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News of the Day ... in Perspective

3/26/2004

FDA issues public health advisory on suicide risk of antidepressants

The FDA has advised physicians, patients, and caregivers to watch closely for suicidal ideation in patients given selective serotonin reuptake inhibitors (SSRIs), especially early in the course of treatment or when dosage is changed.

The Agency also advises monitoring for anxiety, agitation, panic attacks, irritability, hostility, restlessness, and hypomania, and warns of the special need for vigilance in patients with bipolar disorders (FDA Talk Paper 3/22/04).

The Agency stopped short of a clear and unambiguous warning about “toxic behavior” – sudden violent, uncontrolled outbursts, complained the Alliance for Human Research Protection (www.ahrp.org).

The FDA’s action follows impassioned public testimony at a February 2 hearing that blamed the drugs for suicides and other adverse effects. Consumer advocates say that data from clinical trials has been suppressed.

British regulators have warned physicians not to prescribe any SSRI except fluoxetine (Prozac) for depressed youth younger than 18.

The FDA is asking manufacturers to include stronger warnings on the labels of ten drugs.

Additional information:

Transcript of Feb. 2 FDA hearing: http://www.fda.gov/ohrms/dockets/ac/04/transcripts/4006T1.htm

Forced drugging of prisoners. AAPS News, May 2002

AAPS amicus brief and other legal documents in U.S. v. Sell: www.aapsonline.org/judicial/sell.htm.

Compulsory drugging of schoolchildren. AAPS News, Jan. 2001; Medical Sentinel, Spring 2001

News of the Day Archive