The Federal Conversation Has Begun
An FDA Citizen Petition is on record. A manuscript is under peer review. A registry is open. The evidence base is being built — and every voice, every data point, every public comment matters.
The FDA Citizen Petition
This petition does not ask the FDA to ban fluoroquinolones. It asks for something more precise and more achievable: that the informed consent and patient-facing risk communication for systemic fluoroquinolone antibiotics be updated to accurately reflect what the regulatory record — and modern molecular science — already documents. Patients deserve to know, before they take these medications, that delayed, multisystem, and potentially permanent adverse effects are a recognized regulatory reality, not a rare coincidence.
Updated Informed Consent Language
Patient-facing risk communication that accurately describes the possibility of delayed, multisystem, and potentially permanent adverse effects — in language patients can understand before making a treatment decision.
Improved Risk Communication Materials
Medication guides and prescriber communications updated to reflect the 2016 FDA Safety Communication language — "disabling and potentially permanent" — in a format that reaches patients at the point of prescribing.
Recognition of Multisystem Syndrome
Regulatory acknowledgment that the constellation of symptoms described in FQAD represents a coherent multisystem syndrome, not a collection of unrelated individual adverse events.
Restriction Reinforcement for Minor Infections
Reinforcement of the existing 2016 FDA recommendation to avoid fluoroquinolone use for uncomplicated infections when effective alternatives are available — a recommendation that remains inconsistently applied in practice.
There Is a Role for Every Audience
This effort does not belong to any single group. Patients, clinicians, researchers, and policymakers each hold a different piece of what is needed — and each has a distinct way to participate.
Your experience is evidence
- Submit a public comment to FDA docket FDA-2026-P-5116
- Participate in the DIMD Registry — share structured symptom and exposure data
- Share the petition with others who may have been affected
- Ask your clinician to document the exposure-effect relationship in your medical record
Code it. Document it. Report it.
- Use ICD-10-CM fluoroquinolone adverse effect codes when clinically appropriate
- Document exposure-effect relationships in the medical record
- Submit MedWatch reports for delayed or persistent adverse effects
- Submit a professional comment to the FDA docket
- Review the systems-level framework preprint (DOI: 10.5281/zenodo.20015205)
The gaps are documented. Fill them.
- Cite and build on the DIMD mechanistic framework
- Design studies with delayed adverse effect endpoints
- Investigate ATFS-1/POLG-mediated heteroplasmy propagation in human drug-induced injury models
- Submit peer review comments or letters to the FDA docket
What Needs to Change — and Why It Can
Beyond the petition, the DIMD initiative advocates for systemic changes to how drug safety is evaluated, communicated, and tracked. These are not radical asks. They are logical extensions of what modern mitochondrial science already demands.
Mitochondrial Safety Endpoints in Drug Evaluation
Integration of mtDNA copy number, OXPHOS complex activity, and ROS biomarkers into preclinical and post-market safety studies for drug classes with known mitochondrial mechanisms.
Longitudinal Adverse Event Tracking
Pharmacovigilance systems that follow patients over months and years — not just during or immediately after drug exposure — with explicit tracking of delayed and cumulative mitochondrial effects.
National Exposure-Linked Registry
A structured national registry linking drug exposure histories to delayed adverse outcomes — building the longitudinal evidence base that currently does not exist.
Clinician Education on Delayed Mitochondrial Patterns
Integration of mitochondrial pharmacotoxicology into medical education and continuing education — bridging the gap between what molecular biology understands and what clinical practice currently recognizes.
Electronic Health Record Flagging
EHR-level alerts that flag prior fluoroquinolone adverse effect history before a subsequent prescription is written — a basic patient safety mechanism that does not currently exist.
"Modern medicine is simply not yet equipped to routinely recognize and address this. That is not a moral failing — it is a structural one. And structural gaps can be closed."
— DIMD InitiativeThe DIMD framework does not ask anyone to accept blame. It asks the scientific and regulatory community to do what it does best: update its models when the evidence demands it.
Mitochondrial biology has advanced dramatically in the past three decades. Drug safety frameworks were designed before much of this science existed. The ask is simply that they evolve — as all good scientific frameworks do when new evidence arrives.
Evolution, Not Blame
This initiative is not an indictment of any prescriber, any pharmaceutical company, or any regulatory agency. The medications in question were approved on the best available science of their era. The clinicians who prescribed them followed guidelines. The patients who took them trusted their doctors.
The problem is not malice. The problem is that our understanding of mitochondrial biology has advanced enormously in the past thirty years — and our safety models have not fully kept pace. That is a structural and educational gap, and it is one that can be closed through precisely the kind of regulatory, scientific, and clinical engagement this initiative is pursuing.
Assigning fault to prescribers who followed guidelines, pharmaceutical companies who met approval standards, or regulators who acted on available evidence.
Updating the framework. Incorporating what modern mitochondrial science now demands into how drugs are evaluated, labeled, and communicated to patients.
Sensationalizing rare adverse events or creating fear around broadly useful antibiotic classes that have saved millions of lives.
Accurate informed consent. Giving patients the information they need to make real decisions — including knowledge that delayed, multisystem, and permanent effects are a documented regulatory reality.
Every Action Adds to the Record
Comment. Participate. Share. The evidence base for DIMD recognition is being built in real time — and every piece of it matters.
How to Submit a Public Comment
The FDA docket is open for public comment on regulations.gov. Public comments become part of the official administrative record and are considered by the FDA in its review of the petition. Your comment matters — whether you are a patient, clinician, researcher, or concerned member of the public.
You do not need special credentials to submit a comment. You do not need to be a scientist or a lawyer. What the record needs is voices — specific, substantive, and grounded in real experience or professional knowledge.
Open the FDA docket
Click the direct docket link below. On the Regulations.gov page, select the comment option for docket FDA-2026-P-5116 and submit your comment. Open FDA Docket FDA-2026-P-5116 →
Click "Comment" on the Docket
Open the docket page and click the green "Comment" button to begin your submission. No account is required.
Write Your Comment
Be specific. Describe your experience, your professional perspective, or your concern. Concrete and personal comments carry more weight than general statements.
Submit and Receive Confirmation
Submit your comment and save your confirmation number. Your comment is now part of the official FDA administrative record.
Guidance for Effective Comments
"The federal conversation has begun. Public comments are how the record grows from one voice to many."