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Antipsychotic drugs appear to work in kids

WASHINGTON - Three antipsychotic drugs appear to work in children and teens but their risks must be weighed as the makers seek to promote them for younger patients, the head of the U.S. Food and Drug Administration’s psychiatric division said in a memo released on Friday.

The FDA has yet to make a final decision on whether to approve drugs made by AstraZeneca, Pfizer and Eli Lilly and Co for children and teens with schizophrenia or bipolar disorder.

An FDA panel is to meet next week to give recommendations on the companies’ bid to promote the drugs for children and teenagers with schizophrenia or bipolar disorder.

Doctors can already prescribe the medications for children, but FDA approval would allow the manufacturers to market them more widely.

The drugs, known as atypical antipsychotics, are widely used to treat various psychiatric conditions but have come under scrutiny for links to weight gain.

“We generally are in agreement that the sponsors have provided adequate support to suggest effectiveness,” FDA’s Thomas Laughren wrote in the memo released on Friday.

He added that the safety of the drugs in children appeared “to be qualitatively similar to those observed with these drugs in adult patients.”

Still, “all of these drugs also have significant risks that must be considered,” Laughren added.

Pfizer has applied for approval of Geodon for acute treatment of bipolar disorder in 10- to 17-year-olds. One FDA reviewer urged the agency to extend a current heart-related warning to include children.

FDA clinical reviewer Mark Ritter said Geodon’s prescribing instructions should mention that children also face risks of QT prolongation, a type of irregular heartbeat that in rare cases increases the risk of sudden death.

Ritter said data suggest children are “at least as sensitive” to QT prolongation effects associated with Geodon “and may potentially be at greater risk” for serious irregular heartbeats.

Pfizer said the drug was well-tolerated overall.

Lilly is asking for clearance to sell Zyprexa for treating episodes of bipolar disorder or schizophrenia in adolescents ages 13 to 17 after other treatments are tried first. FDA staff backed such “second line” use, noting the drug’s higher risk for weight gain and other side effects.

AstraZeneca is seeking approval of Seroquel for acute treatment of schizophrenia in teens, and for acute treatment of bipolar mania in ages 10 to 17.