Skip to main content

FDA votes on psychiatric drug approval for children


WASHINGTON The Food and Drug Administration is reviewing three antipsychotic drugs for use in children ages 10 to 17, despite side effects that can lead to greater risk of diabetes.

According to the Associated Press, AstraZeneca, Eli Lilly and Co. and Pfizer's drugs are currently approved for treatment of schizophrenia and bipolar disorder in adults. Although the medications have said to be equally effective amongst children, the FDA shares concern for side effects, including weight gain, increased blood pressure, sleepiness and higher risk of diabetes.

On Tuesday, the companies presented data from a three- to six-week study in which the drugs were compared to placebo. FDA and representatives of the Patient and Consumer Coalition, however, remain unconvinced and critique that research must include possible long-term effects of the antipsychotic drugs.

"We need to hold these drugs to higher standards," said Stephanie Portes-Antoine of the Patient and Consumer Coalition at Tuesday's meeting. "They should be proven safe and effective for long-term use since the treatment will be long-term."

FDA will ask 10 members of its psychiatric advisory committee to discuss the benefits and risks of each medication, followed by the opportunity to vote on the issue. Though FDA is free to diverge from the panel’s advice, they typically do not.

This ad will auto-close in 10 seconds