FDA finally concedes antidepressant suicide risk after 13-year fight for warning
We are pleased the FDA is finally requiring the manufacturers of these drugs to include warnings about the suicide risk, however, it should not have taken over a decade to do so. Victims, experts and consumer advocates have been fighting for these warnings for many years."
Los Angeles, CA (PRWEB) March 25, 2004 -- Today, the FDA asked manufacturers of several antidepressants (Zoloft, Paxil, Prozac, Effexor, Luvox, Celexa, Lexapro, Wellbutrin, Serzone, and Remeron) to include in their Warning Labels that patients (both adults and children) should be closely monitored for the emergence of suicidality. See:
http://www.fda.gov/cder/drug/antidepressants/AntidepressanstPHA.htm
Baum Hedlund attorney, Karen Barth Menzies, (who testified at the February 2, 2004 FDA hearing regarding antidepressants and suicide in the pediatric population) http://baumhedlundlaw.com/media/ssri/paxil/FDAHearing/FDA.htm stated: We are pleased the FDA is finally requiring the manufacturers of these drugs to include warnings about the suicide risk, however, it should not have taken over a decade to do so. Victims, experts and consumer advocates have been fighting for these warnings for many years. Instead of requiring a warning, the FDA has steadfastly sided with antidepressant manufacturers and, in fact, recently went so far as to intervene in private litigation involving one of Baum Hedlunds clients in favor of drug manufacturers arguing that any suicide warning would be illegal! The truth is, absent pressure from lawsuits, the public and, we believe, an FDA insider
(http://baumhedlundlaw.com/media/ssri/paxil/FDAHearing/Links%20to%20Tierney%20Letter/A.pdf), the FDA would have continued tolerating this unwarranted danger.
Through our litigation over the past 13 years, weve seen the internal documentation that shows the drug companies have known that their drugs can cause suicide and violence even before the drugs were approved for marketing. Moreover, both the FDA and drug companies have known that these drugs are only marginally effective in treating depression, thus the perception that the benefits outweigh the risks is based on misleading promotion of the drugs benefits. http://baumhedlundlaw.com/media/ssri/paxil/FDAHearing/Links%20to%20Tierney%20Letter/G.pdf.
We are especially pleased to see that the FDA is including adults in the Warnings. During the recent review of data related to pediatric use, the drug companies have attempted to distinguish between adults and children, claiming that the suicide and violence risks do not apply to adults. The evidence we have seen shows there is no such distinction.
It should be emphasized that, for the first time the FDA has acknowledged that the suicidal risk ‘might be a result of drug therapy, rather than blaming the ‘underlying disease. This should alert doctors that the reactions their patients are experiencing such as suicidality, agitation, akathisia, and hostility may be due to the drug. Increasing doctors awareness of these reactions will save lives."
For more background information and a chronology of events leading up to todays announcement, please see: http://baumhedlundlaw.com/media/ssri/paxil/BH-UKban.htm
http://baumhedlundlaw.com/media/ssri/paxil/FDAHearing/FDA.htm
http://baumhedlundlaw.com/media/ssri/paxil/FDAHearing/FDA-Tierney.htm
Published articles by Karen Barth Menzies:
The Fox in the Chicken Coop FDA's Recent Intervention in Pharmaceutical Litigation
http://www.baumhedlundlaw.com/AttorneyArticles/kb-ssrilitigation/FDA-Intervention.pdf
Biting the Magic Bullet: A Look at the SSRI Litigation
http://www.baumhedlundlaw.com/AttorneyArticles/kb-ssrilitigation/SSRI-litigation.pdf
Karen Barth Menzies is spearheading the Paxil withdrawal litigation in the United States. Ms. Barth Menzies, a partner in the national law firm of Baum Hedlund since 1996, represents approximately five thousand victims of Paxil and Zoloft. Her firm, filed the first class action against the makers of Paxil, Glaxo SmithKline, in 2001 and has subsequently filed class actions, mass joinders and individual death cases across the United States. Ms. Barth Menzies also represents the families of victims (including children) who have committed suicide while under the influence of Paxil. She also represents suicide victims of the SSRI, Zoloft. Baum Hedlund has been actively involved in SSRI litigation since 1990 including having represented the widow of 1960s rock star, Del Shannon, and the family of comedian Phil Hartman and his wife, Brynn. The firm was 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.) in the early 1990s. Ms. Barth Menizes was on the trial team in one of the only SSRI cases to go to trial, a homicide/suicide case, in 1999.
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