Drug Warnings That Can Cause Fits — Communicating Risks in a Data-Poor Environment
- 4 September 2008
- journal article
- Published by Massachusetts Medical Society in New England Journal of Medicine
- Vol. 359 (10) , 991-994
- https://doi.org/10.1056/nejmp0805922
Abstract
In 2005, after receiving case reports of suicides by patients taking anticonvulsant medications, the Food and Drug Administration (FDA) asked the manufacturers of 11 drugs in this class to report all suicide-related events in the controlled trials they had conducted over many years. This past January, nearly 3 years later, the agency completed its analysis of these data and announced that it had found a near-doubling of suicidal ideation and behavior among trial subjects randomly assigned to receive these drugs rather than placebo1 (odds ratio, 1.8; 95% confidence interval [CI], 1.2 to 2.72). For patients in epilepsy studies, the . . .Keywords
This publication has 0 references indexed in Scilit: