The U.S. Food and Drug Administration is alerting health care professionals and patients of a voluntary recall of several drug products containing the active ingredient valsartan, used to treat high blood pressure and heart failure. This recall is due to an impurity, N-nitrosodimethylamine (NDMA), which was found in the recalled products. However, not all products containing valsartan are being recalled. NDMA is classified as a probable human carcinogen (a substance that could cause cancer) based on results from laboratory tests. The presence of NDMA was unexpected and is thought to be related to changes in the way the active substance was manufactured.
美国食品和药物管理局正在提醒医疗保健专业人员和患者自愿召回几种含有活性成分缬沙坦的药品，用于治疗高血压和心力衰竭。 这次召回是由于召回产品中发现的杂质N-亚硝基二甲胺（NDMA）。 但是，并非所有含有缬沙坦的产品都被召回。 根据实验室测试的结果，NDMA被归类为可能的人类致癌物（一种可能导致癌症的物质）。 NDMA的存在是出乎意料的，并且被认为与活性物质的制造方式的变化有关。
The FDA’s review is ongoing and has included investigating the levels of NDMA in the recalled products, assessing the possible effect on patients who have been taking them and what measures can be taken to reduce or eliminate the impurity from future batches produced by the company.
“The FDA is committed to maintaining our gold standard for safety and efficacy. That includes our efforts to ensure the quality of drugs and the safe manner in which they’re manufactured,” said FDA Commissioner Scott Gottlieb, M.D. “When we identify lapses in the quality of drugs and problems with their manufacturing that have the potential to create risks to patients, we’re committed to taking swift action to alert the public and help facilitate the removal of the products from the market. As we seek the removal of certain drug products today, our drug shortages team is also working hard to ensure patients’ therapeutic needs are met in the United States with an adequate supply of unaffected medications.”
FDA的审查正在进行中，其中包括调查召回产品中NDMA的水平，评估对服用这些产品的患者可能产生的影响，以及可采取哪些措施来减少或消除公司生产的未来批次中的杂质。
“FDA致力于维护我们的安全性和有效性的黄金标准。这包括我们为确保药品质量及其制造的安全方式所做的努力，“FDA专员Scott Gottlieb医师表示，”当我们确定药品质量的缺失和制造方面的问题时，有可能造成对患者构成风险，我们承诺采取迅速行动提醒公众，并帮助促进从市场上移除产品。当我们今天寻求去除某些药物产品时，我们的药物短缺团队也在努力确保在美国满足患者的治疗需求，同时提供足够的未受影响的药物。“
Information for Patients and Health Care Professionals
-
Because valsartan is used in medicines to treat serious medical conditions, patients taking the recalled valsartan-containing medicines should continue taking their medicine until they have a replacement product.
-
To determine whether a specific product has been recalled, patients should look at the drug name and company name on the label of their prescription bottle. If the information is not on the bottle, patients should contact the pharmacy that dispensed the medicine.
-
If a patient is taking one of the recalled medicines listed below, they should follow the recall instructions provided by the specific company. This information will be posted to the FDA’s website.
-
Patients should also contact their health care professional (the pharmacist who dispensed the medication or doctor who prescribed the medication) if their medicine is included in this recall to discuss their treatment, which may include another valsartan product not affected by this recall or an alternative treatment option.
The companies listed below are recalling all lots of non-expired products that contain the ingredient valsartan supplied by a third-party. Not all valsartan-containing medicines distributed in the United States have valsartan active pharmaceutical ingredient (API) supplied by this specific company. The supplier has stopped distributing its valsartan API and the FDA is working with the affected companies to reduce or eliminate the valsartan API impurity from future products.
Recalled Products
患者和医疗保健专业人员的信息
由于缬沙坦用于治疗严重疾病的药物，服用含有缬沙坦的药物的患者应该继续服药，直到他们有替代产品。
为确定特定产品是否已被召回，患者应查看其处方瓶标签上的药品名称和公司名称。如果信息不在瓶子上，患者应该联系分发药物的药房。
如果患者正在服用下列召回的药物之一，则应遵循特定公司提供的召回说明。该信息将发布在FDA的网站上。
患者还应该联系他们的医疗保健专业人员（分发药物的药剂师或开药的医生），如果他们的药物包括在本次召回中讨论他们的治疗，可能包括另一个不受此次召回影响的缬沙坦产品或替代治疗选项。
下面列出的公司正在召回所有含有第三方提供的缬沙坦成分的非过期产品。并非所有在美国销售的含缬沙坦的药物都含有由该特定公司提供的缬沙坦活性药物成分（API）。供应商已停止销售其缬沙坦API，FDA正在与受影响的公司合作，以减少或消除未来产品中的缬沙坦API杂质。
召回产品：
备注：
缬沙坦/氢氯噻嗪（HCTZ）Solco Healthcare
缬沙坦/氢氯噻嗪（HCTZ）Teva Pharmaceuticals Industries Ltd.
“We have carefully assessed the valsartan-containing medications sold in the United States, and we’ve found that the valsartan sold by these specific companies does not meet our safety standards. This is why we’ve asked these companies to take immediate action to protect patients,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research.
The FDA will continue to investigate this issue and provide additional information when it becomes available. The agency encourages patients and health care professionals to report any adverse reaction to the FDA’s MedWatch program.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
“我们仔细评估了在美国销售的含缬沙坦的药物，我们发现这些特定公司销售的缬沙坦不符合我们的安全标准。这就是我们要求这些公司立即采取行动保护患者的原因，“FDA药物评估和研究中心主任Janet Woodcock说。
FDA将继续调查此问题，并在可用时提供其他信息。该机构鼓励患者和医疗保健专业人员报告对FDA MedWatch计划的任何不良反应。
FDA是美国卫生与公众服务部的一个机构，通过确保人用和兽药，疫苗和其他人用生物制品以及医疗器械的安全性，有效性和安全性来保护公众健康。该机构还负责我国食品供应，化妆品，膳食补充剂，发放电子辐射的产品以及调节烟草制品的安全性。
始发于微信公众号：