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One of the biggest-selling but most overprescribed classes of antibiotics in the United States is the family called fluoroquinolones.[1],[2] These antibiotics can be used to treat bacterial infections in many parts of the body.
However, fluoroquinolones — like many other antibiotics — are commonly incorrectly prescribed for viral infections, such as colds and most sore throats, which do not respond to antibiotics.[3],[4],[5] In addition, the drugs often are used to treat bacterial...
One of the biggest-selling but most overprescribed classes of antibiotics in the United States is the family called fluoroquinolones.[1],[2] These antibiotics can be used to treat bacterial infections in many parts of the body.
However, fluoroquinolones — like many other antibiotics — are commonly incorrectly prescribed for viral infections, such as colds and most sore throats, which do not respond to antibiotics.[3],[4],[5] In addition, the drugs often are used to treat bacterial infections, such as acute bladder infections, when other, safer antibiotics that are equally or more effective should be the first choice.[6],[7] Such misuse of fluoroquinolones exposes patients to the risk of a variety of potentially serious, avoidable adverse effects.
In 2016, in an effort to rein in the overprescribing of fluoroquinolones, the Food and Drug Administration (FDA) required the addition of new black-box warnings — the agency’s strongest drug product warning — to the antibiotics’ labels.[8],[9] The new warnings state that these antibiotics, when taken orally or by injection, carry risks of several disabling and potentially permanent side effects, including nerve and brain damage. The agency further advised doctors and patients that for several common types of infections, fluoroquinolones should be used only if there is no other treatment option, because these serious side effects outweigh the drugs’ benefits.
Two of five: Do Not Use
Five fluoroquinolones are currently available in either oral or injection form in the U.S. (see table, below). Each has been approved by the FDA for treating several types of infections. These antibiotics are easily recognized as members of the fluoroquinolone family because their generic names all end with “floxacin.”
Fluoroquinolones Available in the U.S. for Oral or Intravenous (IV) Use
| Generic Name | Brand Name | Available Forms | FDA-Approved Uses |
|---|---|---|---|
| ciprofloxacin (Limited Use) | CIPRO, CIPRO XR | oral,IV | Abdominal infections, acute sinusitis, anthrax, bone and joint infections, chronic prostatitis, gonorrhea, infectious diarrhea, plague, pneumonia, skin infections, sudden worsening of chronic bronchitis due to a bacterial infection, typhoid fever, urinary tract infections (including acute bladder infection)[10] |
| gemifloxacin (Do Not Use) | FACTIVE | oral | Community-acquired (as opposed to hospital-acquired) pneumonia, sudden worsening of chronic bronchitis due to a bacterial infection[11] |
| levofloxacin (Limited Use) | LEVAQUIN | oral, IV | Acute sinusitis, anthrax, chronic prostatitis, hospital- and community-acquired pneumonia, plague, skin infections, sudden worsening of chronic bronchitis due to a bacterial infection, urinary tract infections (including acute bladder infection)[12] |
| moxifloxacin (Do Not Use) | AVELOX | oral, IV | Abdominal infections, acute sinusitis, community-acquired pneumonia, plague, skin infections, sudden worsening of chronic bronchitis due to a bacterial infection[13] |
| ofloxacin (Limited Use) | Generic only | oral | Acute pelvic inflammatory disease, chlamydia, community-acquired pneumonia, gonorrhea, prostatitis, skin infections, sudden worsening of chronic bronchitis due to a bacterial infection, urinary tract infections (including acute bladder infection)[14] |
Public Citizen’s Health Research Group has long designated two of the five as Do Not Use. The first is moxifloxacin (AVELOX), which was approved by the FDA in 1999. This antibiotic is no more effective than other fluoroquinolones, and it can cause fatal heart rhythm changes.[15]
The second fluoroquinolone designated as Do Not Use is gemifloxacin (FACTIVE), which was approved by the FDA in 2003. During the course of the FDA’s pre-approval review of gemifloxacin, significant concerns arose regarding potentially serious skin reactions and heart rhythm changes that could lead to sudden death.[16]
We have designated the other fluoroquinolones — ciprofloxacin (CIPRO, CIPRO XR), levofloxacin (LEVAQUIN) and ofloxacin (available only in generic form) — as Limited Use drugs, since they are infrequently the first choice for treating infections.
New FDA warnings
On May 12, 2016, the FDA announced that it was requiring the labels for all oral and injectable fluoroquinolones to include expanded black-box warnings about serious side effects involving the tendons, muscles, nerves and central nervous system (brain and spinal cord).[17] The updated labels containing the new black-box warnings were approved by the agency on July 26, 2016.[18]
Prior to May 2016, the labels for fluoroquinolones already included black-box warnings about tendinitis, tendon rupture and worsening of myasthenia gravis, a rare, serious disease that causes muscle weakness. Tendon adverse reactions most frequently involve the Achilles tendon, the tendon that runs from the back of the heel to the calf. Rupture of the Achilles tendon may require surgical repair. Damage to tendons in the rotator cuff (the shoulder), hand, biceps and thumb have also been seen with fluoroquinolone use.
The expanded black-box warnings now include information on the risks of serious adverse reactions affecting nerves and the central nervous system.[19],[20],[21],[22],[23] This information had been noted in non-black-box warnings found in earlier labeling for fluoroquinolones, but the FDA upgraded the warnings because of concerns about severity of these reactions and evidence of significant overprescribing of these drugs.
Symptoms of nerve damage associated with fluoroquinolone use include painful or burning sensations, tingling, numbness, other abnormal sensations, and weakness.[24] Symptoms of central nervous system injury include psychosis, paranoia, hallucinations, anxiety, confusion, depression, insomnia, dizziness, tremors and severe headaches.[25] The labeling for fluoroquinolones advises that these antibiotics should be discontinued immediately at the first symptoms or signs of any of these serious adverse reactions.[26]
The new warnings also state that adverse reactions affecting tendons, nerves and the central nervous system can occur together in the same patient and can be disabling and irreversible.
The creation of new, stronger warnings for these antibiotics was prompted in part by an FDA review of adverse event reports submitted to the agency: From November 1997 to May 2015, the FDA received reports of 178 cases of apparently healthy patients who experienced disabling side effects lasting longer than a month involving two or more body systems (for example, musculoskeletal system and central nervous system) after being treated with a fluoroquinolone.[27]
The majority of cases (74 percent) reported to the FDA were in patients age 30 to 59. These adverse reactions severely affected many patients’ lives. Effects included job loss and the resulting lack of health insurance, large medical bills, financial problems, and family tension or dissolution. The disabling adverse reactions had lasted an average of 14 months at the time the report was received by FDA, with the longest duration reported being nine years.
Last-resort antibiotics for some infections
The FDA also required that the new black-box warnings and other sections of the labeling for all oral and intravenous fluoroquinolones advise doctors not to prescribe the antibiotics to patients who have other treatment options for the following three common infections:
- Acute bacterial exacerbation of chronic bronchitis (a type of chronic obstructive pulmonary disease, or COPD)
- Acute uncomplicated bladder infection
- Acute sinusitis[28]
The FDA concluded that for these infections, fluoroquinolones’ risks of serious side effects generally outweigh their benefits.
What You Can Do
Whenever your doctor prescribes you a fluoroquinolone, you should ask whether your illness requires any antibiotic and, if so, whether an alternative antibiotic would likely be as or more effective. You should not take a fluoroquinolone for acute exacerbations of chronic bronchitis, acute uncomplicated bladder infection or acute sinusitis, unless there is no other alternative.
If you develop tendon pain or any symptoms of nerve or central nervous system injury while taking a fluoroquinolone, you should immediately contact your doctor so that you can be switched to a different antibiotic in order to decrease your risk of progression to a tendon rupture, permanent nerve damage or permanent central nervous system injury.
You should not discontinue the use of any medication without first consulting your doctor.
References
[1] Werner NL, Hecker MT, Sethi AK, Donskey CJ. Unnecessary use of fluoroquinolone antibiotics in hospitalized patients. BMC Infect Dis. 2011;11:187. doi: 10.1186/1471-2334-11-187
[2] Linder JA, Huang ES, Steinman MA, et al. Fluoroquinolone prescribing in the United States: 1995-2000. Am J Med. 2005;118(3):259-268.
[3] Werner NL, Hecker MT, Sethi AK, Donskey CJ. Unnecessary use of fluoroquinolone antibiotics in hospitalized patients. BMC Infect Dis. 2011;11:187. doi: 10.1186/1471-2334-11-187.
[4] Linder JA, Huang ES, Steinman MA, et al. Fluoroquinolone prescribing in the United States: 1995-2000. Am J Med. 2005;118(3):259-268.
[5] Barnett ML, Linder JA. Antibiotic prescribing to adults with sore throat in the United States, 1997-2010. JAMA Intern Med. 2014;174(1):138-140..
[6] Werner NL, Hecker MT, Sethi AK, Donskey CJ. Unnecessary use of fluoroquinolone antibiotics in hospitalized patients. BMC Infect Dis. 2011;11:187. doi: 10.1186/1471-2334-11-187.
[7] Lautenbach E, Larosa LA, Kasbekar N, et al. Fluoroquinolone utilization in the emergency departments of academic medical centers: Prevalence of, and risk factors for, inappropriate use. Arch Intern Med. 2003;163(5):601-605.
[8] Food and Drug Administration. FDA Drug Safety Communication: FDA advises restricting fluoroquinolone antibiotic use for certain uncomplicated infections; warns about disabling side effects that can occur together. May 12, 2016. http://www.fda.gov/Drugs/DrugSafety/ucm500143.htm. Accessed November 14, 2016.
[9] Food and Drug Administration. FDA Drug Safety Communication: FDA updates warnings for oral and injectable fluoroquinolone antibiotics due to disabling side effects. July 26, 2016. http://www.fda.gov/Drugs/DrugSafety/ucm511530.htm. Accessed November 14, 2016.
[10] Bayer HealthCare Pharmaceuticals. Label: CIPRO (ciprofloxacin hydrochloride). September 2016. http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019537s085,020780s042lbl.pdf. Accessed November 14, 2016.
[11] Merus Labs. Drug label: FACTIVE (gemifloxacin mesylate). July 2016. http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021158s023lbl.pdf. Accessed November 14, 2016.
[12] Janssen Pharmaceuticals. Drug label: LEVAQUIN (levofloxacin). July 2016. http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020634s067,020635s073,021721s034lbl.pdf. Accessed November 14, 2016.
[13] Bayer HealthCare Pharmaceuticals. Drug label: AVELOX (moxifloxacin). September 2016. http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021085s061s062,021277s057s058lbl.pdf. Accessed November 14, 2016.
[14] Larken Laboratories. Drug label: OFLOXACIN (ofloxacin). July 2016. https://dailymed.nlm.nih.gov/dailymed/getFile.cfm?setid=6a3dcc79-bde4-4c32-8a0e-ea14a1e1a191&type=pdf&name=6a3dcc79-bde4-4c32-8a0e-ea14a1e1a191. Accessed November 14, 2016.
[15] Drug profile for gatifloxacin, moxifloxacin, and sparfloxacin. WorstPills.org. Last reviewed April 30, 2016. /monographs/view/256. Accessed November 14, 2016.
[16] Drug profile for gemifloxacin. WorstPills.org. Last reviewed April 30, 2016. /monographs/view/263. Accessed November 14, 2016.
[17] Food and Drug Administration. FDA Drug Safety Communication: FDA advises restricting fluoroquinolone antibiotic use for certain uncomplicated infections; warns about disabling side effects that can occur together. May 12, 2016. http://www.fda.gov/Drugs/DrugSafety/ucm500143.htm. Accessed November 14, 2016.
[18] Food and Drug Administration. FDA Drug Safety Communication: FDA updates warnings for oral and injectable fluoroquinolone antibiotics due to disabling side effects. July 26, 2016. http://www.fda.gov/Drugs/DrugSafety/ucm511530.htm. Accessed November 14, 2016.
[19] Bayer HealthCare Pharmaceuticals. Label: CIPRO (ciprofloxacin hydrochloride). September 2016. http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019537s085,020780s042lbl.pdf. Accessed November 14, 2016.
[20] Merus Labs. Drug label: FACTIVE (gemifloxacin mesylate). July 2016. http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021158s023lbl.pdf. Accessed November 14, 2016.
[21] Janssen Pharmaceuticals. Drug label: LEVAQUIN (levofloxacin). July 2016. http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020634s067,020635s073,021721s034lbl.pdf. Accessed November 14, 2016.
[22] Bayer HealthCare Pharmaceuticals. Drug label: AVELOX (moxifloxacin). September 2016. http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021085s061s062,021277s057s058lbl.pdf. Accessed November 14, 2016.
[23] Larken Laboratories. Drug label: OFLOXACIN (ofloxacin). July 2016. https://dailymed.nlm.nih.gov/dailymed/getFile.cfm?setid=6a3dcc79-bde4-4c32-8a0e-ea14a1e1a191&type=pdf&name=6a3dcc79-bde4-4c32-8a0e-ea14a1e1a191. Accessed November 14, 2016.
[24] Bayer HealthCare Pharmaceuticals. Label: CIPRO (ciprofloxacin hydrochloride) tablet, for oral use; CIPRO (ciprofloxacin hydrochloride), for oral suspension. September 2016. http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019537s085,020780s042lbl.pdf. Accessed November 14, 2016.
[25] Ibid.
[26] Ibid.
[27] Food and Drug Administration. FDA Drug Safety Communication: FDA updates warnings for oral and injectable fluoroquinolone antibiotics due to disabling side effects. July 26, 2016. http://www.fda.gov/Drugs/DrugSafety/ucm511530.htm. Accessed November 14, 2016.
[28] Ibid.
