Health Sciences Authority (HSA) announces that eight brands of ranitidine medicines have been found to contain trace amounts of a nitrosamine impurity, N-nitrosodimethylamine (NDMA), which are above the internationally acceptable level. As a precautionary measure, HSA is stopping the sale and supply of the affected ranitidine medicines at clinics, hospitals and pharmacies. The affected products are:
- Aciloc 150 Tablet 150 mg, Aciloc 300 Tablet 300 mg
- Apo-Ranitidine Tablet 150 mg
- Hyzan Tablet 150 mg
- Neoceptin R-150 Tablet 150 mg
- Vesyca Film Coated Tablet 150 mg
- Xanidine Tablet 150 mg
- Zantac Injection 25 mg/ml, Zantac Syrup 150 mg/10 ml, Zantac Tablet 150 mg
- Zynol-150 Tablet 150 mg
The potential risk of nitrosamines is associated with long term exposure, and patients who have been prescribed with the affected ranitidine medicine for short term use may continue with their medicine. Patients who have any questions about their current treatment can speak to their doctor or pharmacist. There are several other medicines that can be used as alternatives to manage the same conditions.
HSA has tested all locally marketed brands of ranitidine and found trace amounts of the NDMA nitrosamine, that exceeded the internationally acceptable level, in eight brands. Acceptable levels of nitrosamines are set in nanograms (ng), i.e., one billionth of a gram, and is based on what is considered as reasonably safe if a patient continues to take the affected medicine every day for a lifetime of 70 years.
In line with the stringent standards set by HSA on the quality of medicines in Singapore, HSA has directed the companies to stop the sale and supply of the affected brands of ranitidine medicines at clinics, hospitals and pharmacies. HSA is also working with the companies supplying these medicines and international regulatory agencies to verify the causes of the contamination, and to identify the necessary measures to address the issue.
Please refer to the following website in HSA for details:
http://www.hsa.gov.sg/content/hsa/../HSA-stops-supply8brandsRanitidine.html
In Hong Kong, the following 5 brands (10 products) are registered pharmaceutical products:
- Apo-Ranitidine Tab 150mg (HK-42273), Apo-Ranitidine Tab 300mg (HK-41873)
- Hyzan Tab 150mg (HK-44437)
- Vesyca F.C. Tab 150mg (HK-36650)
- Zantac Inj 25mg/ml (HK-42045), Zantac Syrup 150mg/10ml (HK-30459), Zantac Tab 75mg (HK-41114), Zantac Tab 150mg (HK-42792), Zantac Tab 300mg (HK-42793)
- Zynol-150 Tab 150mg (HK-59695)
The Department of Health (DH) is currently contacting the certificate holder of these registered ranitidine products for follow up on the local impact of the issue.
Currently, there are 67 registered pharmaceutical products containing ranitidine in Hong Kong. These products in the forms of oral preparations and injections are controlled as over-the-counter medicines and prescription-only medicines respectively. So far, DH has not received any case of adverse drug reaction related to ranitidine.
Related news on the detection of NDMA in ranitidine products was previously issued by European Medicines Agency, the US Food and Drug Administration and Health Canada, and was posted on the Drug Office website on 16 Sep 2019. The DH has contacted the relevant overseas drug regulatory authorities for further information regarding the detection of NDMA in ranitidine products. Their replies are pending. The DH is currently contacting the certificate holder of all registered ranitidine products for follow up on the local impact of the issue. The DH will remain vigilant on the development of the issue and any safety update of the drug issued by overseas drug regulatory authorities for consideration of any action deemed necessary.
Patients who are taking ranitidine-containing products should not stop taking the medicines, but should seek advice from their healthcare professionals for proper arrangement, e.g. use of alternative medicines with similar uses.
Ends/Tuesday, Sep 17, 2019
Issued at HKT 15:00
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