Johannesburg, Jan 28 (PTI) The South African Health Products Regulatory Authority on Wednesday approved the controlled use of the drug, Ivermectin, despite continuing concerns about its efficacy in the treatment of coronavirus.
The drug is being used to treat livestock but had not been approved for human consumption till now.
The regulatory body’s Chief Executive Officer, Dr Boitumelo Semete-Makokotlela, said in a virtual media briefing on Wednesday that they will allow a “controlled and compassionate programme” for the use of the drug after embarking on extensive engagements with medical professionals.
She said a guideline in this context would be made available soon.
Semete-Makokotlela said a number of factors had led to the decision.
“We are in the second (coronavirus) wave. We are seeing lives being lost and we have many medical practitioners that have reached out to us. We have considered all of that. The approach is that we will facilitate a controlled, compassionate access programme for Ivermectin,” she said, emphasising that the authority has not changed its stance on the efficacy of the drug for coronavirus treatment.
“Our position has not changed around the availability or lack of availability of data but we had to have in-depth discussions around the context.
“We are in a pandemic with limited options available. It is on that basis that we are saying we will facilitate a controlled access programme,” she said. Commenting on the pleas from doctors to allow the use of Ivermectin, Semete-Makokotlela said the authority understood the position from which the health practitioners were coming.
“We also understand the pressure healthcare practitioners are facing because of these limited options. We also acknowledge that there are very limited but good evidence-based options that exist,” Semete-Makokotlela said.
“Although we now have good evidence for hospitalised patients, we’d like more. We are very supportive of our healthcare providers, who are in the frontline, who are really desperate and looking for solutions,” said authority chairperson Helen Rees.
“It is on this backdrop that the Ivermectin conversation needs to take place. We are very sensitive about this. We’ve had many conversations with expert committees, advisers and the board, and how we should proceed.” Rees said the authority will collect data as doctors use Ivermectin on their patients, simultaneously cautioning people who are desperate to protect themselves from the virus that they should be careful about self-medicating with it. There has also been concern about the sky-rocketing price of the drug on the black market, which has been openly advertised on social media despite this being illegal in South Africa. PTI FH RDK RDK