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 (2008), 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 (2008) and Medication Madness (2008).  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. [link to SSRI antidepressants under Psychopharmacology section].  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. 

DocumentsDate added

Order by : Name | Date | Hits [ Descendent ]
file icon Antidepressant-induced suicidality and violence: more about deception than science 01/15/1993
Report presented at the September 14, 2004 press conference sponsored by the Alliance for Human Research Protection (AHRP) at the FDA Public Hearing on Antidepressants and Suicide.
file icon Court filing makes public my previously suppressed analysis of Paxil's effects 01/14/2003
Information on antidepressant-induced akathisia comes to light with court filing in Lacuzong case.
file icon Drug Company Suppressed Data on Paroxetine-Induced Stimulation 01/12/2001

Paxil Special Report III: The third special report in a series providing excerpts from Dr. Breggin's 1999 product liability report in the CA case of Lacuzong v. GlaxoSmithKline, alleging that Paxil (paroxetine) caused a double murder and suicide. Ethical Human Psychology and Psychiatry 8 (2006) 255-263.

file icon Fluvoxamine as a cause of stimulation, mania and aggression with a critical analysis of the FDA-apro 01/15/1990

"Fluvoxamine as a cause of stimulation, mania and aggression with a critical analysis of the FDA-approved label," International Journal of Risk and Safety in Medicine 14 (2001) 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.

file icon Proven dangers of antidepressants 01/12/1992
Dangers of antidepressants.
file icon Recent regulatory changes in antidepressant labels: Implications for activation (stimulation) 06/09/2008
file icon Recent U.S., Canadian and British regulatory agency actions concerning antidepressant-induced harm 06/09/2008
file icon Speech to FDA Panel, 2 Feb 2004 01/12/1995
SSRIs produce a continuum of stimulation that includes manic-like reactions, agitated depression, obsessive preoccupations, and akathisia.
file icon Suicidality, violence and mania caused by selective serotonin reuptake inhibitors (SSRIs): A review 01/12/2005

Evidence from many sources confirm SSRIs commonly cause or exacerbate a wide range of abnormal mental and behavioral conditions. International Journal of Risk & Safety in Medicine 16 (2003/2004) 31-49.

file icon The Eli Lilly Prozac Suicide and Violence Documents: An Analysis 01/01/1996
An analysis of Eli Lilly documents linking Prozac to suicide and violence
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Most psychiatric drugs can cause withdrawal reactions, sometimes including life-threatening emotional and physical withdrawal problems. In short, it is not only dangerous to start taking psychiatric drugs, it can also be dangerous to stop them. Withdrawal from psychiatric drugs should be done carefully under experienced clinical supervision. Methods for safely withdrawing from psychiatric drugs are discussed in Dr. Breggin's new book, Psychiatric Drug Withdrawal: A Guide for Prescribers, Therapists, Patients, and Their Families.