FDA检测已确认活性成分中效价不一致 20180817

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FDA testing confirmsinconsistent potency in the active ingredient

FDA检测已确认活性成分中效价不一致

[8/17/2018]

Julia法规翻译

FDA is alerting active pharmaceutical ingredient (API) repackagers and distributors, finished drug manufacturers, and compounders that Sichuan Friendly Pharmaceutical Co. Limited,China, is recalling certain lots of porcine thyroid API due to inconsistent quality of the API. FDA recommends that manufacturers and compounders not use Sichuan Friendly’s porcine thyroid API received since August 2015. This thyroid API comes from porcine (pig) thyroid glands and is used to make a non-FDA approved  drug product, composed of levothyroxine and liothyronine, to treat hypothyroidism (underactive thyroid).

FDA警示API再包装商和分销商、制剂生产商和药房，中国四川菲德力制药由于API质量不一致正在召回指定批号的甲状腺粉(猪)API。FDA建议生产商和药房不要使用2015年8月以后收到的四川菲德力的甲状腺粉(猪)API。该甲状腺粉API来源于猪甲状腺，被用于生产非FDA批准的药品，含有左旋甲状腺素和碘塞罗宁，用于治疗甲状腺机能减退（甲状腺功能不足）。

FDA laboratory testing confirmed the Sichuan Friendly API has inconsistent levels of the active ingredients – levothyroxine and liothyronine – and should not be used to manufacture or compound drugs for patient use. Risks associated with over or under treatment of hypothyroidism could result in permanent or life-threatening adverse health consequences.

FDA实验室检测确认了四川菲德力的API中活性成分左旋甲状腺素和碘塞罗宁水平不一致，不能用于生产或配制药品供患者使用。甲状腺机能减退治疗过度或不足引发的风险可能会导致永久或威胁生命的不良健康后果。

FDA placed Sichuan Friendly on import alert 66-40 on March 22, 2018, based on current good manufacturing practice (CGMP) deviations observed during an FDA inspection.

鉴于FDA检查期间发现的CGMP缺陷，FDA已于2018年3月22日将四川菲德力置于进口禁令66-40项下。

However, FDA confirmed Sichuan Friendly’s thyroid API remains in the U.S. supply chain. This API and the drug products made from it, present a safety risk to patients. Sichuan Friendly API may be repackaged and/or relabeled before it is further distributed, and not all of the repackaged/relabeled API identifies Sichuan Friendly as the original API manufacturer. Therefore, manufacturers and compounders who make levothyroxine and liothyronine drug products should contact their API supplier to verify the actual manufacturer of the thyroid API they received before using it. Sichuan Friendly’s products may be labeled as “Thyroid Powder” or “Thyroid Powder USP.”  

但是，FDA确认四川菲德力的甲状腺粉API仍在美国供应链中存在。此API和其所制药品会对患者产生安全风险。四川菲德力的API在进一步销售之前可能会被重新包装和/或重新标签，而并不是所有重新包装/重新标签之后的API都会标示四川菲德力为原始API生产商。因此，生产左旋甲状腺素和碘塞罗宁的生产商和药房应联系其API供应商，以在使用之前确认其所收到的甲状腺粉API的真实生产商。四川菲德力的产品可能会被标示为“甲状腺粉”或“甲状腺粉USP”。

Additionally, manufacturers and compounders who have received API made by Sichuan Friendly should quarantine the API and associated drug products. If manufacturers and compounders have API or drug products made from Sichuan Friendly API, FDA requests these companies contact FDA’s regional offices.

另外，已收到四川菲德力生产的API的制剂生产商和药房应隔离该API及相关制剂。如果生产商和药房持有四川菲德力的API或制剂，FDA要求这些公司联系FDA的地方办公室。

FDA recommends patientstalk to their health care professional before they stop taking their combination levothyroxine and liothyronine thyroid medicine. FDA also recommends that patients discuss FDA-approved hypothyroidism treatment options with their doctors, as combination levothyroxine and liothyronine products are not FDA-approved.

FDA建议患者在停止服用其左旋甲状腺素和碘塞罗宁甲状腺素复方药之前与其卫生专家沟通。FDA亦建议患者与其医生讨论FDA已批准的甲状腺机能减退治疗选择，因为左旋甲状腺素和碘塞罗宁药品并非FDA批准药品。

FDA advises patients notto use porcine thyroid medicine labeled as Westminster

FDA建议患者不要使用标示为Westminster的甲状腺粉(猪)药品

Additionally, on August9, 2018, Westminster Pharmaceuticals LLC voluntarily recalled all unexpired lots of levothyroxine and liothyronine (thyroid tablets) 15mg, 30mg, 60mg, 90mg, and 120mg. These products were made using API from Sichuan Friendly. FDA laboratory testing confirmed inconsistent levels oflevothyroxine and liothyronine. Therefore, FDA recommends patients not use porcine thyroid drug products made by Westminster.

另外，在2018年8月9日，Westminster Pharmaceuticals LLC主动召回了所有在效期内的15mg、30mg、60mg、90mg和120mg左旋甲状腺素和碘塞罗宁（甲状腺素片剂）批号。这些药品是使用四川菲德力的API生产的。FDA实验室检测确认了其中左旋甲状腺素和碘塞罗宁水平不一致。因此，FDA建议患者不要使用Westminster生产的甲状腺粉(猪)药品。

FDA inspection and adverse event reporting

FDA现场检查和不良事件报告

FDA inspected the Sichuan Friendly’s facility in 2017 and discovered serious quality deficiencies, including:

FDA于2017年检查了四川菲德力的工厂，发现了严重的质量缺陷，包括：

• use of an incorrect formula to calculate the potency of the API, which means there may be inconsistent levels of levothyroxine and liothyronine present in the API, and
• 使用错误的配方计算API的效价，这表示API中的左旋甲状腺素和碘塞罗宁水平可能不一致，且
• multiple batches of API released with certificates of analysis containing inaccurate potency and stability data, and
• 多批API放行时COA中效价结果和稳定性数据不准
• no stability data to support the claimed shelf-life of the API.
• 没有稳定性数据支持所声明的API货架期
  
  

Health care professionals and patients are encouraged to report any adverse eventsassociated with porcine thyroid medications to the FDA’s MedWatch Adverse Event Reporting program:

FDA鼓励卫生专家和患者向FDA的MEDWATCH报告甲状腺粉(猪)用药有关的不良事件

• Complete and submit the report online at www.fda.gov/medwatch/report.htm; or
• 在线填写并提交报告
• Download and complete the form, then submit it via fax at 1-800-FDA-0178.
• 下载并填写表格，通过传真1-800-FDA-0178提交
  
  

FDA will continue to provide additional information as it becomes available.

一旦有更新消息，FDA会持续更新

For more information, please visit: Recall of Porcine Thyroid API.

更多信息参见甲状腺粉(猪)原料药召回

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