Medicine recalls
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| Australia: Azide impurity in 'sartan' blood pressure medicines |
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The Therapeutic Goods Administration (TGA) is investigating contamination of some 'sartan' medicines with unacceptable levels of an azide impurity, known as azidomethyl-biphenyl-tetrazole (AZBT). Sponsors of some sartan medicines have advised the TGA that very low levels of this impurity have been detected in batches of losartan and irbesartan products. The TGA is working with sponsors to investigate and ensure the issue is appropriately addressed.
In Australia, batches of losartan and irbesartan found to contain unacceptable levels of this azide impurity have been recalled from pharmacies. Details of the recalls are available in the TGA's System for Australian Recall Actions database. The affected products are:
- Link Pharmaceuticals: Losartan potassium 50mg Film Coated Tablets (batch number: 108885)
- Arrow Pharma Pty Ltd: AVSARTAN Irbesartan tablet 150mg and 300mg (batch number: BRBG019, IABG061, IACG042)
The impurity, known as azidomethyl-biphenyl-tetrazole (AZBT), is a compound that can form during the manufacture of the active ingredient in some sartan medicines. It is known to damage DNA, and as a result long-term exposure over years may increase an individual's risk of developing cancer. The risk posed by this azide impurity at the levels detected in sartan medicines to date is very low. However, such contamination is considered unacceptable for a medicine. The actual health risks from the impurity depend on the dose of the medicine and will vary from person to person.
Patients taking sartan medicines should not stop their treatment without first consulting a doctor or pharmacist. As the risks are very low, and associated with long-term exposure, there is no immediate health risk.
Health professionals may wish to remind patients of the importance of keeping their blood pressure under control and reassure them that that the risk posed by the impurity at the trace levels observed to date is very low.
Please refer to the following website in TGA for details:
http://www.tga.gov.au/alert/azide-impurity-sartan-blood-pressure-medicines
In Hong Kong, the above affected products are not registered pharmaceutical products.
Ends/Friday, Aug 20, 2021
Issued at HKT 15:00
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