Warning against Ivermectin to treat COVID-19
19 January 2021
SAHPRA said it was not yet possible to recommend Ivermectin as a COVID-19 drug.
Scientists, authorities and most notably, the Food and Drug Administration (FDA) in the United States of America have warned against taking an anti-parasite drug as a treatment for COVID-19, despite headlines, WhatsApp chain messages and posts on social media that have touted it as a cure. Facebook posts and articles endorsing Ivermectin have proliferated in Brazil, France, South Africa and South Korea as governments around the world scramble to roll out vaccination programmes. However, citizens are cautioned against taking the drug. A myriad of health agencies have stated that there is not enough evidence to promote the drug as a remedy for COVID-19, and that research into the question has often been unsound. Authorities are clamping down on the dispensing of Ivermectin, which is being marketed as a COVID-19 “miracle drug”, and concern that an underground market may soon emerge is very real. The South African Health Products Regulatory Authority (SAHPRA) has warned the public against using the drug to treat COVID-19, as it has not been approved for use in humans.
Ivermectin is a widely used drug for the treatment and control of parasites in animals, and is used to treat several tropical diseases in humans not commonly seen in South Africa, as well as scabies and head lice. In South Africa, Ivermectin is registered for use under Act 36 of 1947 (Department of Agriculture) for use in animals. This means that veterinarians and other trained personnel are allowed to prescribe it as an anti-parasitic agent for a variety of animals. The drug is not currently registered for human use, but SAHPRA occasionally grants Section 21 permits for the use of topical Ivermectin as an unregistered product for the treatment of individual patients with conditions such as scabies or head lice. Researchers stated that flawed studies backing the drug have stoked black market sales, hampered further scientific research and swayed government responses to the pandemic.
“The policy decisions of Ivermectin in Latin America have been largely based on the analysis presented in a pre-print in early April,” experts at the Barcelona Institute for Global Health said.
A pre-print typically means a study that has been put on the internet but not undergone peer review, the process by which findings are scrutinized by other scientists before they are published in a scholarly journal.
The paper was later retracted after experts raised methodological concerns. Ivermectin is one of a string of medications tested as a potential COVID-19 treatment since the pandemic began, and there is currently no sound evidence that it is effective and safe to use. Much like the anti-malaria drug hydroxychloroquine, which is also so far unproven by clinical trials, Ivermectin is widely available and relatively cheap. The FDA has also thrown its weight beind the caution against Ivermectin, and stated that drug had not been approved to prevent or treat COVID-19. “While there are approved uses for Ivermectin in people and animals, it is not approved for the prevention or treatment of COVID-19," it stated. A widely-cited study published in April in the Antiviral Research medical journal found that Ivermectin was effective against SARS-CoV-2, the virus that causes COVID-19, in cells tested in a lab dish. However, the findings have been misconstrued by the public, as drugs that give promising results in a laboratory setting are frequently ineffective in humans, often because the dose required to neutralize a pathogen cannot safely be administered to patients. SAHPRA said it was not yet possible to recommend Ivermectin as a COVID-19 drug.
“From the available randomized control trial evidence, Ivermectin is not superior to placebo in terms of viral load reduction or clinical progression. There is no evidence from randomized control trials for any reduction in mortality,” it said in a statement. “Some of the side-effects that may be associated with Ivermectin include skin rash, nausea, vomiting, diarrhea, stomach pain, facial or limb swelling, neurologic adverse events (dizziness, seizures, confusion), sudden drop in blood pressure, severe skin rash potentially requiring hospitalization and liver injury (hepatitis). Laboratory test abnormalities include decrease in white cell count and elevated liver tests. Any use of Ivermectin for the prevention or treatment of COVID-19 should be avoided as its benefits and safety for these purposes have not been established. Data from clinical trials are necessary for us to determine whether Ivermectin is safe and effective in treating or preventing COVID-19.”