A common blood-pressure medicine is being recalled due to possible cancer risk
Carcinogenic agents were found in some widely used medications to treat blood pressure and heart failure, motivating the U.S. Food and Drug Administration to issue a recall for them.
The drugs that contain the active ingredient valsartan reportedly present an impurity identified as N-nitrosodimethylamine (NDMA) and it might be linked to the development of cancer in humans, according to the federal agency's website.
FDA announced the voluntary recall in a press release on July 13, alerting the public and the healthcare professionals about the risks associated with the products in question.
As the release reads, not all products containing the ingredient are been recalled, as valsartan in its uncorrupted form remains safe to human use. Read more on our Twitter account @amomama_usa.
The unexpected presence of NDMA in the signaled medications was probably caused by irregularities during the manufacture of the active substance.
‘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,’ explained FDA Commissioner Scott Gottlieb.
Measures are being taken to remove the problematic medications from the market as soon as possible, but given that these medicines are used to treat very serious chronicle conditions they advise the patients under treatment to continue taking them until a replacement is available.
‘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,’ added Gottlieb.
Similar actions are being taken in China by the National Health and Family Planning Commission, as the products containing impure valsartan were manufactured by Zheijan Huahai Pharmaceutical in the city of Linhai.
Below we are listing the companies that are affected by this inconvenient, along with the medicines that contain the impurity:
-Major Pharmaceuticals – Valsartan
-Solco Healthcare – Valsartan, Valsartan/Hydrochlorothiazide (HCTZ)
-Teva Pharmaceuticals Industries Ltd. – Valsartan, Valsartan/ Hydrochlorothiazide (HCTZ)
The FDA is already working with the listed companies in order to reduce or eliminate NDMA from future products.
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