美国Regent 公司1批肾上腺素因褪色及颗粒物而被召回

圣路易斯(MD Consult)——2012年4月24日，美国食品药品管理局(FDA)宣布，美国Regent公司正在主动从全国召回1个批次(批号# 1395)的肾上腺素1:1000注射液，规格为1 ml安瓿。该公司是在发现部分安瓿存在褪色问题和肉眼可见的微小颗粒物后发起这次召回的。

静脉注射含有颗粒物的溶液，可能导致的不良事件包括：破坏肺内小血管的血流，引起局部炎症，以及导致肉芽肿形成。静脉或皮下注射含有颗粒物的溶液，可能引起肌肉和脂肪组织损伤。与脊柱内注射含有颗粒物的溶液相关的不良事件尚不清楚，但可能包括炎症。

注射肾上腺素适用于缓解由支气管痉挛导致的呼吸窘迫，可迅速缓解由药物和其他过敏原引起的超敏反应，还可延长浸润麻醉剂的作用时间。其心脏效应也可被用于使心搏骤停患者恢复心律。此外，该产品还被用作止血剂。

该产品标签的警告部分强调，如果药液呈浅桃色或比浅黄色更深，或者发现存在沉淀物，则不得使用。

与使用该产品相关的不良反应，应报告至美国Regent公司和FDA的MedWatch不良事件报告系统。

爱思唯尔  版权所有

ST LOUIS (MD Consult) - On April 24, 2012, the US Food and Drug Administration (FDA) announced that American Regent is conducting a nationwide voluntary recall of 1 lot (lot# 1395) of epinephrine for injection 1:1000, in 1-mL ampules. The recall was initiated after discovery of discoloration and small visible particles in some ampules from this lot.

Potential adverse events after intravenous administration of solutions containing particulates may include disruption of blood flow within small blood vessels in the lung, localized inflammation, and granuloma formation. Muscle and adipose tissue damage may occur by the intramuscular or subcutaneous injection of solutions containing particulates. Adverse events associated with use of intraspinal injections of a product containing particles are unknown, but may cause inflammation.

Epinephrine for injection is indicated to relieve respiratory distress resulting from bronchospasm, to provide rapid relief of hypersensitivity reactions to drugs and other allergens, and to prolong the action of infiltration anesthetics. Its cardiac effects may be of use in restoring cardiac rhythm in cardiac arrest. The product is also used as a hemostatic agent.

The product label warns that the solution should not be used if its color is pinkish or darker than slightly yellow, or if it contains precipitate matter.

Any adverse reactions experienced with the use of this product should be reported to American Regent and to the FDA's MedWatch Adverse Event Reporting Program.