Safety Information
Published: 6 March 2019
Revised: 21 October 2019
Monitoring
Losartan approved medicines supplied in New Zealand not affected by
recalls overseas
Losartan and valsartan update on potential for contamination with nitrosamines
Date 21 October 2019
This alert communication updates the monitoring communication.
Losartan approved medicines supplied in New Zealand not affected by recalls overseas published on 6 March 2019
Issue
Valsartan, losartan and irbesartan containing medicines have been recalled in some markets because they contain an impurity called N-nitrosodimethylamine (NDMA).
Medsafe has confirmed with the manufacturers that these medicines supplied in New Zealand are not produced by the method known to result in NMDA contamination. Further testing and verification of the quality of these medicines is now underway.
Advice for consumers and caregivers
Information for healthcare professionals
Products affected
Further information
Useful links
Advice for consumers and caregivers
Continue to take medicines containing losartan or valsartan. Products approved in New Zealand are not believed to be affected.
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
Losartan-Actavis tablets 12.5mg, 25mg, 50mg and 100mg, and Arrow-Losartan & Hydrochlorothiazide 50mg/12.5mg are the currently approved and PHARMAC funded medicines containing losartan in New Zealand.
Medsafe has been advised that the losartan used in the above medicines is not manufactured at the sites giving rise to the overseas recalls, and uses a different route of synthesis. In addition, the losartan active ingredient used in these medicines has been tested and no NDMA compounds have been found to be present.
Medsafe has also received confirmation that the approved valsartan containing combination medicines, Entresto 24/26, Entresto 49/51, and Entresto 97/103, also funded by PHARMAC, are not affected by this issue.
Any adverse events should be reported using the link below.
Products affected
Products affected by the actions taken by the European Medicines Agency include candesartan, ibersartan, losartan, olmesartan, valsartan (see link below). Currently no approved losartan or valsartan medicines in New Zealand are known to contain the impurity NDMA. Medsafe is working with sponsors to provide additional assurances that New Zealand product is not affected.
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.
Medsafe will publish updated information as it becomes available.
Useful Links
- Report an adverse reaction to a medicine
- Information published by the Therapeutic Goods Administration (TGA) in Australia
- Information published by the Food and Drug Administration (FDA) in the United States of America
- Information published by Health Canada (http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2019/70989a-eng.php)
