Seroquel was voted to be “acceptably safe” and effective for the treatment of schizophrenia in teenagers, said a U.S. Food and Drug Administration (FDA) panel of outside medical experts that reviews such indications for the FDA.
The FDA is not required to follow the advice of such expert panels it employs, but usually does.
Seroquel (Quetiapine Fumarate), a newer atypical antipsychotic psychiatric medication, is currently approved to treat schizophrenia and bipolar disorder in adults. The company who makes Seroquel, AstraZeneca, is seeking FDA approval to market the drug to treat schizophrenia in adolescents ages 13 to 17 and bipolar disorder in children ages 10 to 17.
Thomas Laughren, director of the FDA’s psychiatric product division, admitted there are significant risks associated with drugs such as Seroquel, but that children and teens have limited psychiatric treatment options available for bipolar disorder and schizophrenia.
Doctors may already prescribe Seroquel, and drugs like it, to children and teens for disorders such as schizophrenia and bipolar disorder in what is called “off-label use.” However, pharmaceutical companies are not allowed to market such use to professionals or consumers unless they go through an additional FDA approval process. If the FDA approves Seroquel’s use for teenagers in the treatment of schizophrenia, it would allow AstraZeneca to begin marketing such use to doctors and consumers.
U.S. Food and Drug Administration said on Friday that Seroquel and two other drugs — Geodon and Zyprexa — were effective at treating certain psychiatric disorders (such as schizophrenia or bipolar disorder) in children and adolescents.
But the FDA acknowledged too that they carry “significant risks” that included sedation and weight gain, the latter being of particular concern as it can significantly increase the risk of diabetes and heart disease.
Increased blood pressure and appetite are the two most frequently occurring side effects that were observed more often in children and teens than adults who were taking Seroquel.
Schizophrenia is a debilitating mental disorder characterized by the presence of hallucinations or delusions in people afflicted. It is typically not commonly diagnosed in children and is usually first diagnosed in later teenage years or early adulthood (between ages 20 and 29).
Seroquel is AstraZeneca’s second-best selling drug with $4.45 billion in sales in 2008.