其 他 安 全 警 示
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| Singapore: Risk of hypomagnesaemia associated with long-term use of proton pump inhibitors (English Only) |
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HSA would like to inform healthcare professionals that emerging data has shown that proton pump inhibitors (PPIs) may cause hypomagnesaemia if taken for prolonged periods of time. This applies especially to treatment duration with PPIs that exceed one year. Low serum magnesium levels can result in serious adverse events including tetany, arrhythmias and convulsions. This risk may be increased for patients on concomitant drugs known to deplete magnesium, such as digoxin and diuretics. Patients who develop hypomagnesaemia, besides requiring magnesium supplementation, may also need to discontinue their PPI therapy. HSA recommends that healthcare professionals may consider monitoring magnesium levels prior to the initiation of PPI treatment and periodically in patients expected to be on prolonged PPI treatment or who take PPIs with medications such as digoxin or drugs that may cause hypomagnesaemia (eg, diuretics). Patients should be advised to seek immediate care from a healthcare professional if they experience arrhythmias, tetany, tremors, or seizures while on prolonged treatment.
Please refer to the following website in HSA for details:
http://www.hsa.gov.sg/publish/hsaportal/en/health_products_regulation/safety_information/product_safety_alerts/safety_alerts_2011.html
In Hong Kong, there are 140 proton pump inhibitor drugs registered. The ingredients include esomeprazole, lansoprazole, omeprazole, pantoprazole and rabeprazole. All these products are prescription-only medicines except the products containing omeprazole. The safety issue was released by the US FDA and was posted on the website of Pharmaceutical Service on 3 March 2011. A letter to inform healthcare professionals and press release were issued on the same day. The matter has been discussed in the meeting of the Registration Committee of the Pharmacy and Poisons Board on 11 May 2011 and the Board has issued letters to inform certificate holders about the appropriate warnings required for all products containing proton pump inhibitors.
Ends/ Tuesday, August 23, 2011
Issued at HKT 17:00
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