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FDA DENIES HRG’s PROZAC BOXED WARNING LABEL PETITION

Executive Summary

FDA DENIES HRG's PROZAC BOXED WARNING LABEL PETITION because "evidence is not sufficient to reasonably conclude that the use of [Lilly's] Prozac is possibly associated with suicidal ideation and behavior (suicidality)," FDA said in a June 3 letter. The Health Research Group submitted a May 23, 1991 citizen's petition requesting that FDA include in the antidepressant's labeling a boxed warning on the drug's alleged association with suicidal preoccupation, agitation and impulsivity in "a small minority of patients" ("The Pink Sheet" May 27, 1991, T&G-16). Center for Drug Evaluation and Research Director Carl Peck, MD, told HRG that "upon analyzing the case reports, clinical trials, conclusions of the [Psychopharmacological Drugs Advisory Committee], and other relevant evidence, we have concluded that a change in labeling is not warranted at this time." The "case reports of patients who experienced suicidal ideation while undergoing Prozac treatment are inconclusive," Peck wrote HRG, adding that "it is impossible in individual cases to conclude that suicidality was caused by the drug as opposed to the illness being treated." At its Sept. 20, 1991 meeting, the advisory committee determined that evidence was insufficient to link Prozac or other antidepressants with suicidality or violent behaviors ("The Pink Sheet" Sept. 23, 1991, p. 3). Data from FDA's Spontaneous Reporting System "are also inconclusive at this time," Peck noted. "While there are a significant number of drug experience [reports] pertaining to Prozac, there are numerous factors potentially contributing to this number." The reports are "at most a signal of the need for further investigation into the issue of an association between Prozac and suicidality." FDA will "continue our careful evaluation of data in our spontaneous reporting system and encourage additional research on this matter. If further research or our SRS discloses reasonable evidence of an association, we will take all necessary steps to protect the public health."
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