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Statement regarding FDA antidepressant advisory for adults and suicidality

July 1, 2005
FOR IMMEDIATE RELEASE

Statement regarding FDA antidepressant advisory for adults and suicidality

Los Angeles, California, July 1, 2005 - - We are hopeful that physicians will heed these warnings now that the FDA has finally acknowledged that suicide can be a deadly side effect for adults, not just children, taking SSRI antidepressants. This suicide and violence side effect can happen to anyone who takes these drugs regardless of the reason for the prescription.

For fifteen years the pharmaceutical companies have been blaming the patients and the "disease" for the violence and suicides. Doctors and family members must be aware that the drug itself can make the patient become violent and suicidal.

This FDA action is encouraging. Perhaps the exposure of FDA failures over the last few years has forced the FDA to become less complacent and initiate action on safety risks. The tireless efforts of victims and consumer advocates, coupled with the courage of scientists and FDA whistle-blowers have helped to expose this very serious risk. This has been accomplished despite pharmaceutical companies' awareness and subsequent cover-up of the risk since the mid-1980s, as shown by the evidence we have acquired.

While FDA should have taken this action back in 1991 when first presented the evidence of a suicide risk, we appreciate that the FDA has issued this advisory now instead of waiting. Now, if physicians and physicians' organizations pay attention to this information, lives will be saved.

- Karen Barth Menzies


  • Possible Link Between Antidepressants and Suicide in Adults Under FDA Review - FDA Talk Paper http://www.fda.gov/bbs/topics/ANSWERS/2005/ANS01362.html
  • FDA's Public Health Advisory - Suicidality in Adults Being Treated with Antidepressant Medications http://www.fda.gov/cder/drug/advisory/SSRI200507.htm

Baum Hedlund partner, Karen Barth Menzies, heads the firm's SSRI Litigation Department and is Lead Counsel and a member of the Plaintiffs' Steering Committee in charge of MDL-1574 in re Paxil Products Liability Litigation.

Since 1990 Baum Hedlund has been involved in SSRI (selective serotonin reuptake inhibitors)-induced suicide/violence litigation and served on the Plaintiffs' Steering Committee in the first SSRI-suicide litigation involving Prozac (the first SSRI approved by the FDA for marketing in the U.S.). The firm maintains a leadership role in antidepressant litigation and currently represents thousands of Paxil withdrawal victims and dozens of suicide and/or suicide attempt cases involving Paxil or Zoloft across the country.

Ms. Barth Menzies twice testified before the FDA Advisory Committee in 2004 regarding the risk of suicide in children and adolescents taking antidepressants. The evidence presented by Ms. Barth Menzies and other individuals at the first hearing resulted in the advisory panel urging the FDA to issue warnings immediately. Following her testimony, as well as the testimony of dozens of victims and consumer advocates in the follow-up hearing in Sept. 2004, the committee recommended that antidepressants include a "black box" warning, the FDA's most severe warning, that antidepressants not only cause some minors to become suicidal, but have also failed to demonstrate that they relieve depression. She also testified at a hearing before the California State Senate in 2004 regarding antidepressant drugs and suicide.

In the past year Karen Barth Menzies was named one of California Lawyer magazine's California Lawyers of the Year for her work on antidepressant safety issues. She was among 10 lawyers in the nation named Lawyer of the Year by Lawyer's Weekly USA for her "Crusade for Suicide Warnings on Antidepressants." Just recently, she was among 40 top attorneys chosen by The National Law Journal to be included in their "40 Under 40" list for her "extraordinary achievements" and "impressive track record" for "stepping up her fight in the past few years, advocating that pharmaceutical companies should warn about the alleged risks of antidepressant drugs."

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