Print Page

Other safety alerts

The United States: FDA Drug Safety Communication: FDA advises restricting fluoroquinolone antibiotic use for certain uncomplicated infections; warns about disabling side effects that can occur together
The U.S. Food and Drug Administration (FDA) is advising that the serious side effects associated with fluoroquinolone antibacterial drugs generally outweigh the benefits for patients with sinusitis, bronchitis, and uncomplicated urinary tract infections who have other treatment options. For patients with these conditions, fluoroquinolone should be reserved for those who do not have alternative treatment options.

An FDA safety review has shown that fluoroquinolones when used systemically (i.e. tablets, capsules, and injectable) are associated with disabling and potentially permanent serious side effects that can occur together. These side effects can involve the tendons, muscles, joints, nerves, and central nervous system.

As a result, FDA is requiring the drug labels and Medication Guides for all fluoroquinolone antibacterial drugs to be updated to reflect this new safety information. Currently available FDA-approved fluoroquinolone antibacterial drugs for systemic use include moxifloxacin, ciprofloxacin, gemifloxacin, levofloxacin and ofloxacin. FDA is continuing to investigate safety issues with fluoroquinolones and will update the public with additional information if it becomes available.

Patients should contact their health care professional immediately if you experience any serious side effects while taking your fluoroquinolone medicine. Some signs and symptoms of serious side effects include tendon, joint and muscle pain, a “pins and needles” tingling or pricking sensation, confusion, and hallucinations.

Health care professionals should stop systemic fluoroquinolone treatment immediately if a patient reports serious side effects, and switch to a non-fluoroquinolone antibacterial drug to complete the patient’s treatment course.

Please refer to the following website in FDA for details:

In Hong Kong, there are 248 registered pharmaceutical products which are fluoroquinolone antibacterial drugs, including 106 ciprofloxacin products, 66 levofloxacin products, 52 ofloxacin products, 9 moxifloxacin products, 11 norfloxacin products, 2 lomefloxacin products, 1 prulifloxacin product and 1 sparfloxacin product. All these products are prescription only medicines. So far, the Department of Health has received one adverse drug reaction case (ADR) in connection with levofloxacin, but it was not related to the serious side effects mentioned in the above announcement. No ADR case has been received for the other fluoroquinolone drugs. In view of the FDA announcement, letters to local healthcare professionals to draw their attention will be issued, and the matter will be discussed by the Registration Committee of the Pharmacy and Poisons Board.

Ends/ Friday, May 13, 2016
Issued at HKT 15:00
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
China: Announcement by China Food and Drug Administration (CFDA) on amendment of... Posted 2017-07-06
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
Fluoroquinolones: restricting use for certain uncomplicated infections (Letter t... Posted 2016-05-13