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China: Announcement by China Food and Drug Administration (CFDA) on amendment of product insert of systemic fluoroquinolones (2017 Issue no. 79)
 
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
 
Related Information:
Australia: Update: fluoroquinolone antibiotics and adverse events Posted 2020-02-27
The United Kingdom: Fluoroquinolone antibiotics: new restrictions and precaution... Posted 2019-03-22
European Union : Disabling and potentially permanent side effects lead to suspen... Posted 2018-11-17
Fluoroquinolone and quinolone antibiotics: PRAC recommends restrictions on use (... Posted 2018-10-08
European Union: Fluoroquinolone and quinolone antibiotics: PRAC recommends restr... Posted 2018-10-06
European Union: European Medicines Agency (EMA) reviews persistence of side effe... Posted 2017-02-11
Canada: FLUOROQUINOLONES - Risk of disabling and persistent serious adverse reac... Posted 2017-01-24
The United States: FDA Drug Safety Communication: FDA updates warnings for oral ... Posted 2016-07-27
The United States: FDA Drug Safety Communication: FDA advises restricting fluoro... Posted 2016-05-13
Fluoroquinolones: restricting use for certain uncomplicated infections (Letter t... Posted 2016-05-13
 
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