HSA Updates on Overseas Recall of Angiotensin II Receptor Blockers
In recent months, several overseas regulatory agencies have conducted recalls of certain products belonging to a class of medicines known as angiotensin II receptor blockers (ARBs) due to the detection of N-nitrosodimethylamine (NDMA) and N-Nitrosodiethylamine (NDEA).
2 The ARB class of medicines is used for the control of high blood pressure and include valsartan, losartan, candesartan, fimasartan, irbesartan and olmesartan. The recalls were conducted as the affected ARBs contained unacceptable levels of these impurities. Studies conducted in animals have shown that prolonged consumption of these impurities may increase the occurrence of cancer.
Local situation
3 To safeguard public health, the Health Sciences Authority (HSA) has been testing the ARBs marketed in Singapore for the presence of NDMA and NDEA. To-date, none of the marketed ARBs that were tested by HSA has been detected to contain unacceptable levels of NDMA or NDEA. Hence, Singapore is not affected by the product recalls overseas.
4 While the ARB medicines that are available in Singapore are not affected, HSA will continue to monitor the local situation and update the public if there are any new findings.
Patient advisory
5 Patients should continue to take their ARB medicines unless otherwise advised by their doctors.ARBs are used for the treatment of high blood pressure. If untreated, it may lead to heart attacks and stroke.
HEALTH SCIENCES AUTHORITY
SINGAPORE
19 DECEMBER 2018
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HSA Updates