Published: 21 October 2019
Safety Information
Monitoring
Review of chemically synthesised active pharmaceutical ingredients for presence of nitrosamine impurity
21 October 2019
Issue
The identification of impurities in some medicines containing losartan, valsartan and ranitidine has indicated a need to check all medicines for the presence of nitrosamines.
The European Medicines Agency has advised companies on steps to take to avoid nitrosamines in human medicines. Companies supplying medicines to the EU have been instructed to review their medicines for the possible presence of nitrosamines and test all products at risk.
Products affected by this notice are medicines containing a chemically synthesised active substance. A number of these medicines, and other medicines which would potentially be affected, are also supplied to New Zealand. Medsafe understands this notice to be a precautionary measure, to further manage a very small risk related to these medicines and will be requesting that companies supplying medicines in New Zealand also review their medicines.
Advice for consumers and caregivers
Information for healthcare professionals
Products affected
Further information
Useful links
Advice for consumers and caregivers
There is no need to make any changes to the medicines you take. Medsafe will issue further advice on individual medicines if necessary.
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
Medsafe emphasises that the measures taken by the EMA are precautionary, to further manage a small risk related to these medicines. This is reflected in the time the EMA has allowed companies to comply: three years.
Should any further quality issues with medicines supplied in New Zealand be identified Medsafe will issue further advice.
Products affected
Products affected by this issue are medicines containing a chemically synthesised active substance. This includes a large number of medicines available in New Zealand.
To date, Medsafe has published information with regard to the following products:
Medicines containing losartan, valsartan, candesartan,
ibersartan, and olmesartan:
Refer to our monitoring communication:
https://www.medsafe.govt.nz/safety/Alerts/Losartan.asp
Medicines containing ranitidine:
Refer to our monitoring communication:
https://www.medsafe.govt.nz/safety/Alerts/MedicinesAndNDMA.asp
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.
There is no known immediate health risk associated with this medicine as the risks related to NDMA are associated with high doses and long term use.
Medsafe is working with international regulators and the suppliers of these medicines to investigate the issue. As further medicines are evaluated and tested for presence of NDMA, it is possible that further products will be removed from the market. Medsafe will publish updated information as it becomes available.
We continue to monitor the situation, and actions taken by overseas regulators.
Useful links
