FDA Panel Supports the Use of Seroquel for Children but Consumers should Tread Cautiously
Tuesday, June 16th, 2009On June 10, 2009, a Food and Drug Administration (FDA) panel supported the use of Seroquel, a mood-stabilizing medicine manufactured by AstraZeneca, in children and adolescent, stating that the drug was “acceptably safe” and useful to treat schizophrenia and bipolar disorder. At this time, FDA has not officially approved Seroquel for use in children and adolescents.
Seroquel is an oral medication used to control the symptoms associated with schizophrenia. Seroquel is AstraZeneca’s second-best-selling drug with $4.45 billion in sales in 2008. AstraZeneca is asking FDA to approve to market Seroquel in patients aged 13 to 17 with schizophrenia, and in patients aged 10 to 17 with bipolar disorder.
Schizophrenia afflicts about 1% or around 2.4 million Americans, specifically those in their late teens and early 20’s. Bipolar disorder is significantly more severe when found in children than adults and is characterized by frequent mood shifts and energy levels. It affects anywhere from 1-3 percent or around 5.7 million Americans.
In 1997, the FDA approved Seroquel for the treatment of schizophrenia. However, the FDA has also reported that Seroquel has serious side effects when used by adult or elderly patients, including:
- An increased chance of death in elderly person
- Neuroleptic malignant syndrome (NMS), a life-threatening nervous system problem that can cause high fever, muscle stiffness, sweating, a fast or irregular heartbeat, a change in blood pressure and confusion
- An uncontrollable muscle movement condition known as tardive dyskinesia
- High blood sugar and diabetes
Seroquel lawsuits allege that AstraZeneca knew of Seroquel’s side effects, but did not take adequate steps to warn doctors and patients of them. In addition, the lawsuits also allege that AstraZeneca aggressively marketed and promoted Seroquel for “off label” use, despite not getting FDA approval during that time.
The FDA panel also supports use of another drug Zyprexa, manufactured by Eli Lilly & Co., for use as a second-line treatment, or a second option after other drugs have failed in adolescents, because of concerns about significant weight gain in many adolescent patients. In schizophrenia studies of Lilly’s Zyprexa, more than 30 percent of adolescents gained weight, compared with just 6 percent of adults. On average, adolescents gained nearly 10 pounds, compared with 6 pounds for adults. Zyprexa is Lilly’s top-selling drug with $4.7 billion in sales in 2008. Lilly is seeking FDA’s approval for Zyprexa in patients aged 13 to 17 with schizophrenia, and in patients aged 10 to 17 with bipolar disorder.