3/23/2017. Kathryn G. Smith, PharmD PGY1 Pharmacy Resident Via Christi Hospitals Wichita, Inc. Kathryn G. Smith: Nothing to disclose

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1 Kathryn G. Smith, PharmD PGY1 Pharmacy Resident Via Christi Hospitals Wichita, Inc Kathryn G. Smith: Nothing to disclose Describe the new updates and rationale for them Relay safety concerns with use of fluoroquinolones (FQ) List appropriate alternatives to FQ 1

2 July 26, FDA approved label changes Boxed Warning Warnings and Precautions Indications and Usage Updated Medication Guides for patients FDA Drug Safety Communication Available at: Associated with disabling and potentially permanent side effects Tendons, muscles, and peripheral and central nervous systems Risk outweighs the benefit Acute bacterial sinusitis (ABS) Acute bacterial exacerbation of chronic bronchitis (ABECB) Uncomplicated urinary tract infections (uuti) FDA Drug Safety Communication Available at: Black Box Warnings Tendinitis and tendon ruptures Central nervous system effects Peripheral neuropathy Exacerbation of Myasthenia Gravis Warnings and Precautions Clostridium difficile-associated diarrhea Photosensitivity Prolongation of QT interval Daily Med. Levofloxacin. Available at: 2

3 Use of antibacterial agents inhibits normal flora Risk with nearly all antibacterial agents Mild diarrhea to fatal colitis Modifiable risk factor Antibiotic Class Hazard Ratio Fluoroquinolones rd and 4 th generation cephalosporins st and 2 nd generation cephalosporins 2.4 β-lactamase inhibitor combinations 2.3 Sulfas 1.9 Penicillins 1.9 Metronidazole 0.3 Stevens, et al. Clin Infect Dis FDA Adverse Event Reporting System Identified 178 U.S. cases November 1997-May 2015 Previously healthy individuals FQ to treat ABS, ABECB, or uncomplicated UTI Lasting longer than a month Involving two or more body systems FQAD = Fluoroquinolone-associated disability 3

4 Age: 74% were years old 17% were 60 years old Sex: 78% were female Reported Indication: 47% for cystitis/uti Onset of AE: 48% within 1-2 days Overall: 23% reported AE 1 year Mean: 14 months Longest: 9 years Total Disability Reports (n=1122) Total FQAD Cases (n=178) Levofloxacin Ciprofloxacin Moxifloxacin 4

5 Percentage of Disability Reports (%) Azithromycin Cephalexin Amox/Clav Doxycycline Amoxicillin Nitrofurantoin Cefdinir Moxifloxacin Gemifloxacin Levofloxacin Ciprofloxacin Ofloxacin Levofloxacin (n=91) Ciprofloxacin (n=65) Moxifloxacin (n=19) Musculoskeletal 98% 94% 95% Peripheral Nervous System 52% 78% 79% 38% Neuropsychiatric 74% 66% 65% Senses 30% 31% 30% Cardiovascular 10% 12% 10% Skin 10% 15% 15% 5

6 Duration 4 weeks Bacterial infection suspected: Nasal purulence + severe/persistent symptoms days Watchful waiting with symptomatic relief Treatment failure? Prescribe antibiotic Amoxicillin Clavulanate 875/125 mg PO BID x days* Azithromycin 2 g x 1 dose or 500 mg PO daily x 3 days Doxycycline 100 mg PO BID x days* TMP SMX DS 1 tab BID x days* *5 7 day duration may be appropriate for adults Chow AW, et al. Clin Infect Dis. 2012;54(8):e72 e112 Rosenfeld RM, et al. Otolaryng Head Neck. 2015; 152(4) Bartlett JG, et al. (2012). ABX Guide. Burlington, MA: Jones & Bartlett Learning Assess for cardinal symptoms: Increased dyspnea Increased sputum volume Increased sputum purulence Age >65 or cardiac disease or 3 exacerbations/year Amoxicillinclavulanate 875/125 mg PO BID x 7 days Doxycycline 100 mg PO BID x 7 days Cefdinir 300 mg PO BID x 7 days Cefuroxime 500 mg PO BID x 10 days Azithromycin 500 mg PO x 1 day, then 250 x 4 days Lee H, Am Fam Physician Nov 15;88(10): mg PO BID x 5 days Do not use: CrCl <40mL/min Avoid use in 65 yo 40% unchanged in urine DS 1 tab PO BID x 3 days CrCl >30 ml/min 40% unchanged in urine 500 mg PO q6 8h x 5 7 days CrCl >30 ml/min 80% unchanged in urine 3 g PO x 1 dose 30 40% bioavailability 100% unchanged in urine 875/125 mg PO BID x 5 7 days CrCl >30 ml/min 60% unchanged in urine *Beta lactams can be considered if other agents cannot be used. Treatment with antibiotics is only indicated if patient is symptomatic or pregnant Gupta K, et al. Clin Infect Dis. 2011;52(5):e103 e120 Bartlett JG, et al. (2012). ABX Guide. Burlington, MA: Jones & Bartlett Learning 6

7 FQ are associated with severe disabling events Can involve several body systems at once High risk of C. difficile-associated diarrhea Variety of alternative antibacterial options available Education to patients and physicians can be beneficial Kathryn G. Smith, PharmD PGY1 Pharmacy Resident Via Christi Hospitals Wichita, Inc 7