Medicine recalls
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| Canada: Multiple lots of irbesartan, losartan and valsartan drugs recalled due to azido impurity |
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Health Canada announces that several companies (Pro Doc Ltd, Sivem Pharmaceuticals ULC, Mint Pharmaceuticals Inc, Pharmascience Inc, Sun Pharma Canada Inc, Sandoz Canada Inc, Auro Pharma Inc, Teva Canada Ltd and Sanis Health Inc) are recalling multiple lots (226 lots) of irbesartan, losartan and valsartan drug products after tests found an azido impurity above the acceptable limit. For details of the affected products and lot numbers, please refer to the website in Health Canada.
Irbesartan, losartan and valsartan are all prescription angiotensin receptor blocker (ARB) drugs, which are also known as "sartans." Sartans are a class of drugs used to treat patients with high blood pressure to help prevent heart attacks and stroke. They are also used in patients with heart failure or those who have had a recent heart attack.
The azido impurity, (5-(4'-(azidomethyl)-[1,1'-biphenyl]-2yl)-1H-tetrazole, is considered a mutagen. A mutagen is a chemical substance that can cause a change in the DNA of a cell. These mutations may increase the risk of cancer but the specific risk for this azido impurity to cause cancer in humans is unknown.
There are established international guidelines that recommend that mutagenic impurities be kept at or below a specific level because exposure to a mutagen over the long term at a level above what is considered to be safe, has the potential to increase the risk of cancer. A person taking a drug daily for 70 years that contains this azido impurity at or below the acceptable level is not expected to have an increased risk of cancer.
Not all lots of irbesartan, losartan and valsartan from these companies are affected by this issue; however, it is possible that the recalls may affect the supply of some products. Patients should speak with their doctor or pharmacist to discuss alternatives should their regular prescribed drug not be available.
The Department expects manufacturers to take any necessary actions to reduce or eliminate the azido impurity. Impacted companies have been directed to implement control measures to ensure that the level of the impurity in their products are at or below the acceptable level. Health Canada is monitoring the effectiveness of the recalls. Should additional recalls be deemed necessary, Health Canada will inform Canadians.
Please refer to the following website in Health Canada for details:
http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/../75715a-eng.php
In Hong Kong, the following sartan-containing products are prescription-only medicines, and are registered by:
Trenton-boma Ltd (T-boma):
- PMS-Irbesartan Tab 150mg (HK-61098)
- PMS-Irbesartan Tab 75mg (HK-61099)
- PMS-Irbesartan-HCTZ Tab 300mg/12.5mg (HK-61320)
- PMS-Irbesartan-HCTZ Tab 300mg/25mg (HK-61318)
As confirmed with T-boma, PMS-Irbesartan Tab 150mg (HK-61098; lot 617492) has been imported into Hong Kong.
Novartis Pharmaceuticals (HK) Limited (Novartis)
- Irbesartan Sandoz Tab 150mg (HK-61104)
- Irbesartan Sandoz Tab 300mg (HK-61105)
- Irbesartan HCT Sandoz Tab 150mg/12.5mg (HK-61525)
- Irbesartan HCT Sandoz Tab 300mg/12.5mg (HK-61534)
- Irbesartan HCT Sandoz Film-Coated Tablets 300mg/25mg (HK-61164)
As confirmed with Novartis, the affected lots have not been imported in Hong Kong.
Teva Pharmaceutical Hong Kong (Teva)
- Losartan-Teva Film-Coated Tablets 100mg (HK-63284)
- Losartan-Teva Tab 50mg (HK-58863)
As confirmed with Teva, the affected lots have not been imported in Hong Kong.
There is no registered pharmaceutical product containing irbesartan, losartan and valsartan manufactured by Pro Doc Ltd, Sivem Pharmaceuticals ULC, Mint Pharmaceuticals Inc, Sun Pharma Canada Inc, Auro Pharma Inc and Sanis Health Inc.
On 31 May 2021, the Department of Health (DH) endorsed T-boma to recall PMS-Irbesartan Tab 150mg (HK-61098; lot: 617492) and PMS-Irbesartan Tab 300mg (HK-61097; lot: 624193) from the market as a precautionary measure due to the presence of an impurity in the products. A press statement was issued on the same date. The DH will continue to monitor the recall.
Ends/Monday, May 31, 2021
Issued at HKT 21:35
Content last updated on Tuesday, Jun 1, 2021
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