FDA Black Box Warnings & Alerts
A Black Box warning is the highest safety-related warning that medications can have assigned by the Food and Drug Administration (FDA). The FDA’s major boxed warnings and label changes for fluoroquinolones apply to systemic formulations - oral and injectable/IV products. FDA labeling for some fluoroquinolone eye and ear products acknowledge systemic absorption or systemic quinolone-type hypersensitivity warnings, although these products do not carry the same boxed warning language required for the oral and injectable/IV.
FDA warnings state that systemic fluoroquinolones are associated with disabling and potentially permanent serious side effects involving the tendons, muscles, joints, nerves, and central nervous system, which can occur together in the same patient. FDA warnings also include risks of peripheral neuropathy, mental health side effects, serious low blood sugar, tendon rupture, possible aortic aneurysm or dissection, and worsening of myasthenia gravis.
The FDA advises reserving fluoroquinolones for certain uncomplicated infections when there are no suitable alternative treatment options, because the risks may outweigh the benefits.
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FDA Safety Announcement, December 20, 2018:
Fluoroquinolone antibiotics can increase the occurrence of rare but serious events of ruptures or tears in the main artery of the body, called the aorta.
FDA Safety Announcement, July 10, 2018:
FDA reinforces safety information about serious low blood sugar levels and mental health side effects with fluoroquinolone antibiotics; requires label changes.
FDA Drug Safety Communication, July 26, 2016:
FDA updates warnings for oral and injectable fluoroquinolone antibiotics due to disabling side effects.
FDA Drug Safety Communication, May 12, 2016:
FDA advises restricting fluoroquinolone antibiotic use for certain uncomplicated infections; warns about disabling side effects that can occur together.
FDA Safety Announcement August 2013:
FDA requires label changes to warn of risk for possibly permanent nerve damage from antibacterial fluoroquinolone drugs taken by mouth or by injection. Peripheral neuropathy is a nerve
disorder occurring in the arms or legs. Symptoms include pain, burning, tingling, numbness, weakness,
or a change in sensation to light touch, pain or temperature, or the sense of body position. It can occur
at any time during treatment with fluoroquinolones and can last for months to years after the drug is
stopped or be permanent.
https://wayback.archive-it.org/7993/20170112031629/http:/www.fda.gov/Drugs/DrugSafety/ucm365050.htm
FDA Black Box Warning added February 2011:
Fluoroquinolones, have neuromuscular blocking activity and may exacerbate muscle weakness in persons with myasthenia gravis. Postmarketing serious adverse events, including deaths and requirement for ventilatory support, have been associated with fluoroquinolone use in persons with myasthenia gravis. Avoid fluoroquinolones in patients with known history of myasthenia gravis.
FDA Black Box Warning added in 2008:
Fluoroquinolones are associated with an increased risk of tendinitis and tendon rupture, this risk is further increased in older patients usually over 60 years of age, in patients taking corticosteroid drugs, and in patients with kidney, heart or lung transplants.
Multiple FDA Warnings, Updates & Articles in English & Spanish:
https://www.fda.gov/search?s=+Fluoroquinolone&sort_bef_combine=rel_DESC
Fluoroquinolone Detailed Medication Guide & Label Changes
FDA Levaquin Label 06/28/2019
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020634s069lbl.pdf#page=51
FDA Cipro Label 05/03/2019
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/019537s089,020780s046lbl.pdf#page=38
FDA Avelox 05/03/2019
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021085s065,021277s061lbl.pdf#page=33
FDA: Post-Marketing Adverse Event Reports:
The following adverse events have been reported from worldwide marketing experience with fluoroquinolones. Because these events are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Decisions to include these events in labeling are typically based on one or more of the following factors: (1) seriousness of the event, (2) frequency of the reporting, or (3) strength of causal connection to the drug:
Agitation, agranulocytosis, albuminuria, anaphylactic reactions (including life-
threatening anaphylactic shock), anosmia, candiduria, cholesterol elevation (serum),
confusion, constipation, delirium, dyspepsia, dysphagia, erythema multiforme,
exfoliative dermatitis, fixed eruption, flatulence, glucose elevation (blood), hemolytic
anemia, hepatic failure (including fatal cases), hepatic necrosis, hyperesthesia,
hypertonia, hypesthesia, hypotension (postural), jaundice, marrow depression (life
threatening), methemoglobinemia, moniliasis (oral, gastrointestinal, vaginal),
myalgia, myasthenia, exacerbation of myasthenia gravis (possible exacerbation),
myoclonus, nystagmus, pancreatitis, pancytopenia (life threatening or fatal outcome),
peripheral neuropathy, phenytoin alteration (serum), photosensitivity/phototoxicity
reaction, potassium elevation (serum), prothrombin time prolongation or decrease,
pseudomembranous colitis (The onset of pseudomembranous colitis symptoms may
occur during or after antimicrobial treatment.), psychosis (toxic), renal calculi, serum
sickness like reaction, Stevens-Johnson syndrome, taste loss, tendinitis, tendon
rupture, torsade de pointes, toxic epidermal necrolysis (Lyell’s Syndrome),
triglyceride elevation (serum), twitching, vaginal candidiasis, and vasculitis.
See full document here:
Fluoroquinolone Associated Disability
In 2015, after victim testimonies before the Antimicrobial Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee of the FDA, a cluster of recognized symptoms became known as FQAD (Fluoroquinolone Associated Disability). The CDC has yet to officially adopt FQAD as a distinct diagnosis.
View the FDA presentation: https://www.fda.gov/media/104060/download
FDA Definition of FQAD
Submit adverse reactions to the FDA
It is crucial that patients or doctors witnessing adverse effects file a report with the FDA Medwatch. If you don't report it, this condition is deemed rare. You may file a report each year you continue to experience issues: https://www.fda.gov/safety/report-problem-fda
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