Published: 23 September 2019

Safety Information

Alert

Medicines containing ranitidine and a potential impurity, N-nitrosodimethylamine (NDMA)

23 September 2019

Medicines containing ranitidine may contain an impurity called N-nitrosodimethylamine (NDMA). These medicines may be prescribed or can be purchased over the counter and are used for heartburn, gastric reflux or ulcers. Current information indicates that any impurity is at a low level.

Advice for consumers and caregivers
Information for healthcare professionals
Products affected
Further information
Useful links

Advice for consumers and caregivers

If you are taking ranitidine, you can continue to take this for short term use.

There is no known immediate health risk associated with this medicine. There is a very small possible risk that NDMA may cause cancer if taken long term.

If you are concerned discuss alternative treatment options with your pharmacist or doctor.

Medsafe cannot give advice about an individual’s medical condition. If you have any concerns about a medicine you are taking, you are encouraged to talk to your healthcare professional.

Information for healthcare professionals

NDMA is a potential carcinogen that is commonly found in some foods, water and air.

Acceptable levels of nitrosamines are based on safe levels if taken every day for 70 years. The levels of NDMA impurity detected in ranitidine to date, if taken over decades, may modestly increase the risk of developing cancer. It is not possible to provide an accurate estimate of the magnitude of carcinogenic risk associated with NDMA impurity based on currently available safety data.

If you have a patient who is worried about taking ranitidine, change them to an alternative treatment. The risks for patients taking low dose occasional ranitidine remain very low.

At the present time GlaxoSmithKline (NZ) Ltd has put a halt on all further supply of Zantac Injection 50mg/2mL until further information on the safety of this product is available.

Any adverse events should be reported using the link below.

Products affected

Due to the limited data currently available, all products containing ranitidine are potentially affected.

Products approved for supply in New Zealand containing ranitidine:

Product name Sponsor
Zantac solution for Inj GlaxoSmithKline (NZ) Limited
Zantac tablets 150mg Pharmacy Retailing (NZ) Ltd
Zantac tablets 300mg Pharmacy Retailing (NZ) Ltd
Peptisoothe syrup AFT Pharmaceuticals Ltd
Ranitidine Relief 150mg Mylan New Zealand Ltd
Ranitidine Relief 300mg Mylan New Zealand Ltd

Further information

NDMA is a type of N-nitroso compound. These compounds are commonly found in low levels in a variety of foods, particularly smoked and cured meats, as well as in some drinking water and in air pollution. Long term exposure, over years, may increase a person’s risk of developing cancer.

The presence of NDMA in some blood pressure medicines was identified in 2018 and is still being investigated globally. Link ( https://www.medsafe.govt.nz/safety/Alerts/Losartan.asp)

Medsafe is working with international regulators and the suppliers of these medicines to investigate the issue. At this stage these medicines are not being recalled, but this may change as further information becomes available.

Medsafe will publish updated information as it becomes available.

Useful links

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