Recent regulatory changes in antidepressant labels: Implications for activation (stimulation)
with Peter R. Breggin M.D.
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.
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
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. fdapressconfsept142004.pdf
A report Dr. Breggin presented to the FDA in August 2004 detailing the relation of suicidality and violence to antidepressants fdaaug2304.pdf
Dangers of antidepressants. Newspaper column–shortened.pdf
SSRIs produce a continuum of stimulation that includes manic-like reactions, agitated depression, obsessive preoccupations, and akathisia. FDAspeech2.2.04.pdf
Information on antidepressant-induced akathisia comes to light with court filing in Lacuzong case. courtfiling.pbreggin.2006.pdf
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
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. Peter Breggins Paxil Special […]