一批避孕药Estarylla因包装问题被召回

圣路易斯(MD Consult)——2013年7月5日，美国食品药品管理局(FDA)宣布，山德士公司在收到一位消费者关于在一排活性药片中发现一片安慰剂的报告后，正在主动召回这一批次的Estarylla(诺孕酯+炔雌醇)片剂。Estarylla是一种口服避孕药。

山德士公司目前尚未收到任何相关不良事件报告。内部医学评估的结论为，发生不良健康事件的可能性非常低，原因是包装缺陷极易被发现，并且在漏服一片蓝色(活性)片剂后发生妊娠的风险很低。根据包装说明书的描述，安慰剂为绿色。该产品的规格为每个纸盒含3板泡罩卡，每板泡罩卡含28枚药片。

如发生与使用该产品相关的不良事件，应报告至FDA的MedWatch不良事件报告系统。

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ST LOUIS (MD Consult) - On July 5, 2013, the US Food and Drug Administration (FDA) announced that Sandoz is conducting a voluntary recall of 1 lot (lot# LF01213A, expiration date 02/2014) of Estarylla (norgestimate and ethinyl estradiol) after the company received a customer report that a placebo tablet was present in a row of active tablets in 1 pack of product. Estarylla is an oral contraceptive.

Sandoz is not aware of any reports to date of related adverse events. An internal medical assessment concluded that the probability of adverse health events is minimal, because the packaging flaw is easily visible and the risk of pregnancy occurring after non-administration of 1 blue (active) tablet is low. According to the package insert, the placebo tablets are green. The product is supplied in cartons containing 3 blister cards of 28 tablets each.

Adverse events related to use of this product should be reported to the FDA's MedWatch Adverse Event Reporting Program.