National Assoc School Psychologists Communiqué Re: Paxil, SSRIs

Thu, 18 Dec 2003

In a Communiqué to its membership about regulatory action to protect children from the hazards of Paxil and other antidepressants, The National Association of School Psychologists acknowledges the leading role played by The Alliance for Human Research Protection in publicizing the action taken by UK regulators:

Following the UK ruling on Paxil, the American-based Alliance for Human Research Protection (www.ahrp.org) and other patient advocacy groups asked the FDA to immediately investigate this research in order to determine if the agency should take similar action. Approximately one week later, on June 19, 2003, the FDA took similar action, saying that no one under age eighteen should be prescribed the drug Paxil for major depression because the adult antidepressant may increase a child’s risk of suicide.

FDA’s apparent reluctance to afford independent international experts an opportunity–i.e., reasonable time–to present their analyses of the clinical trial data–including unpublished concealed data–at the forthcoming FDA advisory committee meeting, Feb 2-3, 2004, raises concerns about the integrity of that meeting. Why would FDA officials continue to resist presentations that would provide vital information to the agency and the committee? How can FDA make an evidence-based decision to protect children without the evidence at hand?

October 2003

Drug Regulators Warn Against Using Paxil With Children

By Thomas B. Johnson, NCSP

On June 10, 2003, the UK government’s Medicines and Healthcare Products Regulatory Agency issued a warning that Seroxat (Paxil in the US) must not be used in the treatment of children with depression. The agency took this stand after reviewing data from nine studies based on more than a thousand children. The City Editor of the Daily Mail in England, Alex Brummer, reported that GlaxoSmithKline "may have suppressed a series of negative studies on its key antidepressant drug Seroxat, known as Paxil in the US. In a highly unusual move, a team from the Good Clinical Practice Unit of the Medicines and Healthcare Products Regulatory Agency (MHRA) demanded access to all of GSK’s files and studies on Seroxat" (www.thisislondon.co.uk/news/business/articles/timid63975?version=1). After their review of the studies, the UK agency concluded that "the risk of suicidal thoughts and self harm was two to three times greater among those on Seroxat compared to those on a placebo drug" (www.number-10.gov.uk/output/page3851.asp).

FDA Action

Following the UK ruling on Paxil, the American-based Alliance for Human Research Protection (www.ahrp.org) and other patient advocacy groups asked the FDA to immediately investigate this research in order to determine if the agency should take similar action. Approximately one week later, on June 19, 2003, the FDA took similar action, saying that no one under age eighteen should be prescribed the drug Paxil for major depression because the adult antidepressant may increase a child’s risk of suicide.

They also advised that children and teenagers currently on the medication should not stop the pills suddenly, emphasizing the importance of medical supervision in order to taper off the medication and avoid rebound side effects, such as shock-like sensations and abnormal dreams. The FDA also advised "all makers of adult antidepressants to submit research showing how their drugs affect children. Three studies of Paxil found it didn’t seem to help pediatric depression – but FDA scientists spotted some safety concerns and ordered manufacturer GlaxoSmithKline to reanalyze the data … That reanalysis … found the risk of suicidal thoughts and suicide attempts was three times greater among Paxil users, mostly teens, than among children given dummy pills" www.ctv.ca/servlet/ArticleNews/story/CTVNews/1056372105025_14///). The Vice President of Research and Development and chief medical officer for GlaxoSmithKline, Dr. Anne Phillips, admitted that the adverse effects can include mood fluctuations, increased crying, suicidal thoughts and suicide attempts.

Canada Follows

One of the world’s leading psychiatric/psychopharmacology experts on antidepressants, Dr. David Healy (author of The AntiDepressant Era and The Creation of Psychopharmacology), has warned for years that SSRIs can trigger suicide in some users including children and adults. He also argued that Health Canada should take the same kind of position they are taking on Paxil with the other SSRIs. Canada recently followed the lead of the United States and Britain, informing healthcare professionals and parents that children under eighteen should not take Paxil because it can trigger suicidal thoughts in some users (www.ctv.ca/servlet/ArticleNews/story/CTVNews/10583690841_2///?hub=health).

Additional Warning – From Effexor’s Manufacturer

On August 30, 2003, The Hartford Courant (Altimari and Dolan, see http://www.ctnow.com/news/custom/newsat3/hc-wyeth0830.artaug30,0,5502972.story?coll=hc-headlines-newsat3) reported that the latest warning against prescribing antidepressant drugs for children comes from Wyeth Pharmaceuticals, makers of Effexor, an SSRI similar to Prozac, Zoloft and Paxil. According to the Courant, Wyeth sent a two-page letter (August 22) to healthcare workers in the US warning about the hazards of prescribing Effexor for children. The Wyeth letter states that Effexor was not effective in treating depression or anxiety and was associated with increased “reports of hostility and, especially in Major Depressive Disorder, suicide-related adverse events such as suicidal ideation and self-harm.” Wyeth spokesman Douglas Petkus said the company decided to notify healthcare professionals as a precaution.” Companies typically don’t release data that is sent to the FDA, but in this case we felt it was important for physicians to be aware of the studies because we know it is being prescribed to children,” Petkus said. He also noted that Wyeth is still conducting clinical trials on adolescents.

Thomas B. Johnson, EdD, NCSP, is a licensed psychologist, state and nationally certified school psychologist and Diplomate in Family Psychology (Marital and Family Therapy). He has served as a Contributing Editor for the Communiqué with an emphasis on complementary and alternative perspectives since 1996.