June 10, 2003
FOR IMMEDIATE RELEASE
Baum, Hedlund, Aristei, Guilford & Schiavo
12100 Wilshire Blvd., Suite 950
Los Angeles, CA 90025
Paxil Banned for Children Under 18 in UK due to Increased Risk of Suicide
Los Angeles, June 10, 2003 -- The United Kingdom’s regulatory body, the Committee on Safety of Medicines (the “CSM,” UK equivalent to the FDA) announced today that “[n]ew data from clinical trials in children and adolescents ... do not demonstrate efficacy in depressive illness ... and show an increase in the risk of harmful outcomes including episodes of self-harm and potentially suicidal behavior in the [Paxil] group compared to placebo. Various analyses suggest that the risk of these outcomes is between 1.5 and 3.2 times greater with [Paxil] compared to placebo.” (Emphasis added.) See: http://medicines.mhra.gov.uk/ourwork/monitorsafequalmed/safetymessages/seroxat18.pdf
The announcement also stated with respect to withdrawal:“In studies that used a tapered withdrawal regimen, symptoms reported during the taper phase or upon discontinuation of paroxetine at a frequency of at least 2% of patients and that occurred at a rate at least twice that of placebo were: nervousness, dizziness, nausea, emotional lability (including crying, mood fluctuations, self-harm, suicidal thoughts and attempted suicide) and abdominal pain.” (Emphasis added.)
According to the Chairman of the CSM, Professor G. Duff: “[Paxil] should not be used in children and adolescents under the age of 18 years to treat depressive illness.” (Underline in original.) (Paxil is called “Seroxat” in the U.K.)
This is the result of a review conducted by an independent panel appointed by the UK Regulators to look into Paxil and other SSRIs (such as Zoloft and Prozac) and their relationship to suicide and withdrawal. The first group impaneled was disbanded after revelations that some of the members had shareholdings in GSK and other SSRI-producing companies. The group was recently re-formed. According to yesterday’s Daily Mail in London, GSK may have “suppressed a series of negative studies,” but, today GSK denied claims that it was involved in a cover-up. See: http://www.guardian.co.uk/uk_news/story/0,3604,974175,00.html
Karen Barth, an attorney representing thousands of victims (including children) of SSRIs such as Paxil and Zoloft, stated in response to the announcement: “We have been litigating this issue (that these drugs can cause suicide and self harm in some people, including children) on behalf of victims of Paxil and other SSRIs for more than a decade. The manufacturers of the SSRIs, including GSK, have continuously and adamantly denied even the possibility of a causal connection and instead have blamed the victim and the ‘disease.’ While we believe this will bring some vindication to those who have had the courage to fight a formidable industry, in truth, this is a tragic illustration of corporate greed and influence. How many children have died or been placed at serious risk as a result of the SSRIs (Paxil, Zoloft, Prozac)?
In fact, the evidence we have uncovered demonstrates that this is no surprise to these companies. The question now is, what is the FDA going to do about it? Is it going to continue to stand by and bow to the pressures of industry or will it provide similar protection to America’s youth?”
According to reports from the UK, there are an estimated 8,000 children under the age of 18 taking Paxil in the UK. Meanwhile, 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."
June 2003 letter from GlaxoSmithKline to Healthcare Professionals in the UK - "Re: Seroxat (paroxetine hydrochloride) - contraindication in children under 18 for the treatment of major depressive disorder"
If you are concerned, we encourage you to communicate your views to the FDA and Congress:To contact your representatives in congress, go to: http://www.visi.com/juan/congress/
You only need to put in your address and press enter and you will receive a list of your representatives’ telephone numbers, facsimile numbers, as well as website and email addresses. You should contact each one of your representatives to express your concern. The sooner, the better, since this has just occurred. You may call, email or send a fax.
To register a complaint with the FDA, go to: http://www.fda.gov/opacom/backgrounders/complain.html
