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- Reports have emerged that SAHPRA had agreed to allow ivermectin for the treatment of Covid-19.
- But the regulator says this is not true and its position remains unchanged.
- However, a cream containing ivermectin was recently approved to treat a skin condition.
The South African Health Products Regulatory Authority (SAHPRA) said on Monday that reports on the approval of ivermectin for use in Covid-19 are “… extremely false and misleading.”
In a statement, SAHPRA CEO Dr. Boitumelo Semete said the SABC submitted an erroneous report that the body had agreed to allow the use of ivermectin in the treatment of Covid-19.
“This is wildly false, misleading to the public, irresponsible and could have dire consequences.”
Semete said the regulator’s position was unchanged.
“Ivermectin can be prescribed and dispensed to patients without waiting for section 21 authorization, but is still subject to receiving section 21 authorization, informed consent, and all the notification requirements normally required in section 21” .
The regulator had introduced its Controlled Compassionate Ivermectin Use Program in January.
Cream containing ivermectin approved, but not for Covid-19
In early March, Sahpra had registered an ivermectin product, a cream to treat a skin condition, unrelated to Covid-19.
In a statement, the regulator said: “On March 16, 2021, Sahpra registered Soolantra’s 10 mg / g cream formulation containing ivermectin. The holder of the registration certificate 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 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 related to 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 the data. emerging scientists in this regard and will respond accordingly.
“Sahpra has not received any application for the registration of a drug containing ivermectin for the management of Covid-19.”
As recently as March 19, Sahpra told Health24 that not many requests had been received for compassionate use access to ivermectin in Covid-19 patients.
At the time, the agency told Health24 that 184 applications had been received and that it had approved 13 applications from named patients and applications for 104 actions from health care centers and seven providers.
The latest 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 that found ivermectin did not speed recovery in Covid-19 patients. 19 mild.
The findings were important as it was a randomized controlled clinical trial. It was peer-reviewed and published in the Journal of the American Medical Association.
The researchers said: “Among adults with mild Covid-19, a five-day cycle of ivermectin, compared to placebo, did not significantly improve the time to resolution of symptoms.
“The findings do not support the use of ivermectin for the treatment of mild Covid-19, although larger trials may be necessary to understand the effects of ivermectin on other clinically relevant outcomes.”
Warnings from other global regulators
Just last week, the European Medicines Agency (EMA) issued a statement to warn against using ivermectin for the treatment of Covid-19, outside of proper clinical trials.
“The EMA has reviewed the most recent evidence on the use of ivermectin for the prevention and treatment of Covid-19 and concluded that the available data does not support its use for Covid-19 outside of well-designed clinical trials,” the statement said.
In the European Union (EU), ivermectin tablets are approved to treat some parasitic worm infestations, while ivermectin skin preparations are approved to treat skin conditions, such as rosacea, the EMA said.
He also said that ivermectin is licensed for veterinary use for a wide range of animal species for internal and external parasites.
The EMA also made clear that ivermectin products were not authorized for use in Covid-19 in the EU, and the body had also not received any requests for such use.
The EMA further explained: “Although ivermectin is generally well tolerated in doses authorized for other indications, side effects could increase with the much higher doses that would be necessary to obtain concentrations of ivermectin in the lungs that are effective against the virus.
“Toxicity, when ivermectin is used in higher than approved doses, cannot be excluded.”
Elsewhere, the US Food and Drug Administration (FDA) also warned against using ivermectin to treat Covid-19, in early March.
In a statement, the watchdog stated that 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 unauthorized use can be very dangerous. This also applies to ivermectin,” the statement read.
The body also says that caution is needed, even under approved circumstances, when taking the drug because it has dire side effects.
“Even ivermectin levels for approved uses can interact with other medications, such as blood thinners.
“You can also overdose on ivermectin, which can lead to nausea, vomiting, diarrhea, hypotension (low blood pressure), allergic reactions (itching and hives), dizziness, ataxia (balance problems), seizures, coma, and even death.” added. organization statuses.
