CONGRESSMAN CALLS FOR PROBE OF FDA's KNOWLEDGE OF PROZAC RISKS
A Democratic congressman has asked the FDA to investigate what it knew about certain Eli Lilly documents from the mid-1980s that allegedly showed a link between suicidal behavior and the antidepressant Prozac.
The documents, which came to light in the Jan. 1 issue of the British Medical Journal (BMJ), raise several critical questions about what the FDA and Eli Lilly may have known about a potential relationship between Prozac (fluoxetine) and increased suicidality 13 or more years ago, according to a letter from Rep. Maurice Hinchey (D-N.Y.) to acting FDA Commissioner Lester Crawford.
The documents include adverse event reports that indicate Prozac may have had far higher rates of suicide and violent acts than those for four commonly used antidepressants in the 1980s and early 1990s, Hinchey said. According to one adverse event report, 3.7 percent of Prozac reports -- totaling 14,198 reports -- were suicide attempts, he said. This rate was nearly five times higher than that of the drug Amitriptyline (elavil), which had the next highest suicide rate, as well as 12 and 18 times the rate of two other products, he said.
Another Lilly document, titled "Activation and Sedation in Fluoxetine Clinical Trials," describes how Prozac had an activation rate of 38 percent - twice that of a placebo, Hinchey noted. The increased activation rate recently has been considered a cause for increased suicidality, he said.
To view a copy of Hinchey's letter, go to http://www.house.gov/apps/list/press/ny22_hinchey/morenews/010605fdaprozac.html (http://www.house.gov/apps/list/press/ny22_hinchey/morenews/010605fdaprozac.html).