On Friday, the US FDA (Food and Drug Administration) has announced a new concern about medicines used in heartburn. As per the federal agency, some ranitidine consists of low levels of an impurity that could lead to cancer. Ranitidine is a medicine which assists in treatment to reduce acid and treat heartburn. Notably, Zantac, a ranitidine tablet, includes carcinogenic agents. The investigation arrives after an online pharmacy company Valisure had notified of the FDA about the presence of NDMA in Zantac. Currently, the FDA is not recommending people to stop eating medicine. But patients using it, who wish to halt use, can contact their health experts before stopping the use.
Whereas, Zantac’s seller Sanofi notes patient safety is a severe concern for it, and they are committed to function with the FDA. As per the company, Zantac has a decade-long existence over the shelves. Even more, they follow all the defined safety needs for its use in the market. Various researches have marked NDMA or nitrosamine as a likely carcinogenic agent. Although it is not the first time that researchers have found NDMA in a common drug. From 2018, the FDA is probing NDMA, including other stains in the medicines of BP and heart failure treatments or ARB (Angiotensin Receptor Broker).
As a result of the analysis, the FDA has issued a recall to many of the drugs having unauthorized amounts of nitrosamines in various medicines containing valsartan. The study published in the medical journal BMJ reveals there is an increased short period overall risk of cancer among the people consuming valsartan drugs spoiled with NDMA. Apart from that, the study highlights a requirement trial accounting long-term cancer risk. Jeremy Kahn, an FDA spokesperson, said they are probing all products of ranitidine as well as testing additional samples. He notes until now they have discovered low amounts of NDMA in ranitidine. Currently, the executive does not have information regarding which companies’ products can have impurity. Jeremy said the FDA would publish more details as soon as it learns more during the analysis.