The FDA: Articles, Critiques and Presentations

Dr. Breggin’s work has helped to change the contents of numerous FDA-approved labels for psychiatric drugs, including the neuroleptic (antipsychotic) drugs and the newer antidepressants. This section makes available some of Dr. Breggin’s articles about recent label changes for the antidepressants, as well his critiques and presentations to the FDA.

Dr. Breggin’s commentaries in this section surround the FDA’s actions in adding suicidality in children and young adults to the labels for antidepressants.  The language in the new FDA-mandated labels closely adheres to concepts first published in Dr. Breggin’s earlier books and articles concerning suicide, violence, and over-stimulation caused by SSRIs.  As described in the first commentary, the FDA’s language seems to mimic his wording. 

For the science behind these commentaries, see Dr. Breggin’s book, Brain-Disabling Treatments in Psychiatry, Second Edition, as well as his scientific articles.  In several of his books, Dr. Breggin devotes chapters to the inadequacy of the FDA, most recently Brain-Disabling Treatments in Psychiatry, Second Edition and Medication Madness.  One of the most detailed analyses ever published of the FDA’s bungling and a drug company’s manipulation of the drug approval process can be found in Talking Back to Prozac (with Ginger Breggin, 2004).

Dr. Breggin’s published articles on SSRI antidepressants, including medication-induced violence, suicide and crime, often discuss the FDA.  His article “Suicidality, violence and mania caused by selective serotonin reuptake inhibitors (SSRIs): A review and analysis” was given to the FDA’s committee prior to their deliberations.

The following section contains articles and commentaries by Dr. Breggin concerning the FDA, especially in regard to the newer antidepressants. 

Suicidality, violence and mania caused by selective serotonin reuptake inhibitors (SSRIs): A review and analysis (2004)

Breggin, P.R. International Journal of Risk and Safety in Medicine 16 (2003/2004). Evidence from many sources confirms that selective serotonin reuptake inhibitors (SSRIs) comonly cause or exacerbate a wide range of abnormal mental and behavioral conditions. suicidalityviolence.pbreggin.2003.pdf

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Fluvoxamine as a cause of stimulation, mania and aggression with a critical analysis of the FDA-approved label (2001)

Breggin, PR. (2001) International Journal of Risk and Safety in Medicine, 14, 71-86. A comparison of the FDA-approved label for Luvox (fluvoxamine) with the known risks of fluvoxamine-induced stimulation, mania and aggression in adults and children. fluvoxamine.pdf

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