ST LOUIS (MD Consult) - On January 29, 2010, the US Food and Drug Administration announced that Eli Lilly and Co has sent notification to health care professionals of changes made to the prescribing information for Zyprexa. These changes relate to the drug's indication for use in adolescents (aged 13-17 years) for the treatment of schizophrenia and bipolar I disorder (manic or mixed episodes).
Eli Lilly recommends that medication therapy for pediatric schizophrenia and bipolar I disorder be initiated only after a thorough diagnostic evaluation has been performed and careful consideration has been given to the risks associated with medication treatment. Medication treatment for both pediatric schizophrenia and bipolar I disorder should be part of a total treatment program that often includes psychologic, educational, and social interventions.
When deciding among the alternative treatments available for adolescents, clinicians are being advised to consider the increased potential (in adolescents compared with adults) for weight gain and hyperlipidemia with the use of Zyprexa. Physicians are being reminded to be aware of potential long-term risks when prescribing medications for adolescents, which may lead them to try prescribing other drugs first.
圣路易斯(MD Consult)——2010年1月29日,美国食品药品管理局(FDA)宣布,礼来制药公司已向医务人员发出通知,提醒其注意再普乐(Zyprexa)处方信息的变更。这些变更与药物治疗青少年(13~17岁)精神分裂症和I型双向情感障碍(躁狂或混合型发作)的适应证有关。
礼来公司建议,儿科精神分裂症和I型双向情感障碍的药物治疗只有在进行彻底的诊断评估和慎重考虑药物治疗相关风险后才可开始。儿科精神分裂症和I型双向情感障碍的药物疗法只是整体治疗方案的一部分,这一整体治疗方案通常包含心理、教育及社会干预。
在决定适用于青少年的替代治疗方案时,临床医生被建议应考虑青少年服用再普乐(Zyprexa)后出现体重增加和高脂血症的潜在风险上升(相对于成年人)。当给青少年患者使用该药时,医生也被提醒应注意可能出现长期风险,这可能导致医生先尝试处方其他药物来治疗这类青少年患者。