The state government revised its COVID-19 case management protocol on Friday, taking the much-debated drug Ivermectin off the list. The Health department had earlier prescribed the drug for three days.
According to official sources, the drug was taken off the list as a few members of the expert committee objected to its use. Earlier this week, Chief Scientist of World Health Organization (WHO) Soumya Swaminathan had posted on Twitter that safety and efficacy were important when using any drug for a new indication. The WHO opposed the use of Ivermectin for COVID-19, except within clinical trials, she said.
The COVID-19 case management protocol was issued for managing patients at all health facilities other than medical college hospitals/government hospitals/dedicated COVID-19 hospitals.
Ivermectin, used to treat a number of tropical diseases may be recommended for use in COVID-19 patients only in the absence of better treatment options under close monitoring and medical supervision.
The effectiveness of Ivermectin is being investigated in a number of clinical trials across the world due to its potential anti-inflammatory properties and in-vitro activity against COVID-19 virus.
However, “till date, due to the paucity of large clinical trials, the data available is not sufficient enough to recommend the use of Ivermectin for the treatment of COVID-19 emphatically at this point of time”, explained Dr. Wasim Ghori, Mumbai- based Consultant Physician & Diabetologist and Fellow – Royal Society of Public Health, UK.
Dr. Ghori said, Well-designed and large clinical trials are needed to provide evidence-based recommendations on the use of the drug in the management of Covid-19. For stating it to be an absolute drug of choice, we need more trials.
“As Indian scientists weigh the pros and cons, their international counterparts at agencies like the WHO, European Medical Agency (EMA) and USFDA have raised red flags against the use of Ivermectin in the management of Covid-19 patients”, explained Dr. Wasim Ghori.
Merck, the German manufacturer of the drug, has also said available data does not support using the drug as a treatment for COVID-19.
Contrary to what WHO says, Ivermectin is still listed as an option for possible treatment for mild to moderate COVID-19 patients. Recommended by WHO, only for clinical trials, the widespread use of this drug is raising an alarm. Supporting international warnings, Dr. Wasim Ghori disagrees with the widespread use of Ivermectin in patients of Covid-19 unless monitored closely, said Dr. Ghori.
Though the pandemic has forced doctors to adopt the unconventional route of treatment, taking an under-trial drug without medical supervision can be very dangerous, he warned.
Dr. Ghori said there are side effects associated with the drug as listed by the USFDA. “…if it is not taken under proper medical supervision, the side effects may include nausea, sudden drop in blood pressure, skin rash, vomiting, diarrhoea, stomach pain, facial or limb swelling, neurologic adverse events and liver injury.”
However, he adds, that in the current pandemic, the pros are much more than cons in selecting Ivermectin for patients with mild to moderate diseases with symptoms, using it to prevent progression and making a better prognosis.
Till now, we have not seen major side effects. Furthermore, in the absence of other effective medicines and until we get an absolute treatment for Covid-19 or we have surplus amount of Remdesivir to cover patients, there could possibly be some benefits as the disease severity in many cases appears to be less with Ivermectin, said Dr. Ghori.