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Pharmaceutical Companies Recall Ranitidine Medications Due to Cancer-Causing Agent

October 03, 2019

Pharmaphorum reported that Ranitidine-based drugs had been recalled globally due to the presence of a potential cancer-causing agent in the drug. The suspected carcinogen is a nitrosamine impurity known as N-nitrosodimethylamine or NDMA for short. The U.S. Food and Drug Administration said that it observed the presence of the impurity at low levels in various medicines including Ranitidine. Ranitidine is a drug designed to combat stomach problems like heartburn, acid reflux, sour stomach, and ulcers. Some Ranitidine products are sold over the counter as Zantac or marketed by retailers like Walmart, Walgreens, and Rite Aid as a Ranitidine medication. So far, there are no reports of cancer diagnosis caused by NDMA or as a result of taking Ranitidine-based products. *

The FDA has had Ranitidine products and losartan products under investigation since 2018 after it found NDMA present in angiotensin II receptor blockers. Angiotensin II receptor blockers are used to combat high blood pressure and other heart-related ailments in certain patients. 

European health agencies have kept a watchful eye over the effects of NDMA as well. Accordingly, Dr. Reddy’s and GlaxoSmithKline have recalled its prescriptions containing Ranitidine. Additionally, Strides Pharma, based in India, has also announced a recall of Ranitidine products. 

The FDA, despite its lengthy investigation into the potential cancer-causing effectors of NDMA, said that it is not recommending that every company selling Ranitidine products issue a recall. Additionally, the FDA does not recommend patients stop taking their prescribed medications even if there is a threat of the presence of NDMA. 

The most widely known product which is Ranitidine-based is Zantac. The generic form of Zantac sold by pharmaceutical retailers Walgreens, Rite Aid, and Walmart all are subject to recall at this time. Apotex manufactures Ranitidine under the store names for the three retailers. Sandoz has recalled its prescription-only version of Ranitidine in the U.S. in conjunction with the FDA.

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Category: Product Liability

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