ADR that result in revision of patient information
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| Singapore: Update to the Primperan (metoclopramide) package insert for Singapore - Updated indications and posology to minimise risk of adverse effects (particularly neurological effects) |
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Sanofi-aventis Singapore Pte. Ltd. would like to inform healthcare professionals of the safety updates to the local package inserts for Primperan Injection 10 mg/2 ml and Tablet 10 mg to minimise the risks of neurological and other dose-related adverse reactions. Metoclopramide should only be prescribed for short-term use at recommended doses and dose-intervals. Intravenous doses should be administered as a slow bolus. Use in adults are restricted to short-term prevention and treatment of nausea and vomiting, including that associated with chemotherapy, radiotherapy, surgery and migraine. Children less than 1 year of age are contraindicated from use due to the risk of neurological reactions and methaemoglobinaemia. In children aged 1-18 years, metoclopramide is restricted as a second option for treatment of established post-operative nausea and vomiting (for intravenous route only) and prevention of chemotherapy-induced nausea and vomiting.
Please refer to the following website in HSA for details:
http://www.hsa.gov.sg/publish/hsaportal/../DHCPL.html
In Hong Kong, there are 32 registered pharmaceutical products containing metoclopramide and they are registered by 24 companies, including Primperan Inj 10mg/2ml (HK-07173) and Primperan Tab 10mg (HK-07177) registered by Sanofi-aventis Hong Kong Limited. All these products are prescription-only medicines. Related news was released by European Medicines Agency (EMA) and posted on the Drug Office website on 27 July 2013. Letters were issued to healthcare professionals on the EMA announcement and to the 24 companies to update their package inserts with the new warnings on 29 July 2013 and 31 July 2013 respectively. So far, the Department of Health has not received any local adverse drug reaction report related to these products. In view of the above EMA and HSA announcements, the matter will be discussed in the meeting of the Registration Committee of the Pharmacy and Poisons Board.
Ends/ Thursday, July 24, 2014
Issued at HKT 15:00
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