Other safety alerts
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| Singapore: Transdermal Durogesic (fentanyl): Reminder on the potential for life-threatening harm from accidental exposure to transdermal fentanyl |
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Janssen, a division of Johnson & Johnson Pte Ltd, would like to alert healthcare professionals to the potential risk of accidental exposure to transdermal Durogesic patches. The issue of accidental exposure is not a new safety issue. However, cases of accidental exposure to transdermal Durogesic in non-patch wearers, leading to fatal outcomes especially in children, continue to be reported overseas. To prevent potential life-threatening harm from accidental exposure to Durogesic patches, healthcare professionals are reminded of the importance to provide clear information to patients and caregivers regarding risk of accidental patch transfer, accidental ingestion of patches by children, and need for appropriate disposal of used patches.
Please refer to the following website in HSA for details:
http://www.hsa.gov.sg/publish/hsaportal/../DHCPL.html
In Hong Kong, there are six registered pharmaceutical products containing fentanyl transdermal patches, namely Durogesic Transdermal Patch 50mcg/h (HK-53753), Durogesic Transdermal Patch 100mcg/h (HK-53754), Durogesic Transdermal Patch 25mcg/h (HK53755), Durogesic Transdermal Patch 12mcg/h (HK-53883), Fentanyl HPQ Transdermal Patch 50mcg/h (HK-59083), and Fentanyl HPQ Transdermal Patch 25mcg/h (HK-59084). All the products are prescription-only medicines. Related news had been released by the US FDA and Health Canada, and posted on the Drug Office website on 20 April 2012, 24 September 2013 and 12 October 2013. Letters to inform healthcare professionals on similar safety concerns as the above announcement had also been issued on 20 April 2012. So far, the Department of Health (DH) has not received any local adverse drug reaction report related to these products. The package inserts of all the 4 Durogesic and 2 Fentanyl HPQ products contain warning information on folding the patches with adhesive sides inward before disposal similar to the HSA announcement. The DH will keep vigilant on any further safety update related to fentanyl transdermal patches by other drug regulatory authorities.
Ends/ Friday, July 04, 2014
Issued at HKT 15:00
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