Medicine recalls
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| Singapore: HSA updates on the phasing-out of lysozyme-containing products as therapeutic products |
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The Health Sciences Authority (HSA) has conducted a re-evaluation of the benefit-risk profile of lysozyme and concluded that it has failed to show efficacy. As such, HSA will be phasing out the use of lysozyme in therapeutic products in Singapore. Currently, lysozyme-containing products are approved as an expectorant and mucolytic for chronic sinusitis, as well as treatment for bleeding.
The re-evaluation was undertaken following the voluntary cancellation of the product Neuzym by the registrant (Eisai) in March 2016, due to the failure of recent post-marketing studies to show statistical significant differences in the efficacy of lysozyme compared to placebo. HSA concluded likewise that evidence from the post-market clinical studies as well as published literature to date had failed to show efficacy of lysozyme. While lysozyme has a long history of use in Singapore since 1989 with no significant safety concern, the lack of efficacy rendered its use as a therapeutic product unjustifiable. Nonetheless, the lack of efficacy for therapeutic use does not preclude the use of lysozyme in other categories of health products such as health supplements.
Therefore, lysozyme-containing products will be de-registered as therapeutic products in Singapore. Considering the long history of use of lysozyme in Singapore and the acceptable safety profile, currently registered lysozyme-containing products will be allowed a grace period until 31 December 2018, before the products are removed from the Register of Therapeutic Products.
Please refer to the following website in HSA for details:
http://www.hsa.gov.sg/content/hsa/../lysozymecontainingproducts.html
In Hong Kong, there are 257 registered pharmaceutical products containing lysozyme, including 51 single-ingredient products and 206 multiple-ingredient products. So far, the Department of Health (DH) has not received any case of adverse drug reaction related to lysozyme. The matter will be discussed by the Registration Committee of the Pharmacy and Poisons Board.
Ends/Wednesday, Jun 28, 2017
Issued at HKT 15:00
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