Risks of Antidepressant Drugs

FACT SHEET

A Sampling of Important
Data and Events

Antidepressant Forum speaker, Karen Barth Menzies, is the lead attorney for Witczak v. Pfizer. Lawyer's Weekly USA named Barth Menzies one of their Top Ten Lawyers of 2004, and she was chosen by The National Law Journal for their "40 Under 40," acknowledging her work on antidepressant safety issues.

Barth Menzies is a partner of Baum Hedlund, a national pharmaceutical products liability law firm. The firm has represented many clients in SSRI-related homicide and suicide cases, including the widow of 1960s rock star Del Shannon and the family of comedian Phil Hartman.

December 7, 2005 - The final pre-trial hearing in Kimberly Witczak's Zoloft-suicide lawsuit will be held in Minneapolis. This is the first suicide-related suit against Zoloft maker, Pfizer, to go to trial. Mrs. Witczak asserts that Zoloft induced her husband, Timothy ("Woody") Witczak, to commit suicide after suffering severe adverse reactions to the drug. Mr. Witczak was prescribed Zoloft for difficulty sleeping due to job-related stress. He was on Zoloft for about five weeks with an increase in his dose before he committed suicide. He had no history of mental illness or suicidality nor does there appear to be any history in his family.

His symptoms after Zoloft and before his death included profuse sweating, worsened insomnia, horrible nightmares, headaches, agitation and an odd feeling in his head (he told his wife that he felt like his head was "detached from [his] body.") This phenomenon is known as akathisia and has been acknowledged by Pfizer in internal company documents to be a side effect of Zoloft.

Kim Witczak has traveled to Washington D.C. on numerous occasions to lobby Congress to increase FDA scrutiny and raise awareness of the risks of Zoloft and other drugs in its class. She testified at the FDA advisory committee meeting which resulted in the FDA's request for black box warnings concerning the increased risk of suicidality in children and adolescents. On July 20, 2005 the Minnesota State Attorney General rejected Pfizer's effort to dismiss the Timothy ("Woody") Witczak suicide trial.
Link to Story

This is not an isolated incident (as Barth-Menzies will explain). The most notorious suicide associated with these drugs is that of nineteen-year-old Bible student, Traci Johnson, who had no prior depressive symptoms. Yet Traci committed suicide February 7, 2004 at Eli Lilly's headquarters while participating in a study of Lilly's new antidepressant duloxetine to earn money for college. (Duloxetine is now being marketed as Cymbalta.)
Link to Story

Side Effects and Withdrawal Symptoms*
Selective serotonin reuptake inhibitors for children and adolescents with major depression: current controversies and recommendations
Link to Summary (Abstract)

Up to 86% of patients experience at least one of the side effects of SSRI/SNRI antidepressants. The FDA has long warned about multiple side effects of these drugs; for example, the agency states that Prozac may cause bleeding or breathing problems, nausea, difficulty sleeping, anxiety, sexual problems, rash, mania, or seizures.
Link to a FDA Alert
Link to a Sexual Side Effects Summary (Abstract)

Fifty to 85% of those attempting to discontinue SSRI antidepressants report such withdrawal symptoms as dizziness, confusion, flu-like symptoms, GI problems, anxiety, depression, sleep problems and neurological symptoms such as tingling or electric shock sensations.
Link to Summary (Abstract)
*For additional references on these topics, see Prozac Backlash (Simon and Schuster, 2000) by Joseph Glemmullen, MD

U.S. Government Warnings
September 27, 2005 - The FDA, in conjunction with GlaxoSmithKline (GSK), announced the results of their joint retrospective epidemiologic study showing an increase in the risk of overall major congenital malformations (birth defects) for paroxetine (Paxil) as compared to other antidepressants.
Link to FDA warning and the GSK Letter to Healthcare Professionals

July 1, 2005 - The FDA issued a Public Health Advisory instructing health care providers and adult patients to watch closely for worsening of depression and for increased suicidal thinking or behavior in adults.
Link to FDA Talk Paper

October 15th 2004 - FDA announced it would require "Black Box" warnings (reserved for drugs with the most dangerous risks). Found to have an increased risk of suicide in children and adolescents, the drugs targeted are: Prozac, Paxil, Zoloft, Wellbutrin, Effexor, Celexa, Lexapro, Serzone, Luvox and, Remeron.
Link to FDA Public Health Advisory

National Developments
September 2, 2005 - Psychiatric News reports a 20 percent drop in U.S. prescriptions of antidepressant drugs for youth since the FDA issued its public health advisory on March 22, 2004, warning that the drugs were associated with an increased risk of suicidality in both children and adults. A similar report had show a 23% decline over the first two quarters of 2004.
Link to Article
Link to Article

January 5, 2005 - USA Today and CNN report the exposure of suppressed internal documents showing that Eli Lilly knew in the mid-80's that Prozac takers had far higher rates of suicide attempts, aggression and self-injury than those taking any of the other four antidepressants on the market at the time. For example, one Lilly document showed Prozac patients were more than 4 times as likely to attempt suicide compared to patients given an older tricyclic.
Link to Article
Link to Suppressed Documents

December, 9, 2004 - ABC News aired newly uncovered documents showing that GlaxoSmithKline, maker of Paxil, failed to disclose data that shows an increased risk of suicide and a dramatic increase in the risk of addiction related to the use of Paxil.
Link to Article

March 15, 2004 - Due to evidence linking Serzone to liver damage, a suit against the FDA was filed by Public Citizen for failure to ban Serzone in the US, citing 20 deaths directly attributable to that drug. Bristol-Meyers Squibb pulled Serzone from the U.S. market three months later. (Canada had banned the drug in November, 2003, and it had previously been banned in Europe).
Link to Article
Link to Article

International Developments
February 18, 2005 - A new UK study finds that adult patients taking SSRI/SNRI antidepressants may be twice as likely to attempt suicide than if they were not taking any drugs at all.
Link to Article

December 6, 2004 - The British government, which has been taking the lead in restricting antidepressant use, announced that antidepressants "should not be used at all" as the first line of defense against mild depression, even for adults, because "the risk-benefit ratio is poor." Effexor was singled out as particularly hazardous and banned for anyone with heart disease.

December 10, 2003 - The British government banned the use of all SSRI antidepressant drugs (except Prozac) for children and teens. The banned drugs were Paxil, Effexor, Zoloft, Celexa and Lexapro. Prozac was subsequently added to the ban in April, 2005 by the European Medicines Agency.

For extensive links to events, warnings, studies, and news reports, go to either
www.woodymatters.com (dedicated to the memory of Woody Witczak)
or
AntidepressantFacts.com

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