FDA Citizen Petition Filed — FDA-2026-P-5116
UPDATE: CITIZEN PETITION IS NOW LIVE AND OPEN FOR COMMENTS "Request that the FDA issue appropriate labeling and risk communication requirements for systemic fluoroquinolone antibiotics"
https://www.regulations.gov/docket/FDA-2026-P-5116/document
I wanted to share something important with this community because many of you have unknowingly helped shape it through your stories, discussions, and willingness to share experiences.
I recently submitted a formal FDA Citizen Petition regarding fluoroquinolone-associated disability (FQAD), drug-induced mitochondrial dysfunction (DIMD), and the need for informed consent and modernization of pharmacovigilance frameworks surrounding delayed, multisystem medication injury such as FQAD.
Today I received confirmation that the petition was officially received and assigned a federal docket number: FDA-2026-P-5116
For those unfamiliar, a Citizen Petition is a formal process that allows individuals or organizations to ask the FDA to review or consider regulatory, safety, labeling, or policy concerns. It does not mean the FDA has made a decision or endorsed the petition, but it does mean the issue formally enters the administrative review process and becomes part of the federal record.
Once publicly posted to the federal docket system, the petition and supporting documents will also become viewable for public comment. This is one of the few formal ways everyday people like us can bring our real-world experiences and perspectives straight to the FDA. If enough of us show up with thoughtful comments, it can help highlight the urgent need for better informed consent and real change around fluoroquinolone antibiotics. Over the years, public advocacy, patient reporting, and formal petitions have contributed to previous regulations and black box warnings.
An FDA Citizen Petition is not a “vote” or signature based petition. It is a formal federal administrative process established under FDA regulations that allows individuals or organizations to request review of regulatory, safety, labeling, or policy concerns.
Unlike change.org-style petitions, a Citizen Petition:
- receives an official FDA docket number,
- becomes part of the federal administrative record,
- can include scientific literature, regulatory arguments, and supporting documentation,
- and may receive public comments that also become part of the official record.
The FDA is required to review and formally respond to the petition, although that process can take significant time and does not guarantee a particular outcome. I have also requested a formal FDA meeting or listening session regarding the petition.
A public/open-access copy of the petition and supporting document can currently be read here: https://doi.org/10.5281/zenodo.20128765
My goal is not to create fear around medications or assign blame. It is to encourage better recognition, better risk communication, more research, and more modern pharmacovigilance approaches that reflect current understanding of mitochondrial biology and delayed injury patterns.
Thank you all again for the support, conversations, scientific discussion, and courage to share your experiences.
— Johanna Ihli, BSN
Former ER/Trauma/Critical Care Nurse
Independent Researcher in Drug-Induced Mitochondrial Dysfunction