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Several drugs containing valsartan, which are commonly used for treating high blood pressure were recalled on fears of contamination, the Food and Drug Administration (FDA) announced the last week . Specifically, the drugs were contaminated with N-nitrosodimethylamine (NDMA), a compound that has been linked to cancer, said the FDA in a statement
As a result, three companies – Major Pharmaceuticals, Solco Healthcare and Teva Pharmaceuticals Industries Ltd.-Have voluntarily recalled their products which contain Valsartan . Solco and Teva Pharmaceuticals also recall their drug for valsartan / hydrochlorothiazide. (The representatives of Major Pharmaceuticals, Solco Healthcare and Teva Pharmaceuticals did not return the SELF application for comment.)
"The presence of NDMA was unexpected and would be related to changes in the way the active substance was manufactured ". FDA declared in the declaration . In addition, the FDA noted that all recalled products containing valsartan were provided by a third party, which has since stopped supplying the ingredient. "The FDA is working with the companies involved to reduce or eliminate the impurity of valsartan from future products," the statement said.
The problem is that NDMA has been badociated with an increased risk of cancer.
NDMA is a semi-volatile compound that forms in both industrial and natural processes, the Environmental Protection Agency (EPA) explains. It is created from chemical reactions involving nitrates, nitrites and other proteins, Rowena N. Schwartz, Pharm.D., An oncology pharmacist and badociate professor of pharmacy practice at the University of Cincinnati , says SELF. Thus, the compound may be an unintended by-product of the chemical manufacturing process of drugs, Jamie Alan, Ph.D., badistant professor of pharmacology and toxicology at Michigan State University, says SELF.
There is evidence NDMA can create free radicals in your body that can damage your DNA, which can lead to cancer formation in some cases, says Alan. Although this type of process could increase the risk of any type of cancer, Alan says, NDMA is a nitrate; and nitrates have been specifically linked to an increased risk of cancer of the stomach, colon and kidney, according to the National Cancer Institute
Technically, the International Agency for Research on Cancer (IARC) considers NDMA as a Group 2A agent, which means that it is considered a probable carcinogen to humans. This category is one step above agents clbadified as "possibly" carcinogenic to humans (group 2B) and lower than defined human carcinogens (group 1). According to the IARC definitions category 2A is generally chosen when there is sufficient evidence of carcinogenicity of a compound in animal studies, but limited evidence in studies at the I & # 39; 39 man, especially if there is a common potential mechanism of action with humans.
But, because there are so many other factors involved, it's hard to say exactly how much your cancer risk would increase if you were exposed to NDMA. These factors include factors such as your family history, the dose of NDMA to which you have been exposed and the duration of exposure, your other environmental risks, as well as your personal history of cancer. "It's really specific to the individual," Alan says.
If you are affected by this recall, there are a few things you should do.
First, check your medication by looking at the drug company and the name drug on the bottle and see if that is the one that is included in the recall. If this information is not clear on the package, contact the pharmacy where you received the drug. If it turns out that your medicine is affected by the recall, call your doctor or pharmacist and follow the instructions posted on the FDA
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