Impurities in heartburn medication, Ranitidine causing cancer

What is Ranitidine?

Ranitidine is a drug that has been available since 1981 and was used to treat peptic ulcers at that time which was a drug that world desperately needed as 4 million people had peptic ulcers in the United States which resulted in 6000 deaths per year. However, in the modern age ranitidine is most commonly used to treat heartburn and indigestion as other medication such as proton pump inhibitors are more effective and so have replaced ranitidine. Ranitidine is sold in supermarkets and pharmacies under brand names commonly known as Zantac, Aciloc, Hyzan and many other names. On 13 September 2019 the US Food and Drug Administration(FDA) announced that tests on ranitidine found that the drug has been contaminated by N-nitrosodimethylamine(NDMA) and so the drug has been recalled in some countries.

What is NDMA?

NDMA is an environmental contaminant that people are exposed to in their everyday lives as it can be found in cooked and smoked meat, smoking cigarettes, beer, dairy products and vegetables. NDMA contamination is an issue because the World Health Organization has listed it as a probable carcinogen which means that it can cause cancer.  But it is important to note that NDMA does not pose an immediate health risk and that the classification of probable carcinogen is based on animal testing as human testing is limited. However, NDMA may cause cancer if taken in high doses over a long period of time.

How did this happen?

There are multiple possible reasons as to how the contamination occurred but the one of the most probable explanation would be that a chemical that is similar to NDMA, dimethylamine , that is used in the creation of ranitidine, and it may be possible that some NDMA was created when the drug was made. Another probable explanation is that ranitidine may be broken down producing NDMA during storage.

What is happening so far?

In most countries drugs related to ranitidine are being recalled by the manufacturers, so far in Australia, Apotex Ranitidine and Sandoz Ranitidine have been recalled but further recalls may occur. Australian Therapeutic Goods Administration is also working with international regulators and companies to investigate the problem and hopefully will solve it soon. The TGA also announced that they will be conducting batch testing on the drugs to determine the extent of the contamination in Australia.

What to do if you are taking ranitidine?

As international companies and corporations around the world continue to investigate and experiment on ranitidine, more details will be given, but for now ranitidine can still be used as ranitidine is only recommended for short-term usage. If you are currently using ranitidine for a long-term it would be wise to consult your physician on whether you still need ranitidine and if there might be alternative treatment options. As other medication that treat heartburn or indigestion from what we know does not have NDMA impurities.