FDA-Approved Antipsychotic and Bipolar Medications May Soon Be Available for Children

An advisory panel for the FDA has given its approval for three widely prescribed antipsychotic medications to be used for treating children as young as 10 who are suffering from schizophrenia and bipolar disorder. The drugs—Zyprexa, Seroquel, and Geodon—are already approved for treating adults with these conditions, but the panel has determined after its review that the drugs are safe and effective for children as well.

While the FDA doesn’t have to follow the panel’s recommendation, they will consider their advice and make their final decision for the three medications. Even though the drugs are already being prescribed by some doctors for children, the FDA’s approval would allow drug companies to market their drugs specifically for treating children and teenagers in addition to adults. Pfizer is only seeking approval for its drug Geodon to be used in treating bipolar disorder, while Eli Lily and AstraZeneca are seeking approval of their drugs Zyprexa and Seroquel to be used in treating both schizophrenia and bipolar disorder. There are already two similar drugs approved for use in children, Johnson & Johnson’s Risperdal and Bristol-Meyers Squibb’s Abilify.

Schizophrenia, a condition that can cause hallucinations and delusions, and bipolar disorder which is characterized by dramatic mood swings, can be debilitating to anyone suffering from the conditions. It seems the side effects of these drugs, including weight gain and sleepiness, are trumped by their positive effects. However, there are some concerns as to the long-term effects of the drugs on the children, especially since the drugs have only been tested for short lengths of time. Ruth Day, a researcher at Duke University said, “I’m concerned about the lack of true long-term studies” especially in children and teenagers whose odds of long lives are high.

Since 2001, antipsychotic medicines used by people under twenty years of age have more than doubled according to Medco Health Solutions Inc. Doctors are able to prescribe medication based on their discretion to children and for reasons the drugs weren’t actually FDA approved for. The three drugs under review are already being prescribed by some doctors to middle-aged children. These drugs had combined recorded sales of $14.6 billion in 2008, comprising the top-selling class of drugs in the U.S., according to IMS Health.

The FDA gave no indication as to when they will release their final decision. The patients’ representative on the panel Margy Lawrence said the patients are more concerned about their brains working correctly than the potential side effects of the drugs. Still, some doctors and researchers are concerned in regards to what they don’t know about the drugs effects over time.