On June 11, 2009, FDA News reported that AstraZeneca's Seroquel, Pfizer's Geodon and Eli Lilly's Zyprexa atypical antipsychotics "won an FDA advisory panel's recommendations for approval to treat schizophrenia and bipolar disorder in pediatric and adolescent patients."
"The FDA's expanded marketing approval process for antipsychotics, highly toxic drugs, is unaffected by evidence uncovered by the US Justice Department showing that the studies submitted by drug manufacturers were often flawed, if not fraudulent," says Vera Hassner Sharav, president of the Alliance for Human Research Protection, in a June 8, 2009 infomail alert.
"Rather than focus on protecting children's safety, FDA officials are doing their utmost to legitimize irresponsible, off-label prescribing of exceedingly toxic antipsychotics for children—thereby ensuring that far greater numbers of children will be victimized and die," according to Sharav.
A recent report by the consulting firm Decision Resources found antipsychotics makers spent $993,000,000 in 2006, to promote these drugs to doctors and patients, she reports. In 2008, at more than $14 billion, antipsychotic revenues topped all other classes of drugs in the US, even cholesterol and diabetes medications.
On November 17, 2008, on the popular Furious Seasons website, Philip Dawdy reported that Zyprexa had killed 3,455 people between 1997 and early 2008, based on a review of an FDA staff document with a summary of adverse events in the agency's database.
From 1993 through the first three months of 2008, 1,207 children on Risperdal suffered serious adverse events, including 31 who died, according to a report in the November 18, 2008 New York Times.
The deaths included a 9-year-old child, receiving Risperdal for the unapproved use of ADHD, who suffered a stroke twelve days after starting the drug. At least eleven of the deaths were in children whose treatment was for an unapproved use.
In May 2009, CBS News reported that Risperdal was causing boys to grow breasts due to increased prolactin levels caused by the drug. The news segment featured a boy who was prescribed Risperdal for ADHD, and had to undergo a double mastectomy to remove the breasts.
Philadelphia attorney, Steve Sheller, represents six boys who developed breasts after taking Risperdal, in lawsuits against Johnson & Johnson. Two have had mastectomies.
On June 3, 2009, Medscape reported that findings presented at the American Psychiatric Association annual Meeting, on the preliminary results from the "Metabolic Effects of Antipsychotics in Children" study, "show that 12 weeks of initial antipsychotic treatment was associated with significant mean increases in overall adiposity and percentage of body fat, as well as a decrease in whole-body insulin sensitivity."
"Further," Medscape said, "the investigators found antipsychotic treatment was also linked to significant increases in body-mass index (BMI) percentile and fasting plasma triglyceride levels, both clinically available indicators of adverse metabolic changes associated with increased adiposity."
In terms of live-long health issues: "This is a serious problem," says Dr Steven Nissen, chairman of the Department of Cardiovascular Medicine at the Cleveland Clinic, and past president of the American College of Cardiology.
"The substantial increase in body fat and increased insulin resistance will almost certainly lead to a higher lifelong incidence of diabetes," he warns.
"Diabetes is a major cause of heart attack, stroke, kidney failure, blindness, and limb amputation," Dr Nissen points out.
In an April 2008, editorial, in Psychotherapy and Psychosomatics, titled, "Irrational Healers," Dr David Healy, author of the new book Mania: A Short History of Bipolar Disorder writes:
For fifty years, the antipsychotics were viewed as too dangerous to use outside secondary care and were largely restricted to those with chronic psychotic disorders where the trade-off between hazards and benefits justified treatment.
Yet now a new generation of possibly even more problematic antipsychotics is being given to preschoolers, in North America, on the basis that they might have a disorder that most of the rest of the world does not believe happens in children.
"FDA officials are ignoring the real world tragedies—drug-induced deaths of children," Sharav warns.
