Comment from Anonymous

The FDA should make hydroxychloroquine available over the counter. Patients should not need permission from the government to access safe medications. Doctors should be free to treat their patients. Medical decisions belong in the hands of physicians and individuals 1. Background on Hydroxychloroquine (Approved Uses and Safety) Hydroxychloroquine (HCQ) is a 4-aminoquinoline antimalarial and immunomodulatory drug that has been used in medical practice for decades. It was first approved in the United States in 1955 and is indicated for: (a) prophylaxis and treatment of malaria caused by susceptible Plasmodium species; (b) treatment of chronic discoid and systemic lupus erythematosus; and (c) treatment of rheumatoid arthritis. HCQ is on the World Health Organization’s List of Essential Medicines, reflecting its importance and established role in therapy. In its approved uses, HCQ is generally regarded as safe when used at recommended dosages under routine monitoring, not requiring cardiac monitoring. For decades the FAERS database has listed HCQ as one of the safest medications sold in the USA and consistent with that fact, it is over the counter in much of the world. Common side effects (e.g. gastrointestinal upset, headache, mild transient visual disturbances) are usually self-limited. More serious adverse reactions (retinal toxicity with long-term use, rare idiosyncratic cardiomyopathy or arrhythmias, severe hypoglycemia, etc.) are well-documented but occur infrequently and primarily in the context of prolonged high-dose therapy or specific patient risk factors. Notably, retinal toxicity is a concern mainly for chronic HCQ use well beyond 5 years or at high cumulative doses, and standard medical practice includes periodic ophthalmologic exams for patients on long-term HCQ. The proposed OTC use of HCQ (for short-term COVID-19 prophylaxis or treatment, or intermittent malaria prevention) inherently limits the duration of unsupervised use, thereby substantially mitigating the risk of retinal harm. Cardiac arrhythmias associated with HCQ are exceedingly rare at prophylactic doses and typically involve either intravenous use or drug interactions/overdose; in the OTC setting, we address this by clear warnings against use in individuals with certain pre-existing cardiac conditions or with concomitant medications (see Proposed Labeling in Section 5). HCQ’s safety in special populations is also well characterized. For example, it is considered one of the few disease-modifying anti-rheumatic drugs safe to continue during pregnancy in lupus patients, with studies showing no increase in fetal toxicity or adverse pregnancy outcomes from HCQ use.1 This accumulated safety knowledge, spanning decades of prescription use, provides a strong foundation that HCQ can be used responsibly in a nonprescription setting with appropriate labeling to guide consumers. In summary, HCQ has a long-established safety profile, a wide therapeutic index at the doses relevant to malaria prophylaxis and outpatient therapy, and clear, well-known contraindications