Violence

Prozac (fluoxetine)
Zoloft (sertraline)
Paxil (paroxetine)
Luvox (fluvoxamine)
Celexa (citalopram)
Lexapro (escitalopram)
Wellbutrin (bupropion)
Effexor (venlafaxine)
Serzone (nefazodone)
Remeron (mirtazapine)

More Than 1900 Violent Events Worldwide Since 1988 Believed Related to Antidepressants. http://www.ssristories.com/index.php.

Repeated FDA Warnings

FDA Public Health Advisory, March 22, 2004
Worsening Depression and Suicidality in Patients Being Treated With Antidepressants
http://www.fda.gov/cder/drug/antidepressants/AntidepressanstPHA.htm

FDA Public Health Advisory, June, 2005
http://www.fda.gov/cder/drug/advisory/SSRI200507.htm)

FDA Public Health Advisory Dec. 13, 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/cder/drug/antidepressants/default.htm

FDA Warning Details

Health care providers should carefully monitor patients receiving antidepressants for possible worsening of depression or suicidality, especially at the beginning of therapy or when the dose either increases or decreases. Although FDA has not concluded that these drugs cause worsening depression or suicidality, health care providers should be aware that worsening of symptoms could be due to the underlying disease or might be a result of drug therapy.

Heath care providers should carefully evaluate patients in whom depression persistently worsens, or emergent suicidality is severe, abrupt in onset, or was not part of the presenting symptoms, to determine what intervention, including discontinuing or modifying the current drug therapy, is indicated.

Anxiety, agitation, panic attacks, insomnia, irritability, hostility, impulsivity, akathisia (severe 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 nonpsychiatric. Although FDA has not concluded that these symptoms are a precursor to either worsening of depression or the emergence of suicidal impulses, there is concern that patients who experience one or more of these symptoms may be at increased risk for worsening depression or suicidality. Therefore, therapy should be evaluated, and medications may need to be discontinued, when symptoms are severe, abrupt in onset, or were not part of the patient’s presenting symptoms.

If a decision is made to discontinue treatment, certain of these medications should be tapered rather than stopped abruptly (see labeling for individual drug products for details).

Because antidepressants are believed to have the potential for inducing manic episodes in patients with bipolar disorder, there is a concern about using antidepressants alone in this population. Therefore, patients should be adequately screened to determine if they are at risk for bipolar disorder before initiating antidepressant treatment so that they can be appropriately monitored during treatment. Such screening should include a detailed psychiatric history, including a family history of suicide, bipolar disorder, and depression.

Health care providers should instruct patients, their families and their caregivers to be alert for the emergence of agitation, irritability, and the other symptoms described above, as well as the emergence of suicidality and worsening depression, and to report such symptoms immediately to their health care provider.

Background

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 is 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 today’s 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.

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