FDA warns API manufacturer involved in valsartan recall, provides information for patients taking these medications

  • Posted on: 14 December 2018
  • By: Shalini.Sharma

The U.S. Food and Drug Administration  released a  warning letter  issued to Zhejiang Huahai Pharmaceutical Co. Ltd. (ZHP), in Linhai, Taizhou Zhejiang China, the manufacturer of the active pharmaceutical ingredient (API) found in valsartan that is the subject of an ongoing FDA investigation into probable cancer-causing impurities in certain commonly prescribed heart medicines. The letter outlines several manufacturing violations at ZHP’s Chuannan facility, including impurity control, change control and cross contamination from one manufacturing process line to another. The warning letter is another step forward in the ongoing investigation. The agency is still looking into the root cause of the impurity.

The ZHP facility manufactures API including valsartan, a drug in the angiotensin II receptor blocker (ARB) class used to treat high blood pressure and heart failure. On September 28, the FDA also put this facility on import alert, stopping all API made there and finished drug products made using its API from legally entering the U.S. The agency put ZHP on import alert based, in part, on high levels of impurities found in ZHP’s API.

The FDA announced recalls of valsartan beginning in July due to the presence of N-Nitrosodimethylamine (NDMA) in API supplied by ZHP. Subsequent international investigations expanded to include all manufacturers of API and finished drugs in the ARB class and have resulted in additional recalls of valsartan, irbesartan, and losartan-containing products found to contain NDMA and N-Nitrosodiethylamine (NDEA) – both known animal and suspected human carcinogens. 

There may be confusion regarding which products are affected by ARB recalls and which are not, especially concerning the most recent U.S. recalls of valsartan-containing products using API manufactured by Mylan that tested positive for unacceptable levels of NDEA. Certain ARB products have been recalled, and certain products that contain ARBs and one or more other active ingredients in a single dosage form have been recalled. It is important to note that the API in these products besides valsartan, irbesartan or losartan are not necessarily under a recall.

The FDA continues to test all ARBs for the presence of impurities and has publicly posted two methods for manufacturers and regulatory agencies around the world to test their ARBs for the unexpected NDMA and NDEA impurities.

Patients taking any recalled ARB should continue taking their current medicine until their pharmacist provides a replacement or their doctor provides an alternative treatment option. It also is important to know that not all ARBs contain NDMA or NDEA, so pharmacists may be able to provide a refill of medication not affected by the recall, or doctors may prescribe a different medication that treats the same condition.

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