South African doctors may now prescribe ivermectin for the treatment of COVID-19 without fear of reprisal or waiting for approval from the South African Health Products Regulatory Authority (SAPHRA), according to a court order on April 6, as the World Health Organization (WHO) advised that the drug be used in a trial only.
The court order ruled that a medical product for human use containing ivermectin “as an active ingredient” had been registered by SAPHRA on March 16, that allowed ivermectin to be compounded, or mixed together with other registered medicines, and “made accessible in accordance with the provisions of Section 14(4) of the Act.”
AfriForum was one of four groups that filed a lawsuit against SAPHRA.
Prior to the ruling, doctors were required to apply for approval for the use of ivermectin through SAPHRA’s controlled compassionate use program under Section 21 of the Medicines and Related Substances Act, which allowed SAPHRA to sell an unregistered medical product within the country.
But submitting an application did not guarantee approval from the medical regulator.
WHO Recommends Against Ivermectin Use
The WHO said its decision was based on the review of 16 randomized controlled studies with 2407 participants by its panel of experts assessing whether ivermectin had any impact on hospital admission, viral clearance, mortality, and mechanical ventilation.
Dr. Pierre Kory, a member of the Front Line COVID-19 Critical Care (FLCCC) Alliance, said that the WHO’s statement was not based on “science” and was rather biased.
Kory also said that the WHO’s recommendation was in-line with statements from the National Institutes of Health (NIH), the European Medicines Agency (EMA), and Merck, to try to “manufacture uncertainty about science where little or none exists.”
The WHO didn't respond to a request for comment.
“There are insufficient data for the COVID-19 Treatment Guidelines Panel (the Panel) to recommend either for or against the use of ivermectin for the treatment of COVID-19,” the NIH stated.
“We do not believe that the data available support the safety and efficacy of ivermectin beyond the doses and populations indicated in the regulatory agency-approved prescribing information,” Merck said.
“Despite the encouraging trend this existing database demonstrates,” the researchers say that “additional, higher-quality and larger-scale clinical trials” are needed before “regulatory approval of ivermectin.”
Dr. Jean-Jacques Rajter, a pulmonologist who treated severe COVID-19 patients successfully with ivermectin early on in the pandemic, testified at a Senate hearing last December that funding and support for a randomized controlled trial to confirm ivermectin’s efficacy and safety had been difficult.
IvermectinIvermectin, an inexpensive anti-parasitic drug initially given to animals, was approved for human use in 1987 for the treatment of onchocerciasis, or river blindness, a disease caused by worms that were transmitted by flies. More than 3.7 billion doses of ivermectin have been distributed in over 30 years.
The drug is on the WHO’s essential medicines list and has a high safety profile.
Some common side effects of ivermectin include nausea, diarrhea, dizziness, and skin rash, according to the FDA.
Countries Using Ivermectin
Ivermectin for animals is not recommended for human consumption as “animal drugs are often highly concentrated” and “can be highly toxic in humans,” according to the FDA.