Other safety alerts
|
| |
| Singapore: Restrictions on the use of metoclopramide-containing products |
| |
HSA, in consultation with its Medicines Advisory Committee, would like to update healthcare professionals on the restrictions on the use of metoclopramide-containing products, following concerns raised internationally on the relationship between the use of high doses or long-term use of metoclopramide and the increased risks of neurological adverse events, such as irreversible tardive dyskinesia.
HSA's benefit-risk assessment considered the current available scientific evidence, local adverse event reports and the input of local clinical experts. It was concluded that the benefit-risk profile of metoclopramide remains favourable for restricted indications in children and adults when administered within the recommended maximum daily doses and when treatment durations beyond 12 weeks are avoided.
Please refer to the following website in HSA for details:
http://www.hsa.gov.sg/content/hsa/../restrictions-on-theuseofmetoclopramidecontainingproducts.html
In Hong Kong, there are 33 registered pharmaceutical products containing metoclopramide. All products are prescription-only medicines. Related news has been released by the EMA, Singapore HSA, Health Canada, TGA and China FDA, and was posted on the Drug Office website on 27 July 2013, 24 July 2014, 6 January, 2 February and 25 April 2015 respectively. Letters to healthcare professionals were issued on 29 July 2013 to draw their attention to the warning. So far, the Department of Health (DH) has not received any adverse drug reaction case related to metoclopramide. The matter was discussed in the meeting of the Registration Committee of the Pharmacy and Poisons Board (the Committee) in September 2014. 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 DH will remain vigilant on the safety updates of the drug.
Ends/ Friday, July 24, 2015
Issued at HKT 15:00
|
| |
|
