EU Petition 2026

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EU-Petition

Appendix: Factsheet

Petition to the European Parliament

Article 35 - Charta of the European Union. Health Protection

Everyone has the right of access to preventive health care and the right to benefit from medical treatment under the conditions established by national laws and practices. A high level of human health protection shall be ensured in the definition and implementation of all Union policies and activities.

22 April 2026

Dear Members of the European Parliament,

we are an independent working group and initiative dedicated to raising awareness about the risks of fluoroquinolone antibiotics and advocating in the interest of patients harmed by this medication. Our goal is to achieve full recognition of this complex multi-systemic disease known under the term 'Fluoroquinolone-Associated Disability' (FQAD), to establish a separate primary ICD diagnostic code and to ensure the best possible medical care for those affected. Many of us have been affected by it personally and are well aware of possible fatal consequences of Fluoroquinolone (FC-) Toxicity. There are far more than just “rare” cases of people harmed by FC, as is often claimed.

Regarding the dangers of quinoline and fluoroquinolone antibiotics, a public Hearing was conducted on a European level on 13 June 2018 by the EMA. Both those affected and experts had their say. We are familiar with the Hearing and the Summary.

www.ema.europa.eu/en/documents/other/public-hearing-quinolone-and-fluoroquinolone-written-interventions_en.pdf

Eight years have now passed. More studies on FC antibiotics were done, more facts about FC toxicity have come to light, more human tragedies worldwide have been reported. We hear of new cases almost every day. We wonder whether the EMA and the Pharmacovigilance Risk Assessment Committee (PRAC) are aware of all this. We wonder what action they are taking to prevent further damage, and to help those affected who require the best possible medical and social support.

This is why we turn to you today.

We would like to get answers to questions such as:

Is the EMA aware of recent studies, estimated numbers of affected people including people who chose suicide out of sheer desperation and pain? Are you, members of the European Parliament, aware of it?
Is there any research on the toxicity of fluoroquinolone commissioned or supported by the European Parliament/EMA? If so, we would like to know more about it.
We know the “Study of impact of EU label changes for fluoroquinolone containing medicinal products for systemic and inhalation use - post-reerral prescribing trends” from 2020 updated on 2024. Study 2020/2024 | EUPAS37856 | 48010. Our question is: Is this the final answer so far to the problem raised with the Hearing on 13 June 2018?

The EMA, the American FDA, and the Federal Institute for Drugs and Medical Devices (BfArM) in Germany have repeatedly warned of serious, sometimes irreversible side effects. The German BfArM has issued eight official warnings regarding fluoroquinolones to date, while the FDA has issued seven. As early as 2018/2019 EMA referred to “potentially serious, long-term and irreversible damage” across Europe.
Warning: www.ema.europa.eu/de/documents/referral/quinolone-and-fluoroquinolone-article-31-referral-disabling-and-potentially-permanent-side-effects-lead-suspension-or-restrictions-quinolone-and-fluoroquinolone-antibiotics_de.pdf

Nevertheless, to this day, all EU countries lack a primary ICD code and thus the very basis for providing medical care to patients and for recognizing their condition.

In Germany, general practitioner Dr. Stefan Pieper can be regarded as the pioneer of raising awareness to FQAD. He is the first doctor who tried to help affected patients, started to research on the problem, connected with the few colleagues all over the world who are aware of FQAD and, in 2020, published the book “Fluoroquinolone-Associated Disability FQAD: Pathogenese, Diagnostik, Therapie und Diagnosekriterien: Nebenwirkungen von Fluorchinolonen”.
Book: www.praxisdrpieper.de/fqad/

In 2024, Dr. Stefan Pieper submitted a proposal to introduce an ICD code for FQAD in Germany. However, this was rejected by the BfArM – even though the relevant safety authorities have been aware of the significant potential for harm posed by fluoroquinolones for years. In the U.S., a separate primary ICD-10 code for fluoroquinolone-related harm was introduced in October 2025.

As a result of our initiative, two additional applications were submitted to the BfArM in February 2025, and on January 1, 2026, the Secondary code Y57.90! was introduced. However, it is a so-called “call-out code” that must be 'attached' to existing primary diagnoses and has no relevance on its own. This means that those affected not only fail to receive targeted medical care but also receive no social security recognition (e.g. severe disability benefits, rehabilitation or pension benefits) and fall into social marginalization. klassifikationen.bfarm.de/icd-10-gm/kode-suche/htmlgm2026/block-y40-y84.htm

In the year of the EMA Hearing in 2018, the Scientific Institute of the German Health Insurance Company AOK “WIdO” estimated that in 2018 alone, at least 40,000 people were harmed by fluoroquinolone antibiotics in Germany. This estimate only referred to a limited selection of serious diagnoses, such as damage to the nervous system, ruptured tendons, and aortic damage. This figure does not include the large number of patients with serious illnesses who go undiagnosed or misdagnosed due to a huge and inexcusable lack of knowledge among doctors. www.wido.de/fileadmin/Dateien/Dokumente/Forschung_Projekte/Arzneimittel/wido_arz_fluorchinolone_0519.pdf

The estimate of WIdO is in stark contrast to the PRAC's estimate from the same year, which projected around 3,000 cases a year across the whole of the EU!

www.bfarm.de/DE/Arzneimittel/Pharmakovigilanz/Themendossiers/Fluorchinolone/Fluorchinolone_FAQ.html

There are further estimates, like that of Charles Bennett, which is based on reports of side effects from the United States extrapolated to German conditions. Bennett suggests that approximately 40,000 to 400,000 people are affected each year in Germany. www.myquinstory.info/dr-charles-bennett-to-speak-about-fluoroquinolones-at-pharmedouts-june-2015-conference/

To make a long story short: Fluoroquinolones continue to be used extensively even outside their intended indications, while at the same time new data is continually being published that demonstrates both the severity and the extent of the harm caused by this class of drugs.

Against this backdrop of growing evidence of the dangers of fluoroquinolones, staggering numbers of victims and continued careless prescribing and use of these drugs, many questions arise for us, particularly the following:

How do the EMA and the European Parliament assess these developments today?
What are you doing to address the apparent disregard for European warnings?

For all these reasons, we are reaching out to you, our European representatives, whose responsibility as regards European citizens’ health is to ensure the safety of medicines, promote scientific research in the medical field, combat threats to public health, and accelerate global cooperation with health authorities such as the FDA in the interest of innovative therapies.

It is time to re-evaluate the dangers of fluoroquinolone!

We kindly ask you to support our cause and Petition. We include a fact-sheet to help you learn more in-depth about the problems that urgently require your attention and action.

We hope to hear from you and will be grateful for your advice and support.

With kindest regards
FQAD Arbeitsgruppe Öffentlichkeitsarbeit

Petitionsnr.: 1043/2026

Appendix: Factsheet

FQAD - Fluoroquinolone Associated Disability
Why a distinctive primary ICD-Code for FQAD is necessary and long overdue.

1 What are Fluoroquinolones?

Fluoroquinolones (gyrase inhibitors), such as ciprofloxacin or levofloxacin, are fully synthetic reserve antibiotics. Their bactericidal effect is based on the inhibition of bacterial DNA gyrase and topoisomerases II and IV. Studies show that they can also impair mitochondrial processes, oxidative stress, and cellular repair mechanisms in humans [1-3] – the same mechanism of action known from chemotherapeutic agents. Despite their efficacy, they can cause serious, multisystemic, and sometimes irreversible side effects, often with a delayed onset and without early warning signs.

2 Multisystemic damage due to Fluoroquinolones

Poisoning caused by fluoroquinolones, also known as FQAD (fluoroquinolone associated disability), affects multiple body systems simultaneously, a pattern not seen to this extent with any other class of antibiotics.

Many patients report more than 40, and in some cases even over 100, different symptoms that fluctuate, occur in episodes, or overlap – over the course of weeks, months, or years. In severe cases, the symptoms and related conditions persist permanently.

The symptoms are multisystemic and include, among others:

the peripheral and central nervous systems
the psyche and the autonomic nervous system
muscles, tendons, and joints
the cardiovascular, gastrointestinal, and ENT systems,
as well as the skin and eyes
and hormonal balance and cellular energy metabolism

These symptoms have been documented, described in official warnings, and recognized by drug regulatory authorities as possible side effects.

Nevertheless, to this day there is no separate, specific ICD code for the multisystem damage caused by fluoroquinolones.

3 The Facts: Clear – but systematically ignored

a. Distribution & Prescription

>3.3 million prescriptions in Germany in 2018 [1]
At least 12 million defined daily doses (DDD) in 2021 – Fluoroquinolones remain among the four most commonly prescribed antibiotics [1]
Despite risk assessments: Prescriptions are often outside the recommended indications [11]
Rising bacterial resistance worldwide due to frequent, indiscriminate prescribing [12]
Increasing resistance due to frequent prescribing and increased use of fluoroquinolones—including in animal husbandry [14]

b. Extent of losses – nationally and extrapolated for those with public health insurance

An estimated >40,000 new cases of serious adverse reactions per year in Germany [1], not including unreported cases

This corresponds to approximately 100 new cases per day
Projected over 42 years (1984-2026):
- > 1.68 million people with public health insurance who may be affected
140 deaths in 2018 caused by fluoroquinolones, according to WidO [1]
- projected: >5.880 deaths since market launch
Enormous economic damage amounting to €3.42 billion annually [11]

c. Regulatory warnings (national/international)

8 Red-Handed-Letters by BfArM (2008- 2026) [2]
7 Black-Box-Warnings by the US-FDA (until 2026) [3]
EMA Risk Report (2018), 80 p.: Long-lasting, potentially irreversible damage” [4]
FDA (2016): The average duration of side effects ranges from 14 months to 9 years, or they may be irreversible [5]
MHRA UK (2025): Use only when there is no alternative [9]
USA (2025): Introduction of a separate primary ICD code for poisoning caused by fluoroquinolones (T36.AX5) [3]
- Germany (2026): Simply the introduction of a secondary code for fluoroquinolone-related harm (Y57.90!) – not a full primary key [15]

d. Scientific findings on mechanisms and multisystemic damage

Angewandte Chemie/ Applied Chemistry (2024): Reinhardt et al.:
- Evidence of oxidative stress and mitochondrial damage caused by fluoroquinolones in humans [6]
- Intrinsic toxicity of fluoroquinolones due to off-target effects resulting from the direct inhibition of two mitochondrial enzymes (AIFM1 & IDH2) [6]
BMC Medicine (2025): Cohort study conducted with BfArM & WIdO
- Documented multisystem damage in previously healthy young patients in Germany [8]
- Increased risk of severe long-term consequences among people aged 18 to 39, 40 to 69, and over 70 [16]
- Mitochondria, nerves, cell repair, and hormonal pathways are affected – clinically proven [1-3]

e. Care Gap & Coding

Symptoms and harm are scientifically documented, described in warning labels, and recognized by regulatory authorities
Nevertheless: There is no official primary ICD code for Fluorquinolone toxicity in Europe

This leaves fluoroquinolone toxicity as the only serious side effect caused by an antibiotic that does not have its own primary code

Affected patients are not properly registered, receive inadequate medical care, and are overlooked under social welfare law

4 Supply Gap: No primary Code – no Help

“Talk to your doctor”– yet many don’t know what FQAD is. The majority of doctors are unaware of the severity, duration, and multisystemic nature of the potential damage. Even when the connection is recognized, scientifically sound treatment options are usually lacking.

Patients who specifically mention fluoroquinolones often encounter ignorance, overwhelm, or disbelief – despite repeated warnings from the EMA, FDA, BfArM, MHRA, and others. Side effects are often not reported.

As long as there is no specific ICD code for FQAD, the condition remains invisible: in doctors’ offices, in hospitals, in studies, in statistics – and in healthcare.

5 Diagnosis is possible

FQAD is documented by international drug regulatory authorities and recognized as a consequence of severe fluoroquinolone side effects. [4,5,8,9] As with many other conditions, FQAD can be diagnosed based on a typical clinical presentation. Systematic assessment is medically sound and feasible, for example by using Dr. Pieper’s FQAD questionnaire. [3]

6 Comparable ICD codes. ICD code for FQAD is missing!

Other classes of antibiotics can also cause side effects—but these are generally reversible, limited to the local area, and have long been included in the ICD-10 coding system.

Fluoroquinolones, on the other hand, cause serious, often irreversible damage to multiple organ systems—and despite eight “red-hand” letters, FQAD remains uncodable to this day.

Petitionsnr.: 1043/2026

To date, FQAD is the only antibiotic-related injury that, despite potentially irreversible consequences, is neither classified nor systematically treated.

7 Why a distinctive primary ICD code is necessary for FQAD

A distinctive primary ICD-Code for FQAD allows:

Systematic diagnosis and documentation
Statistical data collection and targeted research
Appropriate use of Fluoroquinolones
Reducing the workload of doctors through clear assignment of responsibilities
Access to therapies, rehabilitation, medical evaluations, disability rating (GdB), and reduced earning capacity and total disability pensions
Reducing the burden on the healthcare system, e.g., by avoiding unnecessary diagnostic tests and associated costs

Sources:

Schröder H et al. Risikoreiche Verordnungen von Fluorchinolon-Antibiotika. WIdO. 2019. Verfügbar unter: WIdO-Studie [Zugriff am 29.06.2025]
Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM). Rote-Hand-Briefe. 2008-2025. Verfügbar unter: rHB-Suche BfArM [Zugriff am 29.06.2025], rHB Norfloxacin [Zugriff am 29.06.2025]
U.S. Food and Drug Administration (FDA). Drug Safety Communications. 2024. Verfügbar unter: https://www.fda.gov/drugs/drug-safety-and-availability [Zugriff am 29.06.2025]
European Medicines Agency (EMA). Referral PRAC-Bericht und DHPCs. 2018 2023. Verfügbar unter: EMA-PRAC Bericht [Zugriff am 29.06.2025]
FDA Drug Safety Communication: FDA updates warnings for oral and injectable fluoroquinolone antibiotics due to disabling side effects. 2016. Verfügbar unter: FDA Drug Safety Communication [Zugriff am 29.06.2025]
Reinhardt S et al. Chemical proteomics reveals human off‐targets of fluoroquinolone-induced mitochondrial toxicity. Angew Chem Int Ed. 2024;63:e202421424. Verfügbar unter: Studie-Mitochondrienschäden [Zugriff am 29.06.2025]
Golomb BA et al. Fluoroquinolone-induced serious, persistent, multisymptom adverse effects. BMJ Case Rep. 2015 Oct 5;2015. Verfügbar unter: BMJ Case Reports [Zugriff am 29.06.2025]
Schick J et al. High risk for life-threatening adverse events of fluoroquinolones in young adults: a large German population-based cohort study. BMC Medicine. 2025. Verfügbar unter: BMC Medicine [Zugriff am 29.06.2025]
MHRA. Public Assessment Report: Fluoroquinolones. UK Medicines and Healthcare products Regulatory Agency. June 2025. Verfügbar unter: MHRA Report [Zugriff am 29.06.2025]
Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM). Impulsbericht 2023. Bonn: BfArM; 2024. S. 26. Verfügbar unter: BfArM - Jahresberichte [Zugriff am 01.07.2025].
Pieper S. Fluoroquinolone-Associated Disability (FQAD). 2nd ed. Berlin: Springer; 2024, S.1
World Health Organization. Critically important antimicrobials for human medicine: 6th revision. Geneva: WHO; 2019. Verfügbar unter: https://www.who.int/publications/i/item/9789241515528 [Zugriff am 01.07.2025].
Pieper S. Fluoroquinolone-Associated Disability (FQAD). 2nd ed. Berlin: Springer; 2024, S.67-95 22 April 2026 -English Version
Bundesamt für Verbraucherschutz und Lebensmittelsicherheit (BVL). Abgabemengen von Antibiotika in der Tiermedizin: Fluoroquinolone erstmals wieder angestiegen [Internet]. Berlin: BVL; 2024 [zitiert 11. Juli 2025]. Verfügbar unter: bvl-bund
Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM). ICD-10-GM Version 2026: endgültige Fassung veröffentlicht [Internet]. Bonn: BfArM; 2025 [zit. 22. Sept. 2025]. Verfügbar unter: BfArM-ICD-10-GM 2026
J. Wicherski, J. Peltner, C. Becker und B. Haenisch, „IQWiG,“ 25.06. 2025. [Online]. Available: https://www.iqwig.de/veranstaltungen/03_iid-2025_wicherski.pdf