Harvard Mental Health Letter

Antidepressants and suicide

The history of a controversy — and where it stands today.

An often bitter dispute about the risks of antidepressant drug use peaked at an emotional 2004 FDA hearing. It may be coming to a tentative resolution with new recommendations for prescription labeling and further analysis of surveys and clinical trials. The story provides some lessons on the difficulty of making decisions about drug regulation in a context of political controversy and the complications involved in balancing risks and benefits when prescribing psychiatric drugs.

In 1990, Harvard researchers reported that six patients had developed intense and violent suicidal preoccupations soon after starting to take fluoxetine (Prozac), which had been approved for the treatment of depression only two years earlier — the first of the now famous selective serotonin reuptake inhibitors (SSRIs). An FDA expert panel found no evidence for a serious risk in its analysis of clinical trials comparing fluoxetine to a placebo.

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