Executive Summary

PROZAC/ANTIDEPRESSANTS' SUICIDAL IDEATION POTENTIAL will be discussed by FDA's Psychopharmacological Drugs Advisory Committee "in late summer or early fall," FDA Division of Neuropharmacological Drug Products Director Paul Leber, MD, said in a June 21 letter sent out to all manufacturers of antidepressant drugs. "Recent media reports have called attention to the risk of suicidal ideation/behavior associated with the pharmacological treatment of depression," Leber noted. "While these reports have focused on events occuring in association with (BRACKET)Lilly's(BRACKET) Prozac (fluoxetine hydrochloride), the issue is actually a generic one affecting all antidepressant drug products." The FDAer pointed out that "because there has been no neutral forum in which to evaluate the subject, we thought it would useful to bring this issue to our Psychopharmacological Drugs Advisory Committee for their consideration." Leber added that FDA is notifying all manufacturers of antidepressants of the meeting since "this discussion is likely to have implications for labeling of antidepressant drug products." The meeting has not yet been scheduled. "When the date is set, a notice will appear in the (ITALICS)Federal Register,(END ITALICS)" Leber said. He advised the companies to inform FDA as soon as possible whether they intend to make presentations at the meeting or wish to provide materials to the committee prior to the meeting. Lilly said it is "delighted" and "enthusiastic" about the meeting. "It's exactly what is needed at this point," a Lilly spokesperson said. Commenting on the media coverage of reports of Prozac being associated with suicidal thoughts, the spokesperson said that "there's been too much misinformation circulated in the last year and a half." The company believes that "this FDA action will clear the air of this misinformation." Prozac has been the focal point of an intense public relations campaign by the Church of Scientology, which is opposed to all use of psychopharmacologic agents. Lilly said it plans to present clinical trial data and information addressing the question of suicidal tendencies at the advisory committee meeting. Included in the Lilly data package will be an analysis of over 3,000 patients who participated in the company's clinical trials -- of that group, approximately one-third had experienced suicidal thoughts prior to entering the studies. The patient group in the analysis includes patients who received either Prozac, placebo or a tricyclic antidepressant in the trials. At the end of the trials, Lilly said, the patients on Prozac had "a statistically significant far less emergence of suicidal thinking than either" of the other groups. The analysis has been submitted to a peer review publication.