Why this petition matters:

There is an ongoing worldwide medical crisis that is not being properly recognized or addressed. Fluoroquinolone antibiotics are not being prescribed in accordance with U.S. FDA guidelines, even though they cause permanent and disabling side effects. We the people know that these dangerous antibiotics will not be immediately discontinued so we are requesting that informed consent be made mandatory for every  fluoroquinolone prescription dispensed in the United States. As this crisis affects people worldwide, the hope is that other countries, regions and territories will follow suit.

Please sign the following petition supporting informed consent on fluoroquinolone antibiotics, to ensure patients know the risks and are able to make an informed decision.   

Details:

Fluoroquinolones are a class of synthetic, systemic antibiotics approved/used to treat and prevent certain bacterial infections.

Fluoroquinolone antibiotics include [5]: 1. Ciprofloxacin (Cipro), 2. Levofloxacin (Levaquin), 3. Moxifloxacin (Avelox), 4. Ofloxacin (Floxin and Ocuflox), 5. Gemifloxacin (Factive), 6. Norfloxacin (Noroxin), 7. Delafloxacin (Baxdela).  
In 2022, there were 44 prescriptions of fluoroquinolones per 1,000 population (USA). There were 14.8 million total fluoroquinolone prescriptions dispensed in 2022 (USA). These statistics do not include dispensary in hospitals, nursing homes, urgent care, or surgical centers [1]. 

While the therapeutic efficacy of fluoroquinolones is clearly recognized and they are valuable for severe life-threatening infections, they are accompanied by a distinct spectrum of adverse effects, flagged by the FDA which can manifest collectively as severe conditions, usually resembling a syndrome in its clinical presentation. Fluoroquinolone Toxicity Syndrome (named by the FDA) represents those suffering from the adverse effects of fluoroquinolone antibiotics. In this situation, patients colloquially refer to themselves as being “Floxed.” People harmed by these antibiotics (“floxed”) are currently unable to receive an accurate diagnosis, effective treatment, or insurance coverage, as a consequence, not able to receive the medical care that they need. The impact of these drugs have caused people to lose employment, their homes and/or become unable to perform daily living activities and thus, disabled. In some extreme cases, people have also lost their lives.

As per the FDA’s report (Occurrence of Adverse Events - Open FDA Reporting 2004-2023), fluoroquinolones have the most adverse events of any other drug on the market. Additionally, 87% of these adverse reactions resulted in a life-threatening condition, hospitalization, disability, congenital anomaly, other serious conditions, or death. Fluoroquinolone adverse events occur 4 times more than Corticosteroids, the second highest drug class on the list [2]. Additionally, in 2015, the FDA released a “Percentage of Disability Reports, for oral dosage forms” (from November 1, 1997 - May 30, 2005), that listed antibiotics with serious outcome reports; fluoroquinolones took the top 5 spots at 31.1% to 9.9% [7]. 

As a result of these dangerous effects, fluoroquinolone antibiotics received a series of Black Box Warnings. In 2008, the FDA released the first Warning for tendons and tendon ruptures. As the years progressed, and more people were harmed by this class of antibiotics, additional Black Box Warnings were issued, including the introduction of Fluoroquinolone Associated Disability (FQAD) by the FDA in 2015. Further Black Box Warnings were released for the worsening of Myasthenia Gravis (2011), potentially irreversible peripheral neuropathy (2013), permanent and disabling side effects (2016), blood glucose disturbances (2018), psychiatric effects (2018), aorta tears and ruptures (2018) [5]. 

FDA guidelines state that due to the, serious side effects associated with these  antibacterial drugs, “fluoroquinolones should be reserved for those who do not have alternative treatment options” [4]. Fluoroquinolones when used systemically (i.e. tablets, capsules, and injectable) 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” [6].

The FDA evaluated reports of apparently healthy patients who experienced disabling and potentially permanent side effects involving two or more body systems after being treated with a systemic fluoroquinolone. “We evaluated only reports submitted to the FDA; there are likely additional cases of which we are unaware. The side effects occurred within hours to weeks after starting the fluoroquinolone. At the time we received the reports the side effects had continued for an average of 14 months, to as long as 9 years, after stopping the medicines. Several cases reported that some side effects stopped or improved after discontinuation of the medicine; others reported that side effects worsened or continued” [6].

It is impossible to know exactly how many people are adversely affected by fluoroquinolones. The FDA Adverse Event Reporting System (FAERS) Public Dashboard is a way to gather this data, but it has serious limitations. Most importantly, the FDA uses a self-reporting system and many people are likely too sick or unaware of the system to report their adverse reactions. Other issues include: 1. duplicate and incomplete reports, 2. existence of a report is unable to establish causation, 3. information in reports has not been verified and 4. rates of occurrence cannot be established with reports [3]. Thus, it is likely that the number of people suffering from fluoroquinolone adverse effects is higher than any estimate. 

FDA guidelines are not being properly followed and many doctors are still prescribing fluoroquinolone antibiotics as first line, resulting in permanent harm and life changing side effects. As a result, these individuals are living a life of chronic illness and/or disability, without any resolution or recourse. No one is being held accountable for not following FDA guidelines and destroying peoples lives. Furthermore, these disabling circumstances could be avoided in most cases, if practitioners adhered to the guidelines or if there was enforcement of these regulations. Many prescribers are either not aware of these warnings and/or disregard them all together, resulting in the refusal to  acknowledge a patient’s report of adverse effects. Practitioners often don’t believe the patient, even though they are reporting the same symptoms that are documented by the FDA and included in the Black Box Warnings. Lastly, the FDA publishes guidelines, which people may or may not read, and then does not enforce them. This is contrary to the FDA’s mission statement, which is to protect the public’s health and safety. 

In conclusion, we are petitioning for a full review and revision of the process for prescribing fluoroquinolone antibiotics. We request that the appropriate governing entities create methods for enforcing FDA guidelines, as well as invoke repercussions for noncompliance. Additionally, we seek  informed consent to be established and made mandatory when prescribing fluoroquinolones. Not a single prescription of this drug class should be dispensed without proper education and sign-off from the patient. If someone is unable to acknowledge their consent for medical reasons, their advance directives, healthcare proxy, next of kin or surrogate, etc. will intervene to decide the appropriate course of treatment. Informed consent will ensure that both patients and providers are aware of the dangers of fluoroquinolone antibiotics and they will have the necessary data to make an informed healthcare decision.

References:

[1] Centers for Disease Control and Prevention (2022). Antibiotic Use & Stewardship. Available at: https://arpsp.cdc.gov/profile/antibiotic-use/fluoroquinolones

[2] Events - Open FDA Reporting, 2004-present Events - https://open.fda.gov/apis/drug/event/explore-the-api-with-an-interactive-chart/

[3] FDA. (2023, December 7). FDA Adverse Event Reporting System (FAERS) public dashboard. U.S. Food and Drug Administration. https://www.fda.gov/drugs/questions-and-answers-fdas-adverse-event-reporting-system-faers/fda-adverse-event-reporting-system-faers-public-dashboard

[4] FDA. (2016, May 12). FDA advises restricting use of fluoroquinolones for certain infections. U.S. Food and Drug Administration. https://www.fda.gov/drugs/drug-safety-and-availability/fda-drug-safety-communication-fda-advises-restricting-fluoroquinolone-antibiotic-use-certain

[5] FDA. (2018, July 18). FDA updates warnings for fluoroquinolone antibiotics on risks of mental health and low blood sugar adverse reactions. U.S. Food and Drug Administration. https://www.fda.gov/news-events/press-announcements/fda-updates-warnings-fluoroquinolone-antibiotics-risks-mental-health-and-low-blood-sugar-adverse#:~:text=FDA%2Dapproved%20fluoroquinolones%20include%20levofloxacin,more%20than%2060%20generic%20versions 

[6] FDA. (2016, July 26). FDA updates warnings for oral and injectable fluoroquinolone. U.S. Food and Drug Administration. https://www.fda.gov/drugs/drug-safety-and-availability/fda-drug-safety-communication-fda-updates-warnings-oral-and-injectable-fluoroquinolone-antibiotics  

 [7] FDA (2017) Fluoroquinolone safety labeling changes - U.S. Food and Drug Administration, FDA/DER Drug Information Webinar . Available at: https://www.fda.gov/media/104060/download