FDA Panel Recommends Approval of Seroquel, Geodon and Zyprexa for Children, TeensThree atypical antipsychotics — Seroqiel, Geodon, and Zyprexa — were voted to be “acceptably safe” and effective for the treatment of schizophrenia and bipolar disorder in teenagers and children, 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. The drugs were recommended for approval in use in children as young as 10 years old.

The three drugs, considered newer atypical antipsychotic psychiatric medications, are currently approved to treat schizophrenia and bipolar disorder in adults. The combined sales of the three drugs in the U.S. is $10 billion.

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 often already prescribe these drugs 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 these drugs’ use for the treatment of schizophrenia and bipolar disorder in children and teens, it would allow the drug makers to begin marketing such use to doctors and consumers.

The FDA has acknowledged that these kinds of drugs can 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).

Bipolar disorder is a serious mental disorder characterized by mood swings between extreme energy and depression and is also not typically diagnosed in children or teenagers. In recent years, there has been increasing controversy about the validity of diagnosing children as young as 3 years old with bipolar disorder. At present, bipolar disorder is only officially recognized as a diagnosis in adults.

The drugs are manufactured by Eli Lilly and Co. (LLY) for Zyprexa, AstraZeneca (AZN) for Seroquel and Pfizer (PFE) for Geodon.

Source: FDA