Goa wants all adults to take Ivermectin. Here's why FDA warned against its use
Goa health minister Vishwajit Rane on Monday said that all adults -- everyone above the age of 18 in the state -- will be given the Ivermectin antiparasitic drug irrespective of their coronavirus disease (Covid-19) status. Although the minister claimed that the medicine has been found to bring down the Covid-19 mortality rate in several countries, the United States Food and Drug Administration (FDA) had warned against its use in treating coronavirus patients back in April last year.
Not just the FDA, the Union ministry of health and family welfare had also opted out from including Ivermectin in its official Clinical Management Protocol for Covid-19 last year. Experts of the central government's joint monitoring group and the Indian Council of Medical Research (ICMR)'s Covid-19 task force held a meeting to deliberate upon the issue and decided not to include Ivermectin in the clinical management protocol "because of lack of sufficient evidence on its efficacy based on randomised trials held in India and abroad," news agency PTI reported, citing ministry sources.
What is Ivermectin?
Ivermectin is a medication mainly used to treat various types of parasite infections. According to the FDA, Ivermectin is a veterinary drug, often used in the US to treat or prevent parasites in animals. Ivermectin tablets are approved at very specific doses for some parasitic worms, and there are topical (on the skin) formulations for head lice and skin conditions like rosacea. Still, Ivermectin preparations for animals are very different from those approved for humans.
Ivermectin is not an anti-viral (a drug for treating viruses), as such, but its use in coronavirus disease (Covid-19) treatment is an unconventional application, according to experts.
What have studies found?
A report, published in Antiviral Research in June last year, clearly mentioned that Ivermectin "warrants further investigation for possible benefits in humans". The drug generated widespread excitement in medical and veterinary journals, which incorrectly described it as a treatment or cure for Covid-19, the report said.
Studies showed that doses much higher than the maximum approved or safely achievable limit for use in humans would be required to achieve an antiviral effect. Such high doses have not been approved for human use, since it would actually prove toxic considering the drug is said to operate via the suppression of a host cellular process.
Although a research group in India summarised the results of four small studies on Ivermectin as a treatment for Covid-19 and showed that there was a statistically significant improvement in survival rate among patients, the authors clearly stated that the quality of the evidence was low and further trials are needed to determine its effectiveness.
A systemic review in November last year concluded that there's "weak evidence" of Ivermectin's benefit when used as add-on therapy in non-severe Covid-19 cases. No difference was found in patients who received a placebo and others who received Ivermectin in a randomised controlled trial (RCT) that year.
FDA's warning against Ivermectin
The FDA found it necessary last year to issue a warning against Ivermectin's use in Covid-19 treatment, as the evidence is not solid enough to come to a conclusion based on multiple small-scale studies.
Ivermectin is recommended against in Covid-19 treatment by the FDA, the European Medicines Agency, and the United States National Institutes of Health -- all of which have stated that better studies and larger trials are needed to determine if the drug has any actual benefits.
The World Health Organization (WHO) has also warned against the use of Ivermectin for Covid-19, except within clinical trials. Saumya Swaminathan, the chief scientist at WHO, tweeted out earlier this day, saying "Safety and efficacy are important when using any drug for a new indication."
Dr Swaminathan attached a statement from Merck, the German healthcare corporation, on Ivermectin use during the Covid-19 pandemic.
Directives issued in Goa
The state of Goa, however, is proceeding on the path of providing every adult with Ivermectin, despite the lack of strong evidence advocating its benefits.
Goa health minister Vishwajit Rane said that patients will be given Ivermectin 12mg for a period of five days as expert panels from the UK, Italy, Spain, and Japan have found a statistically significant reduction in mortality, time to recovery, and viral clearance in Covid-19 patients treated with this medicine.
The minister said this treatment would not prevent Covid-19 infection but it can help reduce the severity of the disease.