Confusion over ivermectin, but regulator maintains it's not approved for Covid-19 treatment

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  • Reports have emerged that SAHPRA had agreed to allow ivermectin for Covid-19 treatment.
  • But the regulator says this is not true, and its position remains unchanged.
  • A cream containing ivermectin was recently approved though - to treat a skin condition.

The South African Health Products Regulatory Authority (SAHPRA) on Monday said reports of ivermectin being approved for use in Covid-19 are, "... grossly untrue, and misleading".

In a statement, SAHPRA CEO Dr Boitumelo Semete said an erroneous report was placed by the SABC, that the body had agreed to allow for the use of ivermectin in treating Covid-19.

"This is grossly untrue, misleading to the public, and irresponsible, and could have dire consequences."

Semete said the regulator's position remained unchanged.

"Ivermectin may be prescribed and dispensed to patients without awaiting section 21 authorisation, but is still subject to receiving section 21 authorisation, informed consent, and all reporting requirements normally required under section 21."

The regulator had introduced its Ivermectin Controlled Compassionate Use Programme in January.

Cream containing ivermectin approved - but not for Covid-19

Earlier in March, Sahpra had registered an ivermectin product - a cream, to treat a skin condition - not related to Covid-19.

In a statement, the regulator said: "On 16 March 2021, Sahpra registered Soolantra 10mg/g cream formulation, which contains ivermectin. The holder of the certificate of registration is Galderma South Africa.

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

SAHPRA added that the registration of the cream, "... is not in response to any of the current pending court cases regarding access to ivermectin for the prevention or treatment of Covid-19".

The statement further added that the regulator's position on ivermectin had not changed: "To date, there is insufficient scientific evidence on the efficacy of ivermectin for the prevention or treatment of Covid-19... Sahpra will continue to monitor emerging scientific data in this regard and will respond accordingly.

"Sahpra has received no application for the registration of an ivermectin-containing medicine for the management of Covid-19."

As recently as 19 March, Sahpra told Health24 that not many applications had been received for compassionate use access to ivermectin in patients with Covid-19.

At the time, the body told Health24 that 184 applications had been received, and that it had approved 13 named-patient applications, and applications for 104 healthcare facility stocks and seven suppliers.

The most recent scientific evidence on ivermectin

Although there have been some small studies indicating that ivermectin has some potential benefit in treating Covid-19, earlier this month Health24 reported on a study where it was found that ivermectin did not speed recovery in patients with mild Covid-19.

The findings were of significance as this was a randomised and controlled clinical trial. It was peer-reviewed and published in the Journal of American Medical Association.

The researchers said: "Among adults with mild Covid-19, a five-day course of ivermectin, compared with placebo, did not significantly improve the time to resolution of symptoms.

"The findings do not support the use of ivermectin for treatment of mild Covid-19, although larger trials may be needed to understand the effects of ivermectin on other clinically relevant outcomes."

Warnings from other global regulators

Just last week, the European Medicines Agency (EMA) released a statement to caution against the use of ivermectin for Covid-19 treatment, outside of proper clinical trials.

"EMA has reviewed the latest evidence on the use of ivermectin for the prevention and treatment of Covid-19 and concluded that the available data do not support its use for Covid-19 outside well-designed clinical trials," the statement said.

In the European Union (EU), ivermectin tablets are approved for treating some parasitic worm infestations, while ivermectin skin preparations are approved for treating skin conditions, such as rosacea, the EMA said.

It also said ivermectin is authorised for veterinary use for a wide range of animal species for internal and external parasites.

The EMA also made it clear that ivermectin products were not authorised for use in Covid-19 in the EU, and the body had also not received any application for such use.

The EMA further explained: "Although ivermectin is generally well-tolerated at doses authorised for other indications, side-effects could increase with the much higher doses that would be needed to obtain concentrations of ivermectin in the lungs that are effective against the virus.

"Toxicity, when ivermectin is used at higher than approved doses, therefore cannot be excluded."

Elsewhere, the Food and Drug Administration (FDA) in the United States also warned against the use of ivermectin for treating Covid-19, early in March.

In a statement, the watchdog stated there was not enough research to support the use of the drug to treat Covid-19.

"The FDA has not reviewed data to support the use of ivermectin to treat or prevent Covid-19; however, some initial research is underway.

"Taking a drug for an unapproved use can be very dangerous. This is true of ivermectin, too," the statement reads.

The body also says that caution is needed, even under approved circumstances, in taking the drug because it has dire side-effects. 

"Even the levels of ivermectin for approved uses can interact with other medications, like blood-thinners.

"You can also overdose on ivermectin, which can cause nausea, vomiting, diarrhoea, hypotension (low blood pressure), allergic reactions (itching and hives), dizziness, ataxia (problems with balance), seizures, coma and even death," the organisation states. 

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