NDMA impurity found in ranitidine – what are the alternatives?

Drug authorities overseas have reportedly found an impurity called N?nitrosodimethylamine (NDMA) in some samples of ranitidine, a medication used to treat ulcers and gastroesophageal reflux disease (GERD) caused by stomach acid.

Australia’s Therapeutic Goods Administration (TGA) is currently working with international regulators to investigate the issue and is testing batches of Australian ranitidine to determine if further action needs to be taken in this country.

Ranitidine, which is marketed in Australia under the brand name Zantac, is a prescription medication, however it can also be purchased over the counter from pharmacies and some supermarkets.

NDMA is a N-nitroso compound commonly found in low levels in smoked and cured meats as well as in some drinking water and in air pollution. According to the TGA, “Long-term exposure, over years, can increase an individual’s risk of developing cancer.”

The TGA says, “The additional risk posed by NDMA from ranitidine, at the levels identified to date, is considered to be very low. However, such contamination is considered unacceptable for a medicine. The actual health risks depend on dose and will vary from person to person. The risks from short-term use of ranitidine are expected to be extremely low.”

“The levels of NDMA contamination detected in ranitidine to date, if taken over decades, may modestly increase an individual’s risk of developing cancer.”

The TGA says that, while there is no immediate health risk associated with this medication, if concerned, “…doctors who are treating a patient with ranitidine should consider alternative management where clinically appropriate, which may include an alternate H₂ receptor antagonist, proton-pump inhibitors, and/or diet and lifestyle modification.

National Custom Compounding can make up alternatives to ranitidine, such as proton-pump inhibitors, that do not have the risk of containing NDMA. For more information contact National Custom Compounding on 1300 731 755 or email [email protected]. In many cases we can turn around a prescription in as little as 24 hours.