藥物警訊

Fluoroquinolone Antibacterial Drugs: Drug Safety Communication- Risk for possibly permanent nerve damage

AUDIENCE: Family Practice, Infectious Disease, Pharmacy

ISSUE: FDA has required the drug labels and Medication Guides for all fluoroquinolone antibacterial drugs be updated to better describe the serious side effect of peripheral neuropathy. This serious nerve damage potentially caused by fluoroquinolones may occur soon after these drugs are taken and may be permanent.

BACKGROUND: The risk of peripheral neuropathy occurs only with fluoroquinolones that are taken by mouth or by injection. Approved fluoroquinolone drugs include levofloxacin (Levaquin), ciprofloxacin (Cipro), moxifloxacin (Avelox), norfloxacin (Noroxin), ofloxacin (Floxin), and gemifloxacin (Factive). The topical formulations of fluoroquinolones, applied to the ears or eyes, are not known to be associated with this risk.

RECOMMENDATION: Make sure your patients know to contact you if they develop symptoms of peripheral neuropathy. Make sure your patients receive the Medication Guide with every prescription. If a patient develops symptoms of peripheral neuropathy, the fluoroquinolone should be stopped, and the patient should be switched to another, non-fluoroquinolone antibacterial drug, unless the benefit of continued treatment with a fluoroquinolone outweighs the risk.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

‧ Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
‧ Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

Read the complete MedWatch Safety Alert, including a link to the Drug Safety Communication, at:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHuma...

FDA要求更新所有fluoroquinolone類抗生素的藥品仿單和用藥指引，新增可能產生嚴重周圍神經病變副作用的警語描述。此嚴重神經傷害可能會於使用fluoroquinolone類抗生素後立即出現，且可能造成永久性傷害。

背景

周邊神經病變風險只發生於口服或注射fluoroquinolone；塗抹於眼睛或耳朵的外用製劑，其風險目前未知。

建議

醫療人員需提醒病人，若發生任何與周邊神經病變相關之症狀，請立即就醫；若病人產生任何相關症狀，除非使用此藥的利益大於風險，否則應停用fluoroquinolone，並轉換為非fluoroquinolone類之藥物。
 

相關訊息與連結請參考FDA網址：http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm365302.htm
 

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