The U.S. Food and Drug Administration (FDA) issued an update on Dec. 6 about its ongoing recall of heart and blood pressure medication due to impurities that could cause cancer.
It said Mylan Pharmaceuticals “is expanding its voluntary recall to include all lots of non-expired valsartan-containing products due to trace amounts of N-Nitrosodiethylamine (NDEA) in the valsartan active pharmaceutical ingredient (API) manufactured by” by Mylan Inc.
It said an additional 104 lots of the drugs include 26 lots of amlodipine and valsartan tablets, another 51 lots of valsartan tablets, and 27 lots of valsartan and hydrochlorothiazide tablets.
They were distributed across the United States from March 2017 until November 2018, the FDA said.
Alternative medications are possible to use, but Mylan said patients should consult their doctor or pharmacist first before stopping their current medication.
“Out of an abundance of caution, these products are being recalled due to detected trace amounts of an impurity, N-nitrosodiethylamine (NDEA) contained in the API Valsartan, USP, manufactured by Mylan Laboratories Limited. NDEA is a substance that occurs naturally in certain foods, drinking water, air pollution, and industrial processes, and has been classified as a probable human carcinogen according to the International Agency for Research on Cancer (IARC),” an earlier FDA release said.
The valsartan recall started over the summer, with FDA officials blaming a Chinese drugmaker for introducing the impurities into the medication. Since then, questions have been raised about the purity and quality of Chinese-manufactured drugs being imported into the United States. While Mylan is based in the United States, the bulk of the valsartan-containing products were made by China’s Zhejiang Huahai Pharmaceuticals, a bulk manufacturer.
Valsartan is used to treat high blood pressure and heart problems.
“Patients who are on valsartan should continue taking their medication, as the risk of harm to the patient’s health may be higher if the treatment is stopped immediately without any alternative treatment,” the FDA said.
Valsartan-containing medicine, manufactured by a Chinese firm, was subject to a significant recall over the summer.
Zhejiang Huahai Pharmaceuticals, a bulk manufacturer of the heart and blood pressure medicine valsartan, recalled the product in the United States in July after the presence of N-nitrosodimethylamine (NDMA) was found.
The FDA said it was halting imports after it found major manufacturing process issues during its inspection of Huahai’s plant, saying the freeze on the imports would remain in place until the Chinese manufacturer determines how the impurities were introduced and improve its quality control systems, Reuters reported two months ago.
“There is a lack of trust in medicines made in China now,” Rosemary Gibson, a senior adviser at The Hastings Center and an author of several books on health care issues, told The Epoch Times several months ago about the recall.
Zhejiang Huahai Pharmaceutical sold some $50 million worth of valsartan in 2017 alone.
“The public wants their medicine to be safe. This carcinogen hidden in valsartan raises the question whether other products that are made in China have been made contrary to the global standard we came to accept,” Gibson explained. “We need to view medicine as a strategic asset, just like how we view oil and energy supply. A strategic asset is something that will make our country fall apart if we don’t have it.”