Other safety alerts
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| Zantac® [(Ranitidine hydrochloride Tablets) – Brown Discoloration] |
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GlaxoSmithKline Limited (GSK), a licensed drug wholesaler, informed the Department of Health (DH) about the possibility of brown discoloration present in some ranitidine tablets. GSK is going to issue letters to healthcare practitioners and investigators.
The information delivered by GSK is as follows:
Zantac® tablets are indicated for treating duodenal ulcer and benign gastric ulcer, including that associated with non-steroidal anti-inflammatory agents.
GSK would like to inform Healthcare Practitioners (HCPs) about the possibility of brown discoloration present in some ranitidine tablets. This discoloration may be present on the tablet surface or visible if a tablet is broken. Ranitidine tablets are marketed as Zantac®.
Ranitidine is known to degrade in the presence of moisture which results in a brown discoloration. The brown discoloration is due to impurities arising from the degradation of ranitidine. GSK has not been able to identify specific impurities resulting from the degradation in the brown-discoloured tablets, and are not able to confirm that the brown-discoloured tablets meet the product safety and quality standards. No safety issues arising from brown discoloured tablets have been identified and no adverse events attributable to the brown discoloured tablets have been reported to GSK.
The incidence of these reports of brown tablets is very low. If brown-discoloured tablets are found in current product supplies, they should not be consumed as the tablet may be ineffective. If a brown tablet is found it should be returned to GSK for further testing.
These brown discoloured tablets have occurred when there is a defect in the foil of the packaging blisters and have been reported as single tablets, i.e. the other tablets in the blister pack are normal white in appearance. It is essential tablets should not be removed from their packaging until they are to be taken. HCPs on receipt of brown tablets should return all blister packaged tablets including any samples to GSK.
As a precautionary measure, GSK is now undertaking a study to understand the specific impurities arising from the brown-discolouration so as to better assess product safety and quality standards. Product information (such as product leaflets) will also be updated to stress that the tablets should not be removed from their packaging until they are to be taken.
In Hong Kong, Zantac Tab 150mg (HK-42792) and 300mg (HK-42793) are pharmaceutical products registered by GSK. GSK is going to issue a "Dear Healthcare Professional Letter" to inform the healthcare professionals of the issue today. So far, the Department of Health (DH) has not received any adverse drug reaction case on the product. DH will maintain close contact with GSK to monitor any action deemed necessary and keep vigilant on any safety updates of the drug.
Ends/ Thursday, October 22, 2015
Issued at HKT 09:00
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