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Ivermectin still not approved by SAMA

Ivermectin still not approved by SAMA

The South African Medical Association (SAMA) has pleaded with anxious members of the healthcare community to await convincing clinical evidence before jumping on to any Covid-19 vaccine.

Dr Angelique Coetzee, chairperson of SAMA, said despite the hype around Ivermectin for the prevention and treatment of Covid-19, convincing clinical evidence was yet to emerge from current trials.

Coetzee said while they understood the desperation for an easy and effective treatment, the use and safety of Ivermectin in humans had not been approved in South Africa.

If anything, she said it was important for the correct processes in approving medicines to be followed to the letter.

“Until the use of Ivermectin in humans for Covid-19 is declared safe by the Health Products Authority, we cannot advise doctors or other healthcare workers to use it, despite the growing body of evidence in support of its efficacy.

“Doctors are urged not to buy and sell unregistered products claiming to contain Ivermectin or promote these in any way. The composition of veterinary formulations is not done to the same stringent standards as medicines designed specifically for human use.”

Coetzee also added that under extraordinary circumstances, the health products authority could permit access to unregistered medicines, such as Ivermectin, in terms of the act.

She said however, the efficacy of the medicine was largely still in question and more studies were required.

“No First World country has approved this medicine for the treatment of Covid-19, and neither has the World Health Organization, so we have to follow due process.”

According to the South African Health Products Regulatory Authority, Ivermectin was widely used for the treatment and control of parasites in animals and to treat several tropical diseases in humans not commonly seen in South Africa, as well as scabies and head lice.

The body said Ivermectin was a synthetic derivative of the antiparasitic class of compounds known as avermectins.

In South Africa Ivermectin is registered for use under the Department of Agriculture for use in animals, meaning that vets and other trained personnel were allowed to prescribe it as an antiparasitic agent for a variety of animals.

The drug is currently not registered for human use, but the authority occasionally granted Section 21 permits for the use of topical Ivermectin as an unregistered product for the treatment of individual patients with severe cases of scabies or head lice.

Coetzee urged people to remember that despite its availability and listing on the World Health Organization drug list, nothing to date had been said of its efficacy or safety for humans battling Covid-19.


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