1批二氢可待因酮/对乙酰氨基酚复方片被召回

圣路易斯(MD Consult)——2012年9月10日，美国食品药品管理局(FDA)和Endo Health子公司Qualitest联合宣布，主动召回1个批次的重酒石酸二氢可待因酮和对乙酰氨基酚(10 mg/500 mg)每瓶100片的瓶装片剂。这一批次的某些片剂可能超出重量规格，从而可导致其成分重酒石酸二氢可待因酮和对乙酰氨基酚的效力过高。迄今为止尚无损害报告。

受累批次的瓶装片剂可能包含剂量过高的对乙酰氨基酚，结果可能导致消费者服用超过意向剂量的对乙酰氨基酚。无意服用这些对乙酰氨基酚含量增高的片剂可能导致肝脏毒性，尤其是在同时接受其他含对乙酰氨基酚药物治疗的患者、肝功能不全患者或每日摄入3杯以上含酒精饮料的患者。产品标签中警告消费者，使用过量的对乙酰氨基酚可能导致严重肝脏损害，有时甚至需要肝脏移植或导致死亡。

服用高于意向剂量的二氢可待因酮可能导致不良反应(如镇静或呼吸抑制)程度加重和发生频率增加，尤其是在老年患者、有严重肾脏或肝脏功能受损患者以及同时服用可能发生相互作用的药物(如其他镇静药或某些抗抑郁药)的患者中。

因使用应召回产品而发生的不良反应可报告至FDA的MedWatch不良事件报告系统。

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ST LOUIS (MD Consult) - On September 10, 2012, the US Food and Drug Administration (FDA) and Qualitest, a subsidiary of Endo Health, announced a voluntary recall of 1 lot (lot# C1440512A, expiration date 12/13) of hydrocodone bitartrate and acetaminophen tablets (10 mg/500 mg) in 100-count bottles. Some tablets from this lot may exceed the weight specification and could be super-potent for the ingredients hydrocodone bitartrate and acetaminophen. No injuries have been reported to date.

Bottles from the affected lot may contain tablets that have a higher dosage of acetaminophen, and as a result, it is possible that consumers could take more than the intended acetaminophen dose. Unintentional administration of tablets with increased acetaminophen content could result in liver toxicity, especially in patients receiving other acetaminophen-containing medications, patients with liver dysfunction, or persons who consume more than 3 alcoholic beverages a day. The product label warns consumers that acetaminophen overdose can potentially cause severe liver damage, at times resulting in liver transplant or death.

Taking a higher dose of hydrocodone than intended could result in an increase in the severity or frequency of adverse effects, such as sedation or respiratory depression, particularly in patients who are elderly, patients with severe kidney or liver impairment, or patients who are also taking interacting medications (eg, other sedating medications or certain antidepressants).

Adverse reactions experienced with use of the recalled product may be reported to the FDA's MedWatch Adverse Event Reporting Program.