The US Food and Drug Administration (FDA) is warning healthcare professionals and patients of a review of 14 bunches of ranitidine capsules appropriated by Sandoz Inc, the biosimilars and generics unit of Swiss pharma mammoth Novartis, used to decrease the amount of acids secreted by the stomach.
This review is because of a nitrosamine contamination, N-nitrosodimethylamine (NDMA), which was found in the reviewed drug. NDMA is named a plausible human cancer-causing agent.
“The FDA is committed to ensuring that the medicines Americans take are safe and effective. We began testing ranitidine products immediately after we learned of the potential impurity. When we identify lapses in the quality of drugs that pose potential risks for patients, the FDA makes all efforts to understand the issue and provide our best recommendation to the public as quickly and accurately as possible,” said Acting FDA Commissioner Dr Ned Sharpless, adding: “We will continue to investigate and work to ensure these types of impurities do not exceed acceptable limits, so that patients can continue taking the medicines they need without concern.”
Ranitidine is an over-the-counter (OTC) and physician recommended medication to deal with acidity. Ranitidine is a histamine-2 blocker. OTC ranitidine is affirmed to forestall and ease indigestion related with ingestion and sour stomach. Remedy ranitidine is approved for numerous signs, including treatment of ulcers of the stomach and digestion tracts and treatment of gastroesophageal reflux ailment.