Safety Warning Issued for Fluoroquinolone Antibiotics
November 1, 2018 4 minutes read
By Rebecca Bowers
EXECUTIVE SUMMARY
The federal Food and Drug Administration (FDA) now is asking clinicians to consider other treatment options besides fluoroquinolone antibiotics because of risks associated with their use.
- The action comes with labeling changes warning of the potential risk of hypoglycemic coma and certain adverse mental health effects, such as problems with attention and memory, disorientation, agitation, nervousness, and delirium, associated with use of the drugs.
- For acute bacterial sinusitis, acute exacerbation of chronic bronchitis, and uncomplicated urinary tract infections, clinicians should reserve the use of fluoroquinolones for patients without other options for treatment.
Check your clinical practice when it comes to treatment of uncomplicated urinary tract infections (UTIs) — the federal Food and Drug Administration (FDA) now is asking clinicians to consider other treatment options besides fluoroquinolone antibiotics because of risks associated with their use.1 The action comes with labeling changes warning of the potential risk of hypoglycemic coma and certain adverse mental health effects, such as problems with attention and memory, disorientation, agitation, nervousness, and delirium, associated with use of the drugs.
Examples of fluoroquinolones approved by the FDA are levofloxacin, ciprofloxacin, ciprofloxacin extended-release tablets, moxifloxacin, ofloxacin, gemifloxacin, and delafloxacin. The regulatory agency issued a previous safety communication in 2016 concerning oral and injectable fluoroquinolone antibiotics and the risk of adverse effects to tendons, muscles, and joints, as well as to nerves and the central nervous system that can occur together in the same patient. Such side effects may be permanent and can happen hours to weeks after exposure to fluoroquinolone medications, the FDA noted.
In its latest communication, the FDA has determined that for patients with acute bacterial sinusitis, acute exacerbation of chronic bronchitis, and uncomplicated UTIs, clinicians should reserve fluoroquinolone use for patients who do not have other options for treatment. In cases of serious bacterial infections, such as anthrax, plague, and bacterial pneumonia, the benefits of using fluoroquinolone antibiotics outweigh the medication risks, making them an appropriate therapeutic option.
“The use of fluoroquinolones has a place in the treatment of serious bacterial infections — such as certain types of bacterial pneumonia — where the benefits of these drugs outweigh the risks, and they should remain available as a therapeutic option,” said Edward Cox, MD, director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research, in a press statement. “The FDA remains committed to keeping the risk information about these products current and comprehensive to ensure that health care providers and patients consider the risks and benefits of fluoroquinolones and make an informed decision about their use.”
What to Use for UTIs?
Clinicians are very familiar with UTIs. About 62.7 million adults 20 years of age and older have reported having at least one UTI — and 81% of them were women.2 Asymptomatic bacteriuria is more prevalent among women than men. Approximately 5-6% of young women who are sexually active and not pregnant experience asymptomatic bacteriuria, compared to less than 0.1% of young men who do.3
Most cases of UTI are caused by an infection that travels from the urethra to the bladder. Urethral massage, sexual intercourse, or mechanical instrumentation can allow bacteria to move up the urethra, with colonization and infection occurring in the bladder. Uropathogenic Escherichia coli causes approximately 80-90% of UTIs.4 Staphylococcus saprophyticus often is the cause of UTIs in the lower urinary tract. The bacteria have been found in about 3% of sexually active, reproductive-age, nonpregnant women with pyelonephritis.5
Women with acute bacterial cystitis typically present with symptoms such as difficult or painful urination and urinary frequency or urgency because of irritation of the mucosa in the urethra and bladder. They also may report suprapubic pain or pressure. Using a clean-voided midstream urine sample, a reading of 100,000 single isolate bacteria per milliliter has been considered an indicator of significant bacteriuria. This provides good specificity, but a 50% sensitivity.6 Decreasing the colony count to 1,000-10,000 bacteria per milliliter in patients who are symptomatic can improve sensitivity without significantly compromising the specificity.
According to guidance from the Centers for Disease Control and Prevention, nitrofurantoin, trimethoprim-sulfamethoxazole (TMP-SMX, in areas where local resistance is less than 20%), and fosfomycin are appropriate first-line agents to treat acute uncomplicated cystitis in healthy, adult, nonpregnant, premenopausal women. Fluoroquinolones, such as ciprofloxacin, should be saved for situations in which other agents are not appropriate.7 The current recommended treatment for uncomplicated acute bacterial cystitis in women is a three-day antimicrobial regimen.8
REFERENCES
- U.S. Food and Drug Administration. FDA Drug Safety Communication: FDA reinforces safety information about serious low blood sugar levels and mental health side effects with fluoroquinolone antibiotics; requires label changes. Silver Spring, MD: FDA; 2018. Available at: https://bit.ly/2NhWx0v. Accessed Sept. 19, 2018.
- Griebling TL. Urinary tract infection in women. In: National Institute of Diabetes and Digestive and Kidney Diseases. Urologic Diseases in America. NIH Publication No. 07-5512. Washington, DC: U.S. Government Printing Office; 2007: 587-619.
- Hooton TM, Stamm WE. The vaginal flora and urinary tract infections. In: Mobley HL, Warren JW. Urinary Tract Infections: Molecular Pathogenesis and Clinical Management. Washington, DC: American Society for Microbiology Press; 1996: 67-94.
- Ronald A. The etiology of urinary tract infection: Traditional and emerging pathogens. Am J Med 2002;113 (Suppl 1A):14S-19S.
- Scholes D, Hooton TM, Roberts PL, et al. Risk factors associated with acute pyelonephritis in healthy women. Ann Intern Med 2005;142:20-27.
- Fihn SD. Clinical practice. Acute uncomplicated urinary tract infection in women. N Engl J Med 2003;349:259-266.
- Centers for Disease Control and Prevention. Antibiotic Prescribing and Use in Doctor’s Office. Available at: https://bit.ly/2Q5oYNK. Accessed Sept. 19, 2018.
- American College of Obstetricians and Gynecologists. ACOG Practice Bulletin No. 91: Treatment of urinary tract infections in nonpregnant women. Obstet Gynecol 2008;111:785-794.
The federal Food and Drug Administration (FDA) now is asking clinicians to consider other treatment options besides fluoroquinolone antibiotics because of risks associated with their use.
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