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FDA Considers Psychiatric Drugs For Kids

By Pharmaceutical Processing | June 9, 2009

WASHINGTON (AP) — Three powerful psychiatric drugs currently approved for adults could soon be available for children, as regulators consider the benefits and risks of the medications. The FDA is scheduled to meet today to consider whether drugs from AstraZeneca PLC, Eli Lilly & Co. and Pfizer Inc. should be approved to treat schizophrenia and bipolar disorder in patients between the ages of 10 and 17. The drugs already are approved to treat those conditions in adults. FDA reviewers said in documents posted online last week that the drugs appear to be effective for adolescents and children, though they have concerns about exposing younger patients to the drugs’ side effects. The drugs are known to cause weight gain, high blood sugar and movement disorders among other problems. Discussion is expected to center around whether those side effects pose greater risks to children than adults. The companies are expected to present safety and effectiveness data Tuesday, followed by discussion and recommendations by an outside panel of experts on Wednesday. The FDA is not required to follow the advice of its experts, though it usually does. AstraZeneca and Lilly are seeking permission to market their drugs — Seroquel and Zyprexa, respectively — for adolescents with schizophrenia and bipolar mania, also called manic depressive disorder. Pfizer is seeking approval to market its pill Geodon for bipolar disorder. With only two anti-psychotic drugs currently approved for younger patients, a positive decision for the three drugs would significantly increase competition in the space — and expand sales of products that already are big sellers. Anti-psychotic drugs were the top-selling group of prescription medications in the U.S. last year with sales of $14.6 billion, according to health care analysis firm IMS Health.

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