FDAnews
www.fdanews.com/articles/67786-lilly-defends-against-prozac-allegations

LILLY DEFENDS AGAINST PROZAC ALLEGATIONS

January 20, 2005

Eli Lilly has launched an initiative to correct what it says are inaccurate statements made about the company and its antidepressant Prozac in a prominent British medical journal and other media.

The company's move is in response to a Jan. 1 story by the British Medical Journal (BMJ), which suggested that Lilly may have known about a potential relationship between Prozac (fluoxetine) and increased suicidality 13 or more years ago. The article alleged that certain documents related to the increased risks "went missing" during a 1994 product liability lawsuit. Rep. Maurice Hinchey (D-N.Y.) asked the FDA to initiate an investigation into the matter.

The article published by BMJ and subsequent articles from various media contain false allegations regarding disclosure about important Prozac safety information as well as misleading and scientifically invalid conclusions about Prozac data, according to Lilly.

"Lilly has always been forthcoming with safety data," said Alan Breier, vice president and chief medical officer at Lilly. "This particular information has been shared with regulators and publicly discussed by experts, with conclusions supporting Prozac's safety." Lilly also said it was in discussions with the FDA, Hinchey and BMJ to resolve the situation. For more information, go to http://www.lilly.com (http://www.lilly.com).