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Advisors to the US medicines watchdog have played down the side effects of three psychiatric drugs and recommended them for use by people aged as young as 10 years old.
A panel of psychiatric experts looking into drugs from psychiatric drugs for treating schizophrenia and bipolar disorder advised the Food and Drug Administration (FDA) they were safe for use by patients aged 10 to 17, despite side effects linked to an increased risk of diabetes.
A spokesman for the FDA, which is not required to accept the group’s advice but usually does, said: “We’ll take all of this into consideration, but I can’t make any promises about when we’ll take action.
The treatments – already approved for use by adults with psychiatric conditions – carry with them the risk of weight gain, high blood sugar and sleepiness.
The panel largely ignored calls from patient and consumer groups for the companies to conduct longer studies of the drugs’ side effects.
It voted 11-4 that Lilly’s drug Zyprexa is safe for treating bipolar, despite evidence the drug causes significantly more weight gain than other treatments.
AstraZeneca and Lilly are seeking approval of their drugs – Seroquel and Zyprexa – for adolescents with schizophrenia and bipolar mania, also called manic depressive disorder. Pfizer wants to market its pill Geodon for bipolar patients ages 10 to 17.
Copyright Press Association 2009
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“It would be advisable to carry out experimental studies focusing on effectiveness or toxicology data in pediatric patients before validating an indication for this therapy among the pediatric patient population” – Anna, Carollo, ISMETT