Rep. Hinchey Calls On FDA To Investigate Agency Knowledge Of Prozac Data
This article was originally published in The Pink Sheet Daily
Executive Summary
Rep. Maurice Hinchey (D-N.Y.) requests that FDA conduct an investigation into what the agency did or did not know about Lilly documents regarding a possible link between Prozac (fluoxetine) and increased suicidality and violence
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Rep. Maurice Hinchey (D-N.Y.) requests that FDA conduct an investigation into what the agency did or did not know about Lilly documents regarding a possible link between Prozac (fluoxetine) and increased suicidality and violence. The documents, discussed in a Jan. 1 issue of the British Medical Journal, reportedly went missing during a 1994 case stemming from a murder involving a suspect who was placed on Prozac one month before the shootings (1 (Also see "“Missing” Lilly Documents Under Review By Rep. Hinchey" - Pink Sheet, 3 Jan, 2005.)). In a Jan. 5 2 letter to FDA, Hinchey asks, "Did FDA have every single one of the Eli Lilly documents regarding Prozac that BMJ provided recently to your agency and was it aware of all the issues raised in those documents?" "If yes, what was the FDA's response to the information contained in these Eli Lilly documents, in particular the 38% activation rate?" BMJ asserted that a study finding 38% of fluoxetine-treated patients reported new activation compared to 19% of placebo-treated patients had never been released by the company. Lilly refuted the claim Jan. 5 (see 3 (Also see "Prozac Documents Deemed "Missing" Were Already Available, Lilly Says" - Pink Sheet, 5 Jan, 2005.)). "Was FDA aware of the adverse event reports denoting significantly higher suicide and violent act rates for Prozac than those of other commonly used antidepressants in the mid 1980s and early 1990s?" Hinchey asks. Lilly noted that labeling for Prozac reflects information on suicidality and activation. 4 Labeling states, "Patients being treated with antidepressants should be observed closely for clinical worsening and suicidality." "The following symptoms, anxiety, agitation, panic attacks, insomnia, irritability, hostility…have been reported in adult and pediatric patients being treated with antidepressants." The Hinchey letter states, "It is important to note that the documents in question were uncovered during the discovery process of product liability lawsuits like those your former Chief Counsel, Daniel Troy, had sought to shut down,". Hinchey sponsored an amendment to the FDA appropriations bill that would have removed $500,000 from the Office of the Commissioner, intended to cut the budget of the Office of Chief Counsel (5 (Also see "FDA Approps Amendment Targets Chief Counsel Troy; Pfizer Ties Challenged" - Pink Sheet, 14 Jul, 2004.)). Hinchey accused then-FDA Chief Counsel Troy of having a cozy relationship with industry, citing in particular FDA's filing of an amicus brief in a lawsuit brought against Zoloft marketer Pfizer. FDA is requesting that labeling for antidepressants add a "black box" warning regarding suicidality in children and adolescents (6 (Also see "FDA Antidepressant Safety Plan Includes "Black Box," Unit-Of-Use Packaging" - Pink Sheet, 15 Oct, 2004.)). - Andrew Shelton |