The U.S. Food and Drug Administration (FDA) handed Eli Lilly & Co. approval to market its best-selling medication Zyprexa to teens with schizophrenia or bipolar disorder.
The FDA approved the drug for treatment of schizophrenia or manic/mixed episodes associated with bipolar I disorder in adolescents aged 13-17 years old.
The recommended starting dose for adolescents is lower than that for adults.
The updated Zyprexa label states that clinicians should take into consideration the increased potential for weight gain and hyperlipidemia in adolescents compared to adults and the potential for long-term risks, which in many cases, may lead them to consider prescribing other drugs first in adolescents.
The Zyprexa label provides additional guidance to physicians that medication therapy for pediatric schizophrenia or bipolar I disorder should be initiated only after a thorough diagnostic evaluation and careful consideration of the risks associated with medication treatment.
Earlier this year, a Journal of the American Medical Association study found that teens are more prone to weight gain when taking atypical antipsychotic drugs than adults. The study found children and teens can gain nearly 20 pounds and become obese within just 11 weeks. The FDA said it will examine the weight-gain side effect in children at a hearing next week.
Zyprexa was Lilly’s top-selling medication in 2008, with sales of $4.7 billion.
Source: News wire