FDA MedWatch - Why You Should Not Use Ivermectin to Treat or Prevent COVID-19: Consumer Update

MedWatch - The FDA Safety Information and Adverse Event Reporting Program TOPIC: Why You Should Not Use Ivermectin to Treat or Prevent COVID-19: Consumer Update AUDIENCE: Consumer, Health Professional  ISSUE: There seems to be a growing interest in a drug called ivermectin to treat humans with COVID-19. The FDA has not reviewed data to support use of ivermectin in COVID-19 patients to treat or to prevent COVID-19; however, some initial research is underway. Taking a drug for an unapproved use can be very dangerous. The FDA has received multiple reports of patients who have required medical support and been hospitalized after self-medicating with ivermectin intended for horses. Even the levels of ivermectin for approved uses can interact with other medications, like blood-thinners. You can also overdose on ivermectin, which can cause nausea, vomiting, diarrhea, hypotension (low blood pressure), allergic reactions (itching and hives), dizziness, ataxia (problems with balance), seizures, coma and even death. For more information about this consumer update, click on the blue button "Read More" below. BACKGROUND: Ivermectin tablets are approved by the FDA to treat people with intestinal strongyloidiasis and onchocerciasis, two conditions caused by parasitic worms. In addition, some topical (on the skin) forms of ivermectin are approved to treat external parasites like head lice and for skin conditions such as rosacea. Some forms of ivermectin are used in animals to prevent heartworm disease and certain internal and external parasites. It's important to note that these products are different from the ones for people, and safe when used as prescribed for animals, only. RECOMMENDATIONS:  FDA has not approved ivermectin for use in treating or preventing COVID-19 in humans. Ivermectin is not an anti-viral (a drug for treating viruses). Taking large doses of this drug is dangerous and can cause serious harm. If you have a prescription for ivermectin for an FDA-approved use, get it from a legitimate source and take it exactly as prescribed. Never use medications intended for animals on yourself. Ivermectin preparations for animals are very different from those approved for humans. Effective ways to limit the spread of COVID-19 continue to be to wear your mask, stay at least 6 feet from others who don't live with you, wash hands frequently, and avoid crowds. Health professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program: Complete and submit the report online. Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on form, or submit by fax to 1-800-FDA-0178.

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