Safety Information

Alert

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

Updated 21 October 2019. Original communication published 23 September 2019

This alert communication has been updated and replaces the original alert. The availability of ranitidine medicines in New Zealand is now extremely limited. Healthcare professionals should consider other therapeutic alternatives.

Issue

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 commonly used for heartburn, gastric reflux or ulcers. Current information indicates that any impurity is at a low level. Suppliers of these medicines are testing them to determine the level of impurity.

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

Advice for consumers and caregivers

If you are taking a medicine containing ranitidine, you can continue to take this for short term use. If you have been prescribed ranitidine, you can continue to take the medicine that has been dispensed to you by your pharmacist. If you take this medicine long term, you should see your healthcare professional to discuss possible alternatives.

There is no known immediate health risk associated with this medicine. There is a very small 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

The availability of ranitidine containing medicines in New Zealand (and globally) is now extremely limited. See the table below for the products affected and their current status. Healthcare professionals who wish to know what alternate products are funded should contact consult the Hospital and Community Pharmaceutical Schedule.

https://schedule.pharmac.govt.nz/ScheduleOnline.php

Any adverse events should be reported using the link below.

Products affected

*indicates product is PHARMAC funded

Product name	Sponsor / Supplier	Status
Zantac solution for Inj*	GlaxoSmithKline (NZ) Limited	Recalled to pharmacy level. Healthcare professionals who wish to discuss access to this product for oncology and palliative care patients should contact the sponsor, 0800 877 789.
Zantac tablets 150mg	Pharmacy Retailing (NZ) Ltd	Recalled to pharmacy level.
Zantac tablets 300mg	Pharmacy Retailing (NZ) Ltd	Recalled to pharmacy level.
Peptisoothe syrup*	AFT Pharmaceuticals Ltd	Supply to the market on hold.
Ranitidine Relief 150mg*	Mylan New Zealand Ltd	Recalled to pharmacy level.
Ranitidine Relief 300mg*	Mylan New Zealand Ltd	Recalled to pharmacy level.

Further information

NDMA is a type of nitrosamine 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. It is not possible to provide an accurate estimate of the level of risk associated with NDMA impurity based on currently available safety data.

The EMA issued recommendations to manufacturers in April and September 2019 as a result of an ongoing review of nitrosamine impurities in medicines. More information relating to this is published at the monitoring communication below.

Losartan approved medicines supplied in New Zealand not affected by recalls overseas

This alert will be updated when further information is available.