NDA bans unsafe ulcer drug on market

NDA secretary. Mr David Nahamya

What you need to know:

Mandate. NDA is a government statutory body established to regulate human and veterinary medicines and other healthcare products.

The National Drug Authority (NDA), the regulatory drugs body, has warned the public against using Ranitidine, a drug used for treating ulcers and heartburn, saying it is not safe for humans.
Mr David Nahamya, the NDA secretary, said the drug contains high levels of a substance known as N-nitrosodimethylamine (NDMA) which is not safe for human consumption and is classified as a probable human carcinogen (a substance that could cause cancer).
“NDA has received reports from United States Food and Drug Authority that Ranitidine, a medicine prescribed for ulcers and heartburn, contains substance known as NDMA at high levels,” Dr Nahamya said yesterday.
He advised all those using the drug to contact their physicians for guidance on alternative treatment options.
Dr Nahamya also said NDA is working with all relevant stakeholders to ascertain the levels of NDMA in the Ranitidine on the market and shall take appropriate action based on their findings.
NDMA also known as dimethylnitrosamine, is a semi-volatile organic chemical, produced as by-product of several industrial processes and present at very low levels in certain foodstuffs, especially those cooked, smoked or cured.

About Ranitidine
According to online details, Ranitidine (also known by its brand name, Zantac, which is sold by the drug company Sanofi) is available both over the counter (OTC) and by prescription.
It belongs to the class of drugs known as H2 (or histamine-2) blockers. OTC ranitidine is commonly used to relieve and prevent heartburn.
Prescription strengths are also used to treat and prevent more serious ulcers in the stomach and intestines.
Multiple companies sell generic versions of both the OTC and prescription products.