(RNN) – A worldwide recall initiated last month for drugs containing the medication valsartan was expanded by the Food and Drug Administration last week and in South Korea on Monday.
The spread of the recall is linked to the presence of a possible cancer-causing impurity, a chemical compound known as NDMA.
Valsartan is a common drug used to treat high blood pressure and some heart conditions. Its brand name, Diovan, produced by Novartis, is unaffected.
The FDA first issued a new list of companies that were affected by tainted valsartan on Thursday. It included four smaller companies - Bryant Ranch Prepack, H J Harkins Company, Proficient Rx, and Northwind Pharmaceuticals - that obtain the drug in bulk from a supplier and repackage it in smaller batches for hospitals and pharmacies
The original July recall had already included a major global drug company, Teva Pharmaceuticals. Two companies that package and distribute Teva drugs, Major Pharmaceuticals and Actavis, were listed in the recall. Others included AvKARE, Remedy Repack, A-S Medication Solutions, and Solco Healthcare.
Teva Pharmaceuticals USA Issues Voluntary Nationwide Recall of Valsartan and Valsartan Hydrochlorothiazide Tablets https://t.co/PFA3Z1Vway
— U.S. FDA (@FDArecalls) July 17, 2018
The impurity has been traced to drugs originating out of China, by a company called Zhejiang Huahai Pharmaceuticals, which supplies drug makers such as Teva the raw chemical valsartan with which to produce generics.
The company’s U.S. subsidiary is located in New Jersey. The New York Times reported, citing a pharmaceutical industry research firm, that one of the companies affected, Solco, is owned by Zheijiang Huahai and controls about 45 percent of the valsartan market in the U.S., as of last year.
“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,” Scott Gottlieb, the FDA commissioner, said after the original recall announcement last month.
People on the drug are advised to look at their bottle labels to see if it comes from one of the affected companies and the FDA says patients "should continue taking their medicine until they have a replacement product."
The FDA’s European counterpart, the European Medicines Agency (EMA), also issued a recall and is conducting a review related to the valsartan produced by Zhejiang Huahai.
The EMA downplayed the risk.
“It is important to note that there is no immediate risk to patients,” the agency said in an update issued on Thursday. “Patients taking the affected medicines who have not yet switched to an alternative should not stop taking their medicines without consulting their doctor or pharmacist.”
On Monday, South Korea expanded its own recall, the Yonhap News Agency reported. The country’s Ministry of Food and Drug Safety recalled 59 more drugs containing valsartan, targeting a drug producer, Daebong, that had obtained the ingredient from a different Chinese company, Zhuhai Rundu Pharmaceuticals.
Taiwan also issued a recall targeting Zhuhai Rundu on Thursday.
It is not clear if Zhuhai Rundu supplies valsartan to any U.S. companies, though on its website it says it sells its products to the U.S. market. It does not have a U.S. subsidiary, though it announced in February plans to set up a unit here.
A list of valsartan products not currently recalled is available on the FDA's website here.
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