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Estelle Sinkiins
2 minute read
27 Jan 2021

Ivermectin to be allowed for Covid-19 patients under new regulations

Estelle Sinkiins

South Africa’s drugs regulator has approved the ‘compassionate’ use of Ivermectin to treat patients with Covid-19.

South Africa’s drugs regulator has approved the ‘compassionate’ use of Ivermectin to treat patients with Covid-19.

Speaking at an event hosted by the National Press Club, Boitumelo Semete-Makokotlela, the chief executive officer of the South African Health Products Regulatory Authority (Sahpra), said the decision had been taken to ensure people could take the drug safely.

She added that Sahpra had obtained a lot of anecdotal evidence of medical practitioners prescribing Ivermectin off-label and of people trying to get the tablets on the black market.

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By allowing controlled compassionate use of Ivermectin they hope to stop this.

Professor Helen Rees, founder and executive director of the Wits Reproductive Health and HIV Institute, added: “Illegal importage becomes a safety concern because the drug you are being sold may not even be Ivermectin and you may take the wrong dose.

“As the regulator, Sahpra has to consider the safety aspect.”

Ivermectin is currently only registered for veterinary products in South Africa. It is used to treat parasitic conditions in livestock.

There has also been some limited use, under section 21 rules, to allow doctors to treat people with headlice and scabies.

Semete-Makokotlela said Sahpra will be issuing detailed guidelines on who will be able to dispense Ivermectin and how it will be done in the coming days.

Sahpra CEO, Boitumelo Semete-Makokotlela.

She added, however, that as part of the ‘compassionate use’, medical practitioners would have to provide them with ongoing feedback on how patients reacted to the drug, telling them if it has been effective and what side effects occur.

Sahpra — like the World Health Organisation, the Federal Drugs Administration in the United States, Britain’s Medicines and Healthcare Products Regulatory Agency, and health regulators in Europe — has been waiting for better clinical data on Ivermectin to become available.

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The regulator said that existing trials into the effectiveness of the drug have been small and the data presented insufficient to allow them to approve large-scale use.

Rees said larger clinical trials, together with the information from medical practitioners, would help Sahpra to make a firm decision of both the safety and efficacy of Ivermectin in treating Covid-19.

“Everyone wants more data. That will be the game changer,” she added.