"There seems to be a growing interest during a drug called ivermectin to treat humans with COVID-19. Ivermectin is usually utilized in the U.S. to treat or prevent parasites in animals. The FDA has received multiple reports of patients who have required medical support and been hospitalized after self-medicating with ivermectin intended for horses," the agency's announcement said on Friday.
The announcement noted that the FDA has not approved ivermectin to treat or prevent Covid-19 in humans and therefore the drug isn't an anti-viral medication.
"Taking large doses of this drug is dangerous and may cause serious harm," the announcement said, noting that even levels of ivermectin approved for other uses can interact with other medications, like blood thinners.
"You also can overdose on ivermectin, which may cause nausea, vomiting, diarrhea, hypotension (low blood pressure), allergies (itching and hives), dizziness, ataxia (problems with balance), seizures, coma, and even death."
The announcement comes just each day after new research published within the medical journal JAMA that found ivermectin didn't seem to "significantly improve" the time needed for symptoms to urge better among patients with Covid-19.
In January, the National Institutes of Health's Treatment Guidelines Panel said that there's not enough data to recommend for or against the drug to treat Covid-19 patients.
The drug may be a cheap medication with anti-inflammatory properties and it appeared to stop the virus from replicating in lab studies -- but more research is required to work out how the drug performs against Covid-19 in the real world.
In the JAMA study based in Cali, Colombia, nearly 500 adults with mild disease who had symptoms for seven days, volunteered to assist test the drug. The trial is what's referred to as a double-blind randomized control trial, the gold standard of trials.
Half the volunteers received the drug for five days, the opposite half got a placebo and standard care. Patients were enrolled within the trial between July 2020 and November 2020 and doctors followed up with them through December.
At the top of the trial, there has been an almost equal number of adverse events -- mostly headache -- in both groups of volunteers. The patients who got the drug said their symptoms subsided by 10 days. For the group that got the placebo, it had been 12 days.
Two days wasn't considered a "significant" improvement.
"The findings don't support the utilization of ivermectin for treatment of mild COVID-19," wrote the researchers, based in Colombia. The study adds that larger trials could also be needed to raised understand if ivermectin provides the other quite beneficial to patients with Covid-19. during this case, the study focused on symptoms and mild disease.
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