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A photo of a man who has his blood pressure tested. The FDA has found NDEA, another known carcinogen, in some lots of valsartan medications used to treat heart problems and hypertension. ( Gerald Oswald | pixabay )
The US Food and Drug Administration has found more unexpected impurities in several pills containing the recalled valsartan drug.
Valsartan is a common ingredient of medication for people who suffer from hypertension and heart failure. However, in July, it was recalled that public health officials found that it was contaminated with N-nitrosodimethylamine or NDMA, an organic chemical used in the manufacture of rocket fuel and a sub- product of the manufacture of pesticides. It is also a suspected carcinogen.
In a press release issued and released on Thursday, Sept. 13, the FDA informed the public of the results of an ongoing investigation into valsartan.
FDA adds 3 new recalled Valsartan medications
According to the latest series of tests, another unexpected impurity was detected in three batches of valsartan medications recalled by Torrent Pharmaceuticals. The impurity called N-nitrosodiethylamine or NDEA is also a known carcinogen to animals and humans. All three products have been added to the FDA's growing list of valsartan recalls.
Zhejiang Huahai Pharmaceuticals was the first to find NDEA in several batches of its valsartan-based medicines. In response, the FDA has re-tested all valsartan medications – both recalled and currently available on the market – in three of Torrent Pharmaceuticals' products: 160 mg (lot BV47D001) and 320 mg (lots BV48D001 and BV48D002).
All ZHP valsartan products are not recalled.
"As we continue to investigate the cause of impurities in products containing valsartan, our scientists are testing these products to better understand these impurities and to ensure that they are not present in others." products, "said Scott Gottlieb, FDA Commissioner.
"We are also taking steps to ensure that we rigorously monitor manufacturing processes to reduce the likelihood of introducing impurities into other products."
What to do if a patient has taken valsartan
People who have been prescribed valsartan and are worried about taking a contaminated lot should consult a pharmacist or their doctor first. Since all valsartan medications are not contaminated with NDMA and NDEA, they may be able to replace them.
Public health officials advise patients to continue taking their medications unless a professional asks them to stop. Health Canada has stated that the increased risk of cancer caused by impurities comes from long-term exposure. There is no immediate risk to the health of anyone who has taken drugs that are contaminated with valsartan.
The FDA is working with Health Canada and the European Medicines Agency to determine the cause of the problem.
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