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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.
The FDA recommends reserving fluoroquinolones for conditions where alternative treatment options are not available.
FDA Warnings: serious adverse reactions including tendinitis, tendon rupture, peripheral neuropathy, central nervous system damage, mental health issues, serious low blood sugar, risk of ruptures or tears in the aorta and exacerbation of myasthenia gravis
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FDA Safety Announcement December 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. These tears, called aortic dissections, or ruptures of an aortic aneurysm can lead to dangerous bleeding or even death.
FDA Safety Announcement July 2018:
FDA reinforces safety information about serious low blood sugar levels and mental health side effects with fluoroquinolone antibiotics; requires label changes.
FDA Black Box Warning Added July 2016:
These medicines are associated with disabling and potentially permanent side effects of the tendons, muscles, joints, nerves, and central nervous system that can occur together in the same patient. As a result, we revised the Boxed Warning, FDA’s strongest warning, to address these serious safety issues. We also added a new warning and updated other parts of the drug label, including the patient Medication Guide.
FDA Press Release May 2016:
Limits use for acute bacterial sinusitis, acute bacterial exacerbation of chronic bronchitis and uncomplicated urinary tract infections.
https://www.fda.gov/news-events/press-announcements/fda-updates-warnings-Fluoroquinolone-antibiotics
FDA Safety Announcement August 2013:
Risk for possible permanent nerve damage (Peripheral Neuropathy); label changes required.
https://wayback.archive-it.org/7993/20170112031629/http:/www.fda.gov/Drugs/DrugSafety/ucm365050.htm
FDA Black Box Warning added in 2008:
Fluoroquinolones are associated with an increased risk of tendinitis and tendon rupture.
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Multiple FDA Warnings & 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, including ciprofloxacin. 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.
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 recognize FQAD. Please note these symptoms do not include many of the severe common adverse effects continually reported in support groups by thousands living with this toxicity and yet to be fully acknowledged by any government entity.
FDA Definition of FQAD
Submit adverse reactions to the FDA
It is crucial that patients or doctors witnessing adverse effects file a report to the FDA. 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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