USA. The US Food and Drug Administration (FDA) has asked Pfizer and 13 other manufacturers of anti-epilepsy drugs to re-examine their clinical trial data for evidence of increased drug-induced suicide and/or suicidality. The 14 companies have been asked to re-analyse their clinical trials data in six months after which the FDA will conduct final analyses. The FDA has advised the re-analysis following some signals that were observed in controlled trial databases for currently marketed anticonvulsants and due to postmarketing concerns of suicides by patients taking gabapentin (Neurontin), an anti-epilepsy preparation that is marketed in the US.
Scrip World Pharmaceuticals News No. 3050, 29 April 2005 (http://www.scrippharma.com).