June 19, 2003


Baum, Hedlund, Aristei, Guilford & Schiavo
12100 Wilshire Blvd., Suite 950
Los Angeles, CA 90025
Contact: Robin McCall, Media Relations
Day: (800) 827-0087 or (310) 207-3233

Paxil Victims React to FDA's Announcement re Suicide Risk in Children

Attorneys Representing Thousands of Paxil Victims Respond

LOS ANGELES--June 19, 2003--"Finally, after faced with public pressure from the recent action by U.K regulators, the FDA has agreed to review reports of increased risk of suicide caused by Paxil," stated attorney Karen Barth, of the national law firm Baum, Hedlund, Aristei, Guilford & Schiavo. She is responding to today's statement by the Food and Drug Administration (FDA) recommending that the antidepressant Paxil not be used in children or adolescents for the treatment of depression.
Link to FDA's Advisory: http://www.fda.gov/bbs/topics/ANSWERS/2003/ANS01230.htmland Q&A

The data revealed that Paxil can triple the risk of suicidal behavior in minors. "Of course, because Paxil can cause serious withdrawal symptoms, including severe dizziness, nausea, 'electric zap' sensations, and 'emotional lability' (defined by Paxil maker GlaxoSmithKline (GSK) as 'crying, mood fluctuations, self-harm, suicidal thoughts and attempted suicide'), the FDA has put an advisory in all capital letters and in a box at the top of its statement that it is 'essential' that Paxil not be stopped suddenly. (It took the FDA a decade before it forced GSK to change its warning about Paxil withdrawal.) In other words, kids are damned if they do and damned if they don't," stated Attorney Barth.


The Los Angeles-based law firm of Baum, Hedlund, Aristei, Guilford & Schiavo represents victims of both the suicide side effects caused by the SSRIs (the class of antidepressant drugs known as the selective serotonin reuptake inhibitors, Paxil, Zoloft and Prozac) and the withdrawal side effects caused by Paxil and Zoloft. Baum Hedlund represents thousands of Paxil victims and has been litigating failure-to-warn cases against the drug companies who manufacture these antidepressants for 12 years.


Attorney Karen Barth added: "I hope I am wrong in my skepticism about the FDA and that it does not white-wash the suicide risk as it has done in the past. But the FDA's recent actions cause me concern. The FDA this past year joined forces with Pfizer, the manufacturer of Zoloft, by submitting an amicus ('friend of the court') brief in one of our Zoloft suicide cases, stating that it would not allow Pfizer to place a suicide warning in the label for Zoloft even if Pfizer sought to include one because, to do so, according to FDA attorneys, would misbrand the drug."


Baum Hedlund later learned that the FDA's intervention in the case was the result of a telephone call between the FDA's newly appointed Chief Counsel, Daniel Troy, and Pfizer's national counsel. Alarmingly, Baum Hedlund also learned that Mr. Troy worked for Pfizer during the pendency of the case.

"The FDA is violating its own mandate to act in the interests of the American consuming public by taking sides with the pharmaceutical companies it is supposed to police," Barth stated.


After hearing the news of the FDA's intervention in these cases, numerous law professors and attorneys have contacted the Baum Hedlund firm about the impropriety of the FDA's involvement in private litigation in favor of drug companies. The current regulatory administration, including not only Daniel Troy, but also Alexander Azar, the General Counsel of the Department of Health & Human Services, has not been phased; but instead, has continued its public campaign by giving speeches at industry seminars and recruiting pharmaceutical defense attorneys to support its position.

The FDA also intervened to prevent a United States District Court judge in California from forcing Paxil's manufacturer, GlaxoSmithKline, to stop airing television commercials that proclaimed Paxil to be "non-habit forming."

Link: http://www.baumhedlundlaw.com/media/ssri/paxil/Injunction/pr_inj3.htm


Barth further stated: "The FDA is already sanitizing its action with numerous statements that Paxil is okay for adults, whereas the U.K. regulators said they will 'examine urgently' these data with regard to the use of SSRIs in adults. I fear the FDA, under its current administration, lacks the ability to do a truly objective analysis. In one of our suicide cases, the FDA's position is based upon inconclusive and biased reviews done over ten years ago. Does that mean on a child's 18th birthday this risk suddenly disappears? For example, one of our client's children killed himself at age 19. Perhaps we need to remind the FDA of the 8 million dollar verdict a Wyoming jury awarded in 2000 against GSK in a case where a man taking Paxil killed his wife, his daughter, his granddaughter and then committed suicide.


"The manufacturers of the SSRIs, including GSK, have continuously and adamantly denied even the possibility of a causal connection between the SSRIs and suicide, and, instead, have blamed the victim and the 'disease.' This is notwithstanding clear evidence very early on in the clinical trials of these drugs that they can cause these problems. We have documents obtained through discovery in our litigation showing that there was an awareness of the problem as far back as the late 1970s, long before the first SSRI (Prozac) was approved for marketing in this country. In fact, the German equivalent to the FDA (the 'BGA') initially refused to license Prozac for distribution in that country due to the disproportionate number of suicides in the clinical trials. Germany eventually allowed the drug on the market, however, only with a stronger suicide warning. The reality is that all of the SSRIs, Paxil, Zoloft and Prozac, share the same side effect profile regarding suicide and the safety of these drugs needs to be re-examined, objectively."

According to a study released on June 1, 2003, in the Journal of the American Academy of Child and Adolescent Psychiatry: "SSRIs have become the most rapidly increasing psychotropic used to treat children and adolescents in the United States."


Link to background information and UK ban: http://www.baumhedlundlaw.com/media/ssri/paxil/UKchildren.htm


Baum Hedlund has been litigating SSRI cases around the country for over a decade. They were 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. The firm has represented families of suicide victims, including the widow of 1960s rock star, Del Shannon, and the family of comedian Phil Hartman and his wife, Brynn. The firm represents clients in suicide and injury cases against the makers of Paxil and Zoloft. Baum Hedlund attorney Karen Barth was on the trial team in one of the only SSRI suicide cases to go to trial. Additionally, Baum Hedlund filed the first Paxil class action lawsuit related to withdrawal.