In Hong Kong, there are 194 registered pharmaceutical products which are systemic fluoroquinolones, including ciprofloxacin (83), levofloxacin (62), moxifloxacin (5), norfloxacin (8), ofloxacin (34), sparfloxacin (1) and prulifloxacin (1), all products are prescription-only medicines.
Drug safety news related to fluoroquinolones had previously been reported by overseas drug regulatory authorities, and posted on the Drug Office website since 8 Nov 2011, with the last update on 11 Feb 2017. Letters to inform local healthcare professionals on the above safety news had been issued in 2011, 2013 and 2016. In 2013, the Registration Committee of the Pharmacy and Poisons Board (the Registration Committee) discussed the safety of fluoroquinolones with peripheral neuropathy, and decided that the relevant warnings should be included in the sales packs and/or package inserts of the products. In 2016, the Registration Committee further discussed the safety of fluoroquinolones with disabling and potentially permanent side effects of the tendons, muscles, joints, nerves, and central nervous system, and subsequently decided to remain vigilant on further updates by other overseas drug regulatory authorities.
So far, the Department of Health (DH) has received 4 cases of adverse drug reaction related to levofloxacin, of which one case was related to tendinitis and neuropathy; the DH has not received any case of adverse drug reaction related to other fluoroquinolones. As the proposed warnings by the CFDA are similar to the previous safety news and warnings by the above health authorities, the DH will continue to remain vigilant on further safety updates by other overseas drug regulatory authorities.
Please refer to the following Chinese website for details:
http://www.drugoffice.gov.hk/eps/news/../28424.html
Ends/Thursday, Jul 6, 2017
Issued at HKT 17:00
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