Stronger WARNINGS will lead to more concerns about quinolone risks. Quinolone labels already caution about hypo- and hyperglycemia, and certain CNS effects such as agitation, nervousness, or confusion.
Now FDA will require warnings of hypoglycemic coma especially in the elderly, renal impairment, or in combination with insulin or a sulfonylurea. Plus, quinolone labels will get warnings of additional CNS effects such as delirium, impaired memory, and inattention. These hypoglycemic and CNS effects are rare. But they're not limited to high quinolone doses or prolonged courses and it's too soon to say whether one quinolone is riskier than another. Point out the warnings only apply to oral and injectable quinolones. But this adds to previous quinolone concerns about resistance, tendon rupture, peripheral neuropathy and QT prolongation, etc.
- Continue to recommend saving quinolones for patients with complicated infections or those who don't respond to other antibiotics.
- Be ready with alternatives, such as nitrofurantoin or TMP/SMX for most UNcomplicated UTIs, or azithromycin or doxycycline for many patients with community-acquired pneumonia IF they're otherwise healthy.
- Educate how to recognize and treat hypoglycemia and advise glucose monitoring if a quinolone is used along with insulin or a sulfonylurea. Counsel patients to report changes in attention, memory, etc.
REFERENCES
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Research, C. for D.E. and (2019). FDA reinforces safety information about serious low blood sugar levels and mental health side effects with fluoroquinolone antibiotics; requires label changes. FDA. [online] Available at: https://www.fda.gov/drugs/drug-safety-and-availability/fda-reinforces-safety-information-about-serious-low-blood-sugar-levels-and-mental-health-side
Sousa, J., Alves, G., Fortuna, A. and Falcao, A. (2014). Third and Fourth Generation Fluoroquinolone Antibacterials: A Systematic Review of Safety and Toxicity Profiles. Current Drug Safety, 9(2), pp.89–105. Available at: https://pubmed.ncbi.nlm.nih.gov/24410307
Parekh, T.M., Raji, M., Lin, Y.-L., Tan, A., Kuo, Y.-F. and Goodwin, J.S. (2014). Hypoglycemia After Antimicrobial Drug Prescription for Older Patients Using Sulfonylureas. JAMA internal medicine, [online] 174(10), pp.1605–1612. Available at: 10.1001/jamainternmed.2014.3293