What are the FDA and WHO statements on ivermectin use for COVID‑19?
Executive summary
The World Health Organization (WHO) recommends against using ivermectin to prevent or treat COVID‑19 except within clinical trials, citing lack of evidence for benefit and concerns about safety [1]. The U.S. Food and Drug Administration (FDA) has consistently warned the public not to use ivermectin for COVID‑19 outside of research settings, while also defending that its public posts were recommendations rather than binding orders — a distinction that has been litigated and led to removal of some online posts under a court settlement [1] [2] [3].
1. WHO: “Not for COVID‑19 outside trials” — what the agency actually said
The WHO’s formal advisory states that ivermectin should not be used to prevent or treat COVID‑19 except in the context of randomized clinical trials, noting that ivermectin’s approved uses are for parasitic infections like onchocerciasis, strongyloidiasis and scabies, and that current data do not support its routine use for COVID‑19 [1]. That recommendation — framed as a precautionary, evidence‑based stance — reflects WHO’s judgment that the aggregate clinical-trial evidence and safety data are insufficient to justify broad adoption for COVID‑19 outside research settings [1].
2. FDA: “Do not use” messaging, approvals, and the legal aftermath
The FDA has long communicated that ivermectin tablets are approved for specific parasitic infections in humans but are not authorized or approved to treat COVID‑19, and it has advised people not to take ivermectin intended for animals (the veterinary formulations) to treat or prevent COVID‑19 [1] [4]. Agency posts and consumer-facing warnings — including memorable social posts that discouraged use — were described by FDA attorneys in litigation as non‑binding recommendations, not directives, a characterization seized upon by critics and defendants in court [5] [3]. After a lawsuit by physicians, the FDA and HHS agreed to remove certain social‑media posts and a web page warning against ivermectin use within a court settlement, even as the FDA reiterated its view that available clinical-trial data do not demonstrate efficacy against COVID‑19 [2].
3. Evidence and industry voices cited by regulators
Regulators including WHO, the FDA, and the European Medicines Agency pointed to a lack of robust, consistent evidence that ivermectin prevents or treats COVID‑19; Merck, the manufacturer, likewise stated that available studies do not provide meaningful evidence of clinical efficacy and expressed concern about safety data in many studies [1]. The core regulatory message has been that while ivermectin has legitimate, approved uses, the risk–benefit calculus for COVID‑19 remains unsettled and unresolved except under controlled clinical trial conditions [1].
4. The counterargument: physicians, off‑label practice and claims of interference
A contingent of clinicians and some advocates argued that ivermectin should be available off‑label for COVID‑19 and sued the FDA alleging that the agency’s communications unlawfully interfered with medical practice; appellate rulings allowed parts of these suits to proceed, and plaintiffs claimed FDA messaging caused denials of access to treatment [6] [7]. Those physicians contend that warnings were overbroad and harmed patient care, while fact‑checking outlets and public‑health organizations counter that the FDA’s stance remained consistent and rooted in evidence review, and that the agency’s statements were recommendations about safety and efficacy rather than mandates [3] [8].
5. What this means in practice and limits of available reporting
The practical takeaway from WHO and FDA communications is clear: neither organization endorses ivermectin as a routine treatment or preventive for COVID‑19 outside clinical trials — WHO explicitly recommends use only in trials, and the FDA has repeatedly warned against self‑medication and veterinary‑product misuse while defending its guidance as advisory [1] [4] [3]. Reporting shows legal and political disputes about messaging and access, but available sources do not resolve clinical efficacy beyond these regulatory positions; recent litigation led to removal of some postings, yet regulators continue to state that trial data do not demonstrate ivermectin’s effectiveness for COVID‑19 [2] [3]. If assessing patient care options, primary clinical guidelines and peer‑reviewed trial meta‑analyses beyond the scope of these sources should be consulted.