Suicidality from fluoxetine

Bouchy, C. (1990a, November 13). Memo to Leigh Thompson, A. Weinstein, andR. Zerbe, with copies to M. Gerhard, T. Sidney and H. Weber. Re Adverse drug event reporting— Suicide fluoxetine. Retrieved from http //www.breggin.com... 

An unpublished document obtained during discovery in product liability suits against the drug company disclosed that Eli Lilly, the manufacturer of fluoxetine (Prozac), had evaluated the comparative rates of suicide attempts on fluoxetine, amitriptyline, and placebo (the documents are available from http //www.breggin.com). The data were generated during controlled clinical trials conducted for the FDA approval process for Prozac for depression. On the basis of the company s data for controlled clinical trials, patients taking fluoxetine were 12 times more... 

Muijen et al. (1988) conducted a 6-week double-blind study comparing fluoxetine, mianserin, and placebo with 26, 27, and 28 starters, respectively, and 14, 14, and 16 finishers, respectively. Two of the fluoxetine patients took an overdose within two weeks of starting the study, and in both cases this was related to a deteriorating clinical state that necessitated hospitalization (p. 386). None of the patients in the other drug group or the placebo group suffered from this decline and suicidality. 

Masand et al. (1991) reported on two cases of suicidality in association with fluoxetine. One of the patients suffered from akathisia. In both cases, the suicidal feelings subsided shortly after stopping the medication. Neither patient had prior suicidal ideation. Both developed violent fantasies (hanging and jumping out a window). 

In an analysis of data from the National Institute of Mental Health Collaborative Depression Study in 643 patients with affective disorders who were followed up after fluoxetine was approved by the FDA in December 1987 for the treatment of depression, nearly 30% (n = 185) took fluoxetine at some point (18). There was an increased rate of suicide attempts before fluoxetine treatment in those who subsequently took fluoxetine. Relative to no treatment, fluoxetine and other antidepressants were associated with non-significant reductions in the likelihood of suicide attempts or completions. Severity of psychopathology was strongly associated with increased risk, and each suicide attempt after admission to the study was associated with a marginally significant increase in the risk of suicidal behavior. The authors concluded that the results did not support the speculation that fluoxetine increases the risk of suicide. 

Fluoxetine and other selective serotonin reuptake inhibitors (SSRIs) have been associated with increasing suicidal ideation in some populations of patients. Recent studies have led the British Department of Health to warn physicians against using paroxetine off label. Fluoxetine was specifically exempted from this recommendation. Long-term studies of patients with depression who were treated with fluoxetine have shown it to be fairly well tolerated. Primary adverse effects include nausea (23%), headache (21%), and insomnia (20%). 

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