2016年5月13日金曜日

米国FDA薬剤安全性情報:非合併症感染者へのキノロン処方制限・厳格化


フルオロキノロン全身投与、錠剤、カプセル剤、注射剤問わず、腱、筋肉、関節、神経、中枢神経系を含む障害発生、時に永続性障害を生じる可能性懸念の結果、安全性情報アップデート


FDA Drug Safety Communication: FDA advises restricting fluoroquinolone antibiotic use for certain uncomplicated infections; warns about disabling side effects that can occur together
http://www.fda.gov/Drugs/DrugSafety/ucm500143.htm




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, we are requiring the drug labels and Medication Guides for all fluoroquinolone antibacterial drugs to be updated to reflect this new safety information. We are continuing to investigate safety issues with fluoroquinolones and will update the public with additional information if it becomes available.


専門家向け
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.



Moxifloxacin
Ciprofloxacin
Ciprofloxacin extended-release
Gemifloxacin
Levofloxacin
Moxifloxacin
Ofloxacin


Garenoxacinは・・・米国承認されてない




腱炎、腱損傷リスクについて2008年警告
http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm126085.htm




COPDに関して台湾内住民研究後顧的検討によれば・・・
Fluoroquinolones versus β-Lactam/β-Lactamase Inhibitors in Outpatients with Chronic Obstructive Pulmonary Disease and Pneumonia: A Nationwide Population-Based Study
Kuan-Yin Lin, et. al.
Published: August 25, 2015http://dx.doi.org/10.1371/journal.pone.0136232
http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0136232
フルオロキノロン系とβ-lactam/β-lactamase inhibitorは同等の臨床効果

現行UPTODATEによると
リスク要素のないCOPDにおいて、「advanced macrolide or cephalosporin or Doxycycline or Trimethoprim/sulfamethoxazole」をまず処方
ただ、65歳超/FEV1%pred. < 50%/年3回以上の急性増悪/心疾患合併ではFluoroquinolone or Amoxicillin/clavulanate(緑膿菌リスクに配慮して処方)となっている




尿路感染
http://www.chemotherapy.or.jp/guideline/jaidjsc-kansenshochiryo_nyouro.pdf

これでは、真っ先にキノロン処方する罠





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