FDA overhauls trial design with new suicide standard

The FDA has quietly engineered the biggest change-up in the way many clinical trials are designed since the early '90s. Developers working in a range of fields including obesity, epilepsy, smoking cessation, depression and more are being required to investigate the added risk of suicide. Merck, Sanofi-Aventis and Eli Lilly are all adding suicide assessments to trials, as the FDA notifies developers of the new trial standard.

The new requirement has been in the works for several years, starting with startling indications four years ago that antidepressants increased suicide risks among children and teenagers. The New York Times adds that fresh alarm bells were rung by Acomplia [1], an obesity drug from Sanofi-Aventis also linked to psychiatric side effects.

- read the report [2] from The New York Times

Related Articles:
Suicide stats fuel debate over SSRI drugs [3]
Child suicide rise tied to FDA warnings [4]
Study highlights link between Paxil and suicide [5]
Sanofi shares slide as FDA delays Acomplia-again [1]