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Re: new fda drug safety update site - Gabitril

Posted by SLS on June 10, 2005, at 8:18:23

In reply to new fda drug safety update site, posted by River1924 on June 10, 2005, at 0:27:14

> http://www.fda.gov/cder/drug/drugsafety/DrugIndex.htm

Great page!

Among other things:

"FDA ALERT [02/18/2005] – Seizures in Patients Without Epilepsy
Today the Food and Drug Administration announced that a bolded Warning will be added to the labeling for Gabitril (tiagabine) to warn prescribers of the risk of seizures in patients without epilepsy being treated with this drug. Although Gabitril has been shown to reduce the frequency of seizures in patients with epilepsy, paradoxically, Gabitril’s use has been associated with the occurrence of seizures in patients without epilepsy. Gabitril is approved for use only as adjunctive therapy in adults and children 12 years and older in the treatment of partial seizures. Because Gabitril has not been systematically evaluated in adequate and well-controlled trials for any other indication, its safety and effectiveness have not been established for any other use.

Cephalon will undertake an educational campaign to discourage off-label use of Gabitril."

I never liked this drug.


- Scott

 

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poster:SLS thread:510366
URL: http://www.dr-bob.org/babble/20050606/msgs/510446.html