The FDA has approved the new aminoglycoside antibiotic plazomicin (Zemdri – Achaogen) for IV treatment of adults with complicated urinary tract infections (cUTIs). Plazomicin is active against multi-drug- resistant Enterobacteriaceae, including strains resistant to other aminoglycosides.

The FDA has required changes in the labeling of all systemic fluoroquinolone antibiotics to strengthen warnings about the risk of severe hypoglycemia and mental health effects associated with their use.1

An FDA review identified 67 cases of hypoglycemic coma associated with fluoroquinolone use, 22 of which resulted in death or disability. Most cases occurred in patients with risk factors such as diabetes (especially those taking a sulfonylurea), older age, or renal insufficiency.1 In observational studies in older adults and patients with diabetes, fluoroquinolones have been associated with increased risks of hypo- and hyperglycemia.2,3 Patients taking a fluoroquinolone (especially those with risk factors) should be counseled about the symptoms of hypoglycemia and monitored for blood glucose disturbances. The drug should be stopped if dysglycemia occurs.

The labels of all systemic fluoroquinolones will now include warnings about delirium, agitation, nervousness, and disturbances in attention, memory, and orientation. These effects can occur after a single fluoroquinolone dose; the drug should be stopped if such effects occur. Systemic fluoroquinolones can also cause persistent or permanent peripheral neuropathy,4 and their use has been associated with an increased risk of pseudotumor cerebri syndrome.5

Other serious adverse effects associated with use of systemic fluoroquinolones include tendinitis and tendon rupture, exacerbation of myasthenia gravis, Clostridium difficile infection, and (except for delafloxacin [Baxdela]) QT-interval prolongation and torsades de pointes. The FDA recommends avoiding use of fluoroquinolones in patients with uncomplicated urinary tract infection, acute sinusitis, or acute exacerbation of chronic bronchitis, except when no alternative treatment option is available.6

Additional Content Available Online: Comparison Table: Some Systemic Fluoroquinolones

1. FDA. July 10, 2018. Available at: www.fda.gov. Accessed August 2, 2018.
2. LY Park-Wyllie et al. Outpatient gatifloxacin therapy and dysglycemia in older adults. N Engl J Med 2006; 354:1352.
3. HW Chou et al. Risk of severe dysglycemia among diabetic patients receiving levofloxacin, ciprofloxacin, or moxifloxacin in Taiwan. Clin Infect Dis 2013; 57:971.
4. In brief: Fluoroquinolones and peripheral neuropathy. Med Lett Drugs Ther 2013; 55:89.
5. M Sodhi et al. Oral fluoroquinolones and risk of secondary pseudotumor cerebri syndrome: nested case-control study. Neurology 2017; 89:792.
6. Alternatives to fluoroquinolones. Med Lett Drugs Ther 2016; 58:75.

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The FDA has approved vancomycin oral solution (Firvanq – Cutis Pharma) for treatment of Clostridium difficile-associated diarrhea and enterocolitis caused by Staphylococcus aureus, including methicillin-resistant strains (MRSA).

Bacterial infections in adults are generally treated empirically, with the antibiotic covering most, but not all, of the potential causative pathogens. For some infections, culture and sensitivity testing can guide treatment, allowing for use of narrower-spectrum antibiotics. The recommended dosages and durations of antibiotic treatment for common respiratory, skin, and urinary tract infections are listed in Tables 1-3. Infectious disease experts now recommend shorter treatment durations for many infections to reduce the development of antimicrobial resistance and minimize adverse effects.

Proton pump inhibitors (PPIs), which are used for treatment of gastroesophageal reflux disease (GERD) and for prevention of upper gastrointestinal adverse effects caused by NSAIDs and aspirin, are one of the most commonly prescribed classes of drugs in the US. All PPIs are similarly effective and generally well tolerated, but their long-term use has been associated with a number of safety concerns. Recommendations addressing these concerns have recently been published.

About 50% of the world’s population is infected with Helicobacter pylori. These gastric bacteria can cause chronic inflammation and have been associated with development of gastritis, peptic ulcer disease, gastric adenocarcinoma, and gastric mucosa-associated lymphoid tissue (MALT) lymphoma. Eradication of H. pylori can promote gastric healing, prevent recurrence of duodenal and gastric ulcers, and reduce the incidence of gastric cancer. Guidelines for treatment of H. pylori infection were updated recently.

Clostridium difficile infection (CDI) is the most common infectious cause of healthcare-associated diarrhea in adults. The incidence and severity of CDI have increased in recent years with the emergence of an epidemic virulent strain (NAP1/BI/027). Common risk factors include admission to a healthcare facility, increasing age and severity of underlying illness, gastric acid suppression and exposure to antimicrobials, particularly clindamycin, ampicillin, cephalosporins or fluoroquinolones. Patients who develop CDI while receiving a precipitating antibiotic should have the antibiotic discontinued, if possible, or switched to another appropriate antimicrobial with a lower risk of CDI.

In the recent Medical Letter article on the treatment of Clostridium difficile–associated disease (CDAD) we wrote: “Healthcare workers caring for patients with C. difficile infection should follow contact isolation precautions, especially use of gloves and hand washing with soap and water after glove removal. Alcohol-based products such as hand sanitizers will not eradicate C. difficile spores.”1 One reader pointed out that alcoholbased products do eradicate some C. difficile spores and have been invaluable against other pathogens.

In an unpublished study available as an abstract, both alcohol-based hand gels and chlorhexidine washes reduced the number of C. difficile spores on contaminated hands, but chlorhexidine was more effective (8 spores/cm2 remaining vs. 30-44 spores/cm2 with 3 formulations of alcohol-based hand gels).2 A previous study showed that chlorhexidine was not different from soap in removal of spores.3 Alcohol itself should have no effect on spores (purified spores are frequently stored in alcohol), but the mechanical action of washing hands with alcohol-based products may be effective in removing them. The CDC has recommended that healthcare workers caring for patients with known or suspected CDAD use contact precautions and perform hand hygiene with either an alcohol-based hand rub or soap and water, except in an outbreak setting, where exclusive use of soap and water should be considered.4

1. Treatment of Clostridium difficile–associated disease (CDAD). Med Lett Drugs Ther 2006; 48:89.

2. J Leischner et al. Effect of alcohol hand gels and chlorhexidine hand wash in removing spores of Clostridium difficile (CD) from hands. Intersci Conf Antimicrob Agent Chemother (ICAAC), Washington, DC 2005, abstract LB-29-2005.

3. K Bettin et al. Effectiveness of liquid soap vs. chlorhexidine gluconate for the removal of Clostridium difficile from bare hands and gloved hands. Infect Control Hosp Epidemiol 1994; 15:697.

4. CDC. Clostridium difficile information for healthcare providers (www.cdc.gov/ncidod/dhqp/id_CdiffFAQ_HCP.html; accessed January 22, 2007).

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