Home South African SA drugs regulator bans ‘miracle’ Covid-19 treatment as unsafe

SA drugs regulator bans ‘miracle’ Covid-19 treatment as unsafe


“At present, there is no confirmatory clinical evidence available for the use of ivermectin in the management of Covd-19 infections.”

File picture: Ayanda Ndamane/African News Agency/ANA

CAPE TOWN – The import into South Africa of ivermectin, a drug that has made international headlines recently as a so-called “miracle cure” for Covid-19, has been declared illegal by the South African Health Products Regulatory Authority (Sahpra).

Ivermectin, which has been used for decades to treat livestock and people infested with parasitic worms, was hailed as a revolutionary drug in the 1980s and works by paralysing and killing parasites.

In a statement, Sahpra chief executive Dr Boitumelo Semete-Makokotlela said: “Our stance is unambiguous. This drug is not approved by Sahpra and any attempt to import it into the country will be dealt with by Sahpra’s regulatory compliance unit in conjunction with law enforcement agencies such as the SAPS and the SIU.

“If any member of the public is aware of such transgressions, please contact Deon Poovan, senior manager of Sahpra’s Inspectorate and Regulatory Compliance on [email protected].

“At present, there is no confirmatory clinical evidence available for the use of ivermectin in the management of Covd-19 infections,” said Semete-Makokotlela.

“In terms of safety and efficacy, there is no evidence to support the use of ivermectin and we do not have any clinical trial evidence to justify its use.

“Sahpra is focused on quality, safety and efficacy and its ultimate goal is to protect the health and well-being of all those who live in South Africa. The use of such a drug could potentially lead to harmful effects or even death,” said Semete-Makokotlela.

Reached for comment, Western Cape head of health Dr Keith Cloete said: “We will be guided by the expert advice of the national Essential Medicine List (EML) committee and the ministerial advisory committee for Covid-19, who will pronounce on this matter.”

Provincial health department spokesperson Mark van der Heever said: “We only use medication and drugs which are approved by Sahpra.”

During a hearing before the US senate homeland security and governmental affairs committee last week, Dr Pierre Kory, a pulmonary and critical care specialist at Aurora St Luke’s Medical Center in Milwaukee, described ivermectin as a “wonder drug” with immensely powerful antiviral and anti-inflammatory agents.

Kory said: “Ivermectin is highly safe, widely available, and low cost. Its discovery was awarded the Nobel Prize in medicine, and is already included on the WHO’s World’s List of Essential Medicines. Ivermectin is effectively a miracle drug against Covid-19.”

The hearing went viral on social media with one clip receiving more than one million views on YouTube, and a number of people around the world, including in South Africa where the second wave of Covid-19 appears to be worse than the first time around, have since called for governments and regulators allow the drug for use against Covid-19.

The WHO and health authorities worldwide have urged people to be wary of so-called Covid-19 miracle cures.

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