Topamax (Topiramte) for Bipolar: Florida settles with maker of Topamax
by Sarah from Bipolar-Lives
(FL, US)
The maker of Topamax (an anti-convulsant medication drug used to treat epilepsy) will pay Florida $3 million to settle allegations it marketed the drug for other conditions, including bipolar disorder. The settlement arose out of allegations that the manufacturers of Topamax marketed the drug for uses (such as treating bipolar disorder) not approved by the FDA.
FROM Wikipedia:
"Psychiatrists have used topiramate to treat bipolar disorder, and often use topiramate to augment psychotrophics or counteract weight gain associated with numerous antidepressants. However, a 2006 Cochrane review concluded that there is insufficient evidence on which to base any recommendations regarding the use of topiramate in any phase of bipolar illness. On May 21, 2010, Ortho-McNeil plead guilty and was fined US$6.14 million by the FDA for promoting Topamax to treat psychiatric disorders, without applying for any approval and there was no data from any well-controlled clinical trial to demonstrate that Topamax was safe and effective to treat any psychiatric conditions."