ST LOUIS (MD Consult) - On December 2, 2009, the US Food and Drug Administration (FDA) announced that Sanofi-Aventis has notified health care professionals of changes made to the Warnings and Overdosage sections of the prescribing information for Norpramin (desipramine hydrochloride). Norpramin is indicated for the treatment of depression.

The new safety information states that extreme caution should be used when this drug is given to patients with a family history of sudden death, cardiac dysrhythmias, and cardiac conduction disturbances, and that seizures may precede cardiac dysrhythmias and death in some patients. The revised label also states that desipramine overdoses have resulted in a higher death rate compared with overdoses of other tricyclic antidepressant medications.

Sanofi-Aventis is encouraging clinicians to report any adverse events experienced by patients receiving Norpramin to the company by calling 1-800-633-1610 (option #2). Alternatively, this information may be reported to FDA's MedWatch reporting system.

圣路易斯(MD Consult)——2009年12月2日，美国食品药品管理局(FDA)宣布，赛诺菲-安万特公司已向医务工作者发布通告，对地昔帕明(盐酸去甲丙咪嗪)处方信息中”警告和药物过量”栏目进行更新。地昔帕明被批准用于治疗抑郁症。

新的安全性信息声明，当该药物用于有猝死、心律不整和心脏传导异常家族史的患者时需格外谨慎。一些患者可能发生抽搐，随后出现心律不整，甚至发生死亡。修改后的标签中还指出，与其他三环类抗抑郁药相比，地昔帕明过量导致的死亡率更高。

 

赛诺菲-安万特公司鼓励临床医生将接受地昔帕明治疗患者发生的任何不良事件向公司报告，可拨打电话1-800-633-1610 (或#2)，也可将信息报告至FDA的MedWatch报告系统。