藥物警訊

Fluoroquinolone Antibacterial Drugs for Systemic Use: Drug Safety Communication - Warnings Updated Due to Disabling Side Effects

Including the following currently available fluoroquinolones

Avelox (moxifloxacin)、Cipro (ciprofloxacin)、Cipro extended-release (ciprofloxacin extended-release)、Factive (gemifloxacin)、Levaquin (levofloxacin)、Ofloxacin (generic brand)

AUDIENCE: Family Practice, Infectious Disease, Neurology, Pharmacy, Patient

ISSUE: FDA approved changes to the labels of fluoroquinolone antibacterial drugs for systemic use (i.e., taken by mouth or by injection). These medicines are associated with disabling and potentially permanent side effects of the tendons, muscles, joints, nerves, and central nervous system that can occur together in the same patient. As a result, FDA revised the Boxed Warning, FDA's strongest warning, to address these serious safety issues. In addition, FDA updated other parts of the drug label including the Warnings and Precautions and Medication Guide sections.

FDA has determined that fluoroquinolones should be reserved for use in patients who have no other treatment options for acute bacterial sinusitis, acute exacerbation of chronic bronchitis, and uncomplicated urinary tract infections because the risk of these serious side effects generally outweighs the benefits in these patients. For some serious bacterial infections the benefits of fluoroquinolones outweigh the risks, and it is appropriate for them to remain available as a therapeutic option.

FDA is continuing to assess safety issues with fluoroquinolones as part of FDA's usual ongoing review of drugs and will update the public if additional actions are needed. See the FDA Drug Safety Communication for additional information, including a Data Summary and Additional Information for Health Care Professionals and Patients.

BACKGROUND: The labels of fluoroquinolone medicines already have a Boxed Warning for tendinitis, tendon rupture, and worsening of myasthenia gravis. The labels also include warnings about the risks of peripheral neuropathy and central nervous system effects. Other serious risks associated with fluoroquinolones are described in the labels, such as cardiac, dermatologic, and hypersensitivity reactions. After FDA's 2013 review that led to the additional warning that peripheral neuropathy may be irreversible, FDA evaluated post-marketing reports of apparently healthy patients who experienced disabling and potentially permanent side effects involving two or more body systems after being treated with a systemic fluoroquinolone

RECOMMENDATION: Patients must contact your 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 unusual joint or tendon pain, muscle weakness, a “pins and needles” tingling or pricking sensation, numbness in the arms or legs, confusion, and hallucinations. Talk with your health care professional if you have any questions or concerns (see List of Serious Side Effects from Fluoroquinolones in the FDA Drug Safety Communication).

Health care professionals should not prescribe systemic fluoroquinolones to patients who have other treatment options for acute bacterial sinusitis (ABS), acute bacterial exacerbation of chronic bronchitis (ABECB), and uncomplicated urinary tract infections (UTI) because the risks outweigh the benefits in these patients. Stop 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.

Read the MedWatch safety alert, including a link to the FDA Drug Safety Communication, at:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHuma...

美國FDA更新口服及注射劑型之fluoroquinolone類抗細菌感染製劑仿單之加框警語內容，新增此類藥品可能發生肌腱炎、肌腱斷裂、惡化重症肌無力，周邊神經病變及影響中樞系統等永久性傷害，且2013年美國FDA於回顧性評估中更認為周邊神經病變可能無法復原。這些嚴重副作用可能同時於不同部位發生，美國FDA已著手進行病人使用後發生兩個部位以上之傷害的上市後通報案例評估。而其他與fluoroquinolone相關之不良反應，如心律、皮膚或過敏反應也已註明於藥品仿單之中。除此之外，也同步更新於警語及注意事項和病人用藥教育之欄位中，提醒病人注意。

美國FDA認為，fluoroquinolone類抗細菌感染製劑應保留予對其他治療無效之急性細菌性鼻竇炎、慢性支氣管炎之急性發作或非複雜性尿道感染。對於部分嚴重之細菌感染，若經評估其使用fluoroquinolone類抗細菌感染製劑之利大於弊，才建議做為治療的選擇之一。美國FDA將持續評估此安全性問題是否需進一步處置。

目前正在使用此類藥品之病人，若出現不尋常的關節或肌腱疼痛、肌肉無力，四肢刺痛或麻痺感，意識模糊或混沌等疑似嚴重副作用的症狀，應立即就醫；而醫療人員對於尚有其它藥品可選擇之急性細菌性鼻竇炎、慢性支氣管炎之急性發作或非複雜性尿道感染病人，應優先使用非fluoroquinolone類抗細菌感染製劑治療。若病人在使用fluoroquinolone類藥品治療中發生嚴重副作用，應立即停藥並改用其它非fluoroquinolone類藥品繼續完成治療療程。

相關訊息與連結請參考FDA網址：

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm513065.htm 

[Posted 07/26/2016]

資料來源：美國FDA之藥物安全警訊

資料提供：台大醫院藥劑部