Evelyn Pringle April 13, 2009
Last week, an FDA Advisory Committee voted against the approval of the atypical antipsychotic, Seroquel, to treat General Anxiety Disorder and Major Depressive Disorder in adults because the benefits of the drug for those indications did not outweigh the risks.
"Extension of labeling to these common indications would likely result in the exposure of hundreds of thousands if not millions of patients to substantial medical risks without significant clinical benefit to justify these risks," Harrisburg Pennsylvania psychiatrist, Stefan Kruszewski, told committee members in a submission to the panel.
The drug was initially approved only to treat schizophrenia and later for manic-depression, now called bipolar disorder.
According to the National Institute of Health, bipolar disorder affects about 5.7 million adults age 18 or older in a given year in the US and the median age of onset is 25. Approximately 2.4 million adults over the age of 18 have schizophrenia in any given year. Schizophrenia often appears in men in their late teens or early twenties but women are generally affected in their late twenties or early thirties, the NIH reports.
The briefing material submitted to the advisory panel reported that an estimated 25.9 million patients worldwide have been exposed to Seroquel since its launch in 1997, through July 31, 2007 in the US, and the second quarter of 2007 for countries outside the US. Of that number, an estimated nearly 15.9 million people took Seroquel in the US, compared to only 10 million in the rest of the world.
As of July 2009, the World Factbook estimated the world population to be 6,790,062,216 and the US population to be a mere 307,212,123. Yet in 2008, the US accounted for $3.015 billion of the $4.452 billion of Seroquel's worldwide sales. It was AstraZeneca's second-best selling drug behind the heartburn drug Nexium. Seroquel was the fifth top drug in sales overall in the US in 2008.
In terms of overall prescription sales in the US, antipsychotics led all therapy classes in 2008, ahead of even cholesterol medications, according to IMS Health.
The new class of antipsychotics comes with a host of serious adverse effects. One section of the briefing documents submitted to the FDA advisory committee states:
"Atypical antipsychotics have been associated with several safety issues. Among the major safety issues are increased mortality in elderly patients with dementia-related psychosis, suicidality in children and adolescents, clinical worsening and suicidality, neuroleptic malignant syndrome, tardive dyskinesia (TD), orthostatic hypotension, hyperglycemia and diabetes mellitus."
As for the most worrisome, often non-reversible and disfiguring movement disorder, tardive dyskinesia, an FDA reviewer pointed out: "Although we have asked the sponsor in the 2005 meeting that the benefit/risk assessment must include tardive dyskinesia for this patient population, no additional assessment by the sponsor was identified in this submission."
Big Pharma watchdog, Vince Boehm, reports that AstraZeneca is now asking the FDA to approve Seroquel to treat kids 13 and older with schizophrenia and bipolar disorder in children aged 11 and up. For the last advisory meeting, one reviewer wrote:
"The Written Request from FDA to the sponsor, dated 11 February 2003, specifically asked that AstraZeneca conduct randomized, double-blind, parallel-group, placebo-controlled efficacy and safety studies in pediatric patients who have schizophrenia, mania in the setting of bipolar disorder. In addition, the Written Request stipulated that pharmacokinetic data in the relevant pediatric age group would also be required."
More than 5 years later, on April 3, 2008, Astra submitted an "overview of their plans of the phase IV pediatric obligations," the reviewer notes.
Seroquel is already prescribed off-label to kids, some less than a year old, for everything from ADHD to sleep problems. The motive behind the attempt to drug more legally is easy to figure out. The price of Seroquel at DrugStore.com is $839 for 100 200mg tablets.