March
22, 2004
FOR IMMEDIATE RELEASE
Los Angeles, California, March 22, 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 Hedlund’s 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-to-Tierney-Letter/A.pdf),
the FDA would have continued tolerating this unwarranted danger.
“Through our litigation over the past 13 years, we’ve 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-to-Tierney-Letter/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.”
(See updated statements in response to FDA and media reports regarding the FDA's warnings request. )
For more background information and a chronology of events leading up to today’s announcement, please see:
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
Biting the Magic Bullet: A Look at the SSRI Litigation
