficit hyperactivity disorder, is a condition of the brain which causes a child to have trouble controlling their behavior. The American Academy of Pediatrics estimates that between four and twelve percent of all school-aged children have ADHD. There are many drugs available to treat children with ADHD. Cylert and other generic forms of pemoline have been available for many years.
Since 1999, these ADHD drugs have carried black box warnings about the serious risk of live problems associated with pemoline medications. The FDA has received reports of 13 liver failure cases leading to liver transplant or death, as a result of taking Cylert or generic pemoline. At least another eight cases of liver failure have been linked to use of Cylert. According to the FDA, the risk of developing liver failure is ten to twenty-five times greater in people taking Cylert, compared to the general population. The agency has concluded that the risks associated with this medication far outweigh its intended benefits.
Public Citizen petitioned the FDA in March 2005 to recall Cylert and all generic forms of the drug. Though Cylert was recalled in May 2005, the generic pemoline was allowed to remain on the market. In recent months, the FDA has urged doctors to prescribe alternative treatments for ADHD. For patients already taking Cylert or its generics, the FDA advised that they be switched to another medication.
The FDA has now ordered the termination of all pemoline manufacturing. The remaining supplies of this drug can be sold, but no new product will be manufactured and distributed. Doctors have been told to seek alternative treatments for their patients. If your child is taking a pemoline drug, it is wise to speak with your doctor to discuss treatment options.
For more information on Cylert side effect, please contact us to confer with a Cylert Lawyer and learn your legal rights and options.
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