Ivermectin: Sahpra agrees with FDA warning, monitors illegal sales

The South African Health Products Regulatory Authority (Sahpra) joined the United States Food and Drug Administration (FDA) to caution against the use of Ivermectin to treat Covid-19.

According to Sahpra, its position to align itself with the FDA is reflected in the statement issued in January this year, outlining its views on the drug and the Controlled Compassionate Use Programme.

“Sahpra echoes the FDA’s stance that Ivermectin does not have proven antiviral properties against SARS-COV-2, but it is currently used to treat parasitic conditions in animals.

“It is also used to treat certain conditions in humans such as very specific doses for some parasitic worms and there are topical formulations for head lice and skin conditions like rosacea.”

In August, the FDA said it had been receiving multiple reports of patients who had required medical support and had been hospitalised after self-medicating with Ivermectin intended for horses.

“The FDA has not approved Ivermectin for use in treating or preventing Covid-19 in humans. Ivermectin is not an anti-viral or a drug for treating viruses,” the US agency explained.

The local drug watchdog has since reiterated that taking such a drug without it undergoing the requisite testing and protocols could adversely affect people’s health and could lead to death.

Meanwhile, the Ivermectin Controlled Compassionate Use Programme, implemented by Sahpra on 28 January 2021, makes approved Ivermectin products accessible.

In South Africa, Sahpra said there is the registered Soolantra 10mg/g cream formulation, which contains ivermectin.

“Soolantra cream is indicated for the topical treatment of moderate to severe inflammatory lesions of papulopustular rosacea in adult patients and is not suitable for the prevention or treatment of Covid-19.

“As Sahpra’s focus is on the health and wellbeing of the South African public. Sahpra continuously engages the scientific and medical community to explore the options for controlled, monitored access to reliable quality Ivermectin-containing products for human use with simple but essential reporting requirements,” said Sahpra CEO, Dr Boitumelo Semete-Makokotlela.

In addition, Semete-Makokotlela said Sahpra is monitoring the illegal sale of so-called Ivermectin by unscrupulous individuals.

“The public should not buy any drug online or from unauthorised dealers,” she said.

Sahpra, like the FDA, cautioned against fake news and misinformation.         

It reminded citizens that medical professionals should oversee the medical treatment of any disease