Other safety alerts
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| China: CFDA announcement regarding revision of package insert of domperidone preparations |
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In Hong Kong, there are 47 registered pharmaceutical products containing domperidone, and are prescription only medicines. Related news regarding the risk of cardiac adverse reaction of domperidone was previously issued by various overseas drug regulatory authorities, and was posted on the Drug Office website since March 2012., with the latest update posted on 21 January 2015. Letters to inform local healthcare professionals were issued on 8 March 2012 and 10 March 2014.
In February 2012 and May 2014, the Registration Committee of the Pharmacy and Poisons Board (The Registrationn Committee) discussed the matter and made the following decision:
• To update the sales pack or package insert of domperidone-containing products to include the appropriate safety information related to cardiovascular risk.
• To tighten control over the sale oral domperidone products. In the past, the products were phamracy-only medicines. They are now classfified as prescription only medicines, and can only be sold with a prescription under the supervision of pharmacists.
The above are known adverse reactions and contraindications of domperidone, which have been documented in reputable overseas drug literatures such as "Martindale : The Complete Drug Reference". So far, the Department of Health (DH) has not received any adverse drug reaction report related to domperidone. DH will continue to monitor the safety update on domperidone by other overseas drug regulatory authorities, and take appropriate follow-up action when necessary.
Please refer to the following Chinese website for details:
http://www.drugoffice.gov.hk/eps/news/../26815.html
Ends/ Thursday, September 15, 2016
Issued at HKT 15:00
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