KAMPALA – The National Drug Authority (NDA) has warned against continued buying and prescription of Ranitidine, a medicine prescribed for ulcers and heartburn, saying it has been found to be a cancer-causing agent.
In a statement issued on Monday, October 21, 2019, the NDA Secretary, Dr David Nahamya, said it has received reports from the United States Food and Drug Authority that Ranitidine contains a substance known as N-nitrosodimethylamine (NDMA) at high levels.
“N-nitrosodimethylamine at high levels is not safe for human consumption and is classified as a probable human carcinogen. If you are using Ranitidine, you are advised to contact your prescriber for further guidance on other treatment options,” the statement read in part.
“NDA is working with all the relevant stakeholders to ascertain the levels of NDMA in the Ranitidine on the market and shall take appropriate action based on the results obtained. NDA is committed to ensuring that Ugandans receive safe, effective and quality medicines and health care products,” the statement adds.
The US Food and Drug Authority (FDA) said the drug, which goes by the brand name Zantac, contains nitrosamine.
FDA said it had been investigating NDMA and other nitrosamine-related impurities in blood pressure and heart failure medicines known as Angiotensin II Receptor Blockers(ARB) since 2018. “In the case of ARBs, the FDA has recommended numerous recalls as it discovered unacceptable levels of nitrosamines,” said FDA.