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PROZAC BOXED LABEL WARNING FOR SUICIDAL THOUGHTS

Executive Summary

PROZAC BOXED LABEL WARNING FOR SUICIDAL THOUGHTS is expected to be proposed by Public Citizen's Health Research Group later in May. HRG plans to petition FDA that a box warning concerning a potential for suicidal preoccupation be added to the labeling for Lilly's antidepressant Prozac. The proposed label warning, which appeared in an article in HRG's May Health Letter, notes that: "A small minority of persons taking Prozac (fluoxetine) have experienced intense, violent, suicidal thoughts, agitation and impulsivity." The proposed warning continues: "Some of the people involved had no prior history of depression or suicidal thoughts, and were being treated with fluoxetine for other problems (e.g. obsessive- compulsive disorder). Whether development of such symptoms is coincidental or drug-related is still under investigation." The proposed statement emphasizes that "Prozac should only be used under careful medical supervision, and patients are advised to alert relatives and friends to their use of Prozac and the risk of suicidal obsession." HRG said it will petition FDA for inclusion of the label warning "in order to reach more patients and physicians with this important information." The health advocacy group said that reported cases of suicidal preoccupation in patients taking Prozac have been increasing since the drug became available. Lilly, defending Prozac's nearly four-year history of more than 3.5 mil. patients treated, called the proposed warning label "utterly without merit. The approved labeling for Prozac is consistent with current medical and scientific information," Lilly stated. "No additional warnings are needed." The company added that "there is no credible evidence in the medical literature that Prozac causes increased suicidal thinking or suicidal actions." ABC News' "PrimeTime Live" addressed allegations that Prozac is the cause of suicide attempts and violent behavior, including murder in a May 9 segment. PrimeTime Live is the latest network TV news show to discuss Prozac in the past few weeks. The segments all have focused on a new legal argument, the so-called "Prozac defense," in which attorneys have argued that their clients' violent or homicidal actions were the result of Prozac therapy. In a prepared statement, Lilly said that in each of the six criminal cases in which defense attorneys blamed Prozac for clients' actions, "juries have convicted the accused and rejected the claim that Prozac was responsible for the defendant's criminal acts." Lilly noted that on May 8, Philadelphia Federal Court Judge Robert Kelly "approved the voluntary dismissal of a civil suit against" Lilly that alleged Prozac caused plaintiff Richard Howden's wife to commit suicide. "The Howden case is the third civil case against Prozac to be dismissed thus far," Lilly added. Harvard professor and psychopharmacologist Martin Teicher, MD, who has testified in one murder case where the defendant was on Prozac and who is expected to testify in the appeals case of another man convicted of murdering his wife, professed his skepticism for the "Prozac defense" on the program. Teicher suggested that the "bulk of the claims" represent "an act of desperation on the part of the lawyer." However, Teicher added: "I think in some of the claims, Prozac simply energized patients to act in a way they may well have acted anyway, and I think in some of [the cases], Prozac did produce a state of mania or a state of paranoia . . ." Teicher reported in The American Journal of Psychiatry that a case study of 172 hospital patients treated for depression with Prozac found that six patients had "intense suicidal preoccupation" when they were given 80 mg of Prozac per day, the maximum dose recommended. The average dose of Prozac is 20 mg/day. However, Teicher suggested that some mention in labeling may be warranted. "Even if we saw this occur in one patient, it's medically significant to point this out as a side effect," Teicher said on "PrimeTime Live. In recent weeks, Lilly has adopted a more aggressive posture in publicly defending Prozac. Lilly Group VP Leigh Thompson, MD/PhD, appearing on the ABC news segment, stated that "violence and suicide are a problem with depression. They're not a problem caused by Prozac." The program pointed out that 2% of patients treated for depression exhibit violent or suicidal behavior.
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