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Since last year, the FDA has examined the presence of impurities in various types of medications, which has resulted in several drug recalls over the last few months. In the latest announcement in the matter, the agency says that some units of a popular antihistamine drug against the heartburn called ranitidine may contain low levels of carcinogenic impurity, although that she does not order a product recall at the moment.
Ranitidine medicines are sold under a variety of brands, one of the most popular being "Zantac", a non-prescription and prescription heartburn medication. According to the FDA, N-nitrosodimethylamine (NDMA), a molecule currently classified as "probable carcinogen in humans" in some ranitidine-based products, contains low levels of nitrosamine impurity, which means that it can cause cancer in some people.
Although a number of drug recalls have already been initiated because of nitrosamine impurities, the FDA says that there is no recall of these ranitidine-based drugs for the moment. The reason, says the agency, is due to the low levels of impurity present in the drug.
NDMA contamination is present in the environment, including in food and water. The FDA notes that current levels of ranitidine-based drugs are "barely" higher than those found in commonly available foods. Work is underway to determine the source of this contamination, as well as a survey to determine if NDMA at these low levels poses a health risk to people taking the drug.
Patients taking ranitidine are not advised to stop taking it for the moment, the FDA said in its opinion, though it should be noted that anyone taking the over-the-counter version of the drug may consider switching to to a different type of product for the heartburn if they are concerned. The agency will publish an update on the subject in the future when it will have more information.
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