“There seems to be a growing interest in a drug called ivermectin for the treatment of humans with COVID-19. Ivermectin is widely used in the United States to treat or prevent parasites in animals. The FDA has received several reports of patients requiring medical attention and being hospitalized after self-medication with ivermectin intended for horses, ”the agency said in a statement on Friday.
The announcement noted that the FDA has not approved ivermectin for the treatment or prevention of Covid-19 in humans, and the drug is not an antiviral drug.
“Taking large doses of this drug is dangerous and can cause serious harm,” the statement said, noting that even levels of ivermectin approved for other uses can interact with other drugs, such as blood-thinning drugs.
“You can also overdose on ivermectin, which can cause nausea, vomiting, diarrhea, hypotension (low blood pressure), allergic reactions (itching and hives), dizziness, ataxia (balance problems), seizures, coma and even death.”
In the JAMA study in Cali, Colombia, nearly 500 adults with mild illness who had symptoms for seven days volunteered to help test the drug. The lawsuit is what is known as a double-blind randomized trial, the gold standard of trial.
Half of the volunteers received the drug for five days, the other half received placebo and standard care. Patients were enrolled in the trial between July 2020 and November 2020, and physicians followed up with them through December.
At the end of the trial, there were almost as many side effects – mostly headaches – in both groups of volunteers. The patients who received the drug said that their symptoms decreased by 10 days. For the group receiving placebo, it was 12 days.
Two days was not considered a “significant” improvement.
“The results do not support the use of ivermectin to treat mild COVID-19,” the Colombian-based researchers wrote. The study adds that larger trials may be needed to better understand whether ivermectin provides any other benefit to patients with Covid-19. In this case, the study focused on symptoms and mild illness.