Other safety alerts
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| Singapore: Amendments to the Dear Healthcare Professional Letter dated 23 July 2015 on "Restrictions on the use of metoclopramide-containing products" |
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Singapore Health Sciences Authority (HSA) announced that HSA would like to update healthcare professionals on the amendments to the restrictions on the use of metoclopramide-containing products based on further feedback received.
HSA has reviewed the feedback and amended the indication and the duration of use, and the recommended maximum daily dose of the drug. Indications for use in children have been restricted to the second-line treatment of established post-operative nausea and vomiting (only via the intravenous route), with the maximum daily dose of 0.5 mg/kg. For all indications in both adults and children, treatment should be kept as short as possible, in accordance to one’s clinical judgement. It has also been clarified that as adverse events increased with dose, the dose should be restricted to the minimum effective dose, which is in line with the European Medicines Agency’s recommendation.
Please refer to the following website in HSA for details:
http://www.hsa.gov.sg/content/hsa/../amendments-to-thedearhealthcareprofessionalletterdated23july2015.html
In Hong Kong, there are 34 registered pharmaceutical products containing metoclopramide, and are prescription only medicines. Related news was previously issued by various overseas drug regulatory authorities, and was posted on the Drug Office website since July 2013, and the latest update was posted on 24 July 2015. Letters to inform local healthcare professionals were issued on 29 July 2013. So far, The Department of Health has not received any adverse drug reaction case related to metoclopramide. In September 2014, the Registration Committee of the Pharmacy and Poisons Board (the Committee) decided that the sales pack label and/or package insert of metoclopramide-containing products should be updated to include the appropriate safety information. The HSA's update is based on EMA's recommendation which has already been discussed by the Committee.
Ends/ Tuesday, March 29, 2016
Issued at HKT 15:00
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