Toxicity Warnings

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Fluoroquinolone toxicity is far beyond a list of product side effects; it can be profoundly life-altering. Many people who have experienced these reactions describe them as among the most devastating events of their lives, with the potential to affect health, work, relationships, independence, and daily living.   

Consistent with FDA and EMA safety warnings, serious fluoroquinolone adverse reactions may begin during treatment or occur hours to weeks after exposure. These reactions may be prolonged, disabling, or potentially irreversible, and may affect several, sometimes multiple, body systems. Some of these adverse effects may not be visible to others and are often poorly understood. A major concern is that, based on our Foundation’s survey data and reports from fluoroquinolone support groups, most patients state they were not warned that multiple symptoms could occur together, or that these reactions could become prolonged, disabling, or potentially permanent.

While laboratory and animal studies have contributed important scientific findings, patient-based fluoroquinolone research has remained limited. One important early patient study was conducted by Jay S. Cohen, M.D., a trailblazer in fluoroquinolone awareness, whose work helped document the wide range and seriousness of reported fluoroquinolone reactions. 

Dr. Cohen was a faculty member at the University of California San Diego for decades. He was an avid champion on drug safety and his works included numerous articles in top medical journals as well as his book, How We Can Halt The Cipro & Levaquin Catastrophe: The Worst Medication Disaster In U.S. History. In response to Dr. Cohen’s fluoroquinolone article published in the Annals of Pharmacotherapy and appearance on National Public Radio, the CDC withdrew its recommendation for Cipro usage for the 2001 anthrax attacks. Dr. Cohen has since passed away, but his work has not gone in vain. A segment of his letter to the Senate Committee in 2014 follows with a link below to its entirety:

…"I have been following these medications for 16 years and have evaluated in person or by telephone consultation more than 300-400 people injured by Fluoroquinolones. In 2001, I published an article, “Peripheral Neuropathy with Fluoroquinolone Antibiotics”, in the peer reviewed journal Annals of Pharmacotherapy. This article described 45 cases of severe neurological symptoms such as tingling, numbness, burning pain, twitching, and/or weakness. Moreover, 93% of the subjects manifested symptoms in other injuries to other vital systems: agitation, impaired cognitive function, intractable insomnia, hallucinations, psychosis, acute manic episode, joint or muscle pain, or tendon rupture. In many cases, toxicities also involved the cardiovascular and gastrointestinal systems, skin, and sight or hearing. Overall, ninety percent of my subjects experienced toxicity to multiple body systems. Hence my coining the term Fluoroquinolone Toxicity Syndrome…"

Forty-five subjects in Dr. Cohen’s study reported the following adverse effects.[1]

Peripheral Nervous System (PNS): Tingling, numbness, prickling, burning pain, pins/needles sensation, electrical or shooting pain, skin crawling sensation, hyperesthesia, hypoesthesia, allodynia, numbness, weakness, twitching, tremors, spasms.

Central Nervous System (CNS): Dizziness, malaise, weakness, impaired coordination, nightmares, insomnia, headaches, agitation, anxiety, panic attacks, disorientation, impaired concentration or memory, confusion, depersonalization, hallucinations, psychoses.

Musculoskeletal: Muscle pain, weakness, soreness; joint swelling, pain; tendon pain, ruptures.

Special Senses: Diminished or altered visual, olfactory, auditory functioning, tinnitus.

Cardiovascular: Tachycardia, shortness of breath, hypertension, palpitations, chest pain.

Skin: Rash, swelling, hair loss, sweating, intolerance to heat and\or cold.

Gastrointestinal: Nausea, vomiting, diarrhea, abdominal pain.

Forty-two patients (93%) experienced symptoms involving systems outside the PNS; many experienced symptoms in multiple organ systems. CNS symptoms were reported in 78% of cases; musculoskeletal symptoms, 73%; special senses, 42%; cardiovascular, 36%; skin, 29% and gastrointestinal, 18%.

 [1] Cohen, Jay S. Dr.  December 2001, vol. 35  Peripheral Neuropathy Associated with Fluoroquinolones.   The Annals of Pharmacotherapy.  https://www.academia.edu/11210092/Peripheral_neuropathy_associated_with_fluoroquinolone