Violence, Murder, Suicide and Antidepressant Drugs
Long term use of medications increases the risk of toxic side effects.
In the case of antidepressant drugs, these side effects can be lethal.
Whenever I hear a news report of someone injuring themselves or others by a senseless act of violence or suicide, I wonder if they were taking an antidepressant drug. Carol Ann Gotbaum strangled herself on 9-28-07, shortly after being arrested by Phoenix police for causing a disturbance at the airport. An autopsy reported the antidepressant drugs, Citalopram (Celexa), and Duloxetine (Cymbalta) in her blood. and urine (see http://gothamist.com/2007/11/10/carol_gotbaum_a.php). (The names and types of her medications, and the link to the autopsy report have since been removed.)
Antidepressant drugs are believed to be a common factor in many school shootings, including Columbine High School and Virginia Tech; schools designated as "drug free zones". The list of murder, suicide and threats or acts of violence believed to be associated with antidepressant drugs grows daily, including ten in the U.S. in the nine days following the VA Tech massacre, 4-16-07.
John W. Cartmell, MS
School Shootings Associated Worldwide with
The Food and Drug Administration (FDA) has asked manufacturers of the following antidepressant drugs to include in their labeling a warning recommending close observation of adult and pediatric patients treated with these agents for any worsening depression or emergence of suicidal tendencies.
FDA Public Health Advisory, March 22, 2004
Worsening Depression and Suicidality in Patients Being Treated With Antidepressants
FDA - Serious Risks, October 2004"In October 2004, FDA directed manufacturers to add a boxed warning to the labeling of all antidepressant medications to alert the public about the increased risk of suicidal thinking or suicide attempts by children and adolescents taking antidepressants. A boxed warning is the most serious type of warning used on prescription drug labeling. In May 2007, FDA directed that the warning should be extended to include young adults up through age 24. If an antidepressant is prescribed to a person with bipolar disorder, it can cause mania, and the person can even become psychotic if the mania is severe." http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm095980.htm
FDA Public Health Advisory, June 30, 2005
Suicidality in Adults Being Treated with Antidepressant Medications
"Several recent scientific publications suggest the possibility of an increased risk for suicidal behavior in adults who are being treated with antidepressant medications." http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/DrugSafetyInformationforHeathcareProfessionals/PublicHealthAdvisories/ucm053169.htmFDA Public Health Advisory December 3, 2006
FDA Will Likely Expand Antidepressant Drug Warnings;"The Food and Drug Administration (FDA) will likely expand antidepressant drug warnings after members of a U.S. advisory panel agreed with an FDA analysis that found antidepressant use raises the risk of suicidal thoughts and behavior in teens and young adults up to age 24."
http://psychcentral.com/news/2006/12/13/fda-will-likely-expand-antidepressant-drug-warnings/FDA Public Health Update May 2, 2007 (two weeks after VA Tech murders)
Antidepressant Use in Children, Adolescents, and Adults.
"The U.S. Food and Drug Administration (FDA) today proposed that makers of all antidepressant medications update the existing black box warning on their products' labeling to include warnings about increased risks of suicidal thinking and behavior, known as suicidality, in young adults ages 18 to 24 during initial treatment (generally the first one to two months)." http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm096273.htm
Labeling Change Request Letter for Antidepressant Medications February 25, 2009
"Symptoms of anxiety, agitation, panic attacks, insomnia, irritability, hostility (aggressiveness), impulsivity, akathisia (psychomotor restlessness), hypomania, and mania, have been reported in adult and pediatric patients being treated with antidepressants for major depressive disorder as well as for other indications, both psychiatric and non-psychiatric." http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm096352.htm
FDA Warning Details
Among antidepressants, only Prozac (fluoxetine) is approved for the treatment of pediatric major depressive disorder. Prozac (fluoxetine), Zoloft (sertraline), and Luvox (fluvoxamine) are approved for pediatric obsessive compulsive disorder. None of these drugs are approved as monotherapy for use in treating bipolar depression, either in adults or children.
The requested labeling changes are consistent with recommendations made to the Agency at a meeting of the Psychopharmacological Drugs Advisory Committee (PDAC) and the Pediatric Subcommittee of the Anti-Infective Drugs Advisory Committee (Peds AC), held on February 2, 2004. The possibility of suicidality associated with the use of antidepressant drug products in the pediatric population was also the subject of two previous FDA communications (FDA Talk Paper on June 19, 2003, and FDA Public Health Advisory on October 27, 2003).
FDA is continuing to review available clinical trial data for pediatric patients with depression and other psychiatric disorders to try to determine whether there is evidence that some or all antidepressants increase the risk of suicidality. Later this summer, the FDA plans to update the PDAC and Peds AC about the results of this review.
FDA plans to work closely with each of the nine manufacturers of the antidepressants that are the subject of todayís request to continue investigating how to optimize the safe use of these drugs and implement the proposed labeling changes and other safety communications in a timely manner.