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SAHPRA scraps Ivermectin programme, advises against use

SA’s medicines regulator has advised doctors to stop prescribing the anti-parasitic drug, Ivermectin, for COVID-19 and has scrapped a controversial programme allowing doctors and hospitals to import the unregistered medicine from countries that had approved it.

In a statement on Monday, the SA Health Products Regulatory Authority (SAHPRA) said its decision to introduce the “compassionate access” programme for Ivermectin was taken at a time when COVID-19 vaccines were not widely available. This is no longer the case.

Business Day reports that Ivermectin has been widely touted as a COVID-19 treatment since the beginning of the coronavirus pandemic, despite limited evidence of its safety and efficacy.

Faced with its widespread and growing illicit use, SAHPRA had introduced a “compassionate access” programme for Ivermectin in January 2021. It hoped this would give it greater oversight of its use: apart from obtaining permission to import the drug, doctors and hospitals had to report back to the regulator on how their patients fared.

Since then, several of the studies on which SAHPRA based its decision to launch the programme have been retracted, and both the US Food and Drug Administration (FDA) and the World Health Organidation (WHO) have advised against the use of the medication except in clinical trials.

The Department of Health’s essential medicines list committee on COVID-19 took a similar stance last July, saying many of the published clinical trials were of such poor quality that they limited the strength of its conclusions on Ivermectin, and what little evidence there was did not suggest any clear benefit.

Several international studies have had to be withdrawn after data were found to be false or inaccurate.

MedicalBrief reports that in April, in the New England Journal of Medicine, a research team published its findings on the largest ever randomised Ivermectin trial “which failed to show benefit in COVID outpatients”.

SAHPRA’s decision to end the compassionate access programme was based on the lack of evidence for the efficacy and safety of Ivermectin for preventing or treating COVID-19, CEO Boitumelo Semete said.

However, SAHPRA has been unable to close off all avenues to Ivermectin. It is still possible for people to continue illicit use of Ivermectin products approved for animal use. Compounding pharmacies can still make the drug on their premises by using ingredients legally imported to make Soolantra, a topical cream used to treat the skin condition, rosacea.

Section 14 of the Medicines and Related Substances Act permits compounding pharmacies to mix drugs on site to meet the needs of an individual patient, but they may not manufacture in bulk.

SAHPRA had authorised 372 healthcare facilities to import bulk supplies of Ivermectin and received 628 applications from healthcare professionals for permission for specific patients to use the drug, but few complied with the regulator’s reporting requirements, Semete said.

“We (got) very poor reporting, which concerns us, because we don’t have complete data on the safety outcomes of the use of this product,” she said.

SAHPRA did not know how many compounding pharmacies were making Ivermectin for COVID-19, nor how many patients had obtained supplies in such a way, she said.

 

Business Day Pressreader article – Regulator advises against Ivermectin (Open access)

 

See more from MedicalBrief archives:

 

Largest yet Ivermectin trial fails to show benefit in COVID outpatients

 

Ivermectin: When desperate patients litigate for unproven treatments

 

Withdrawn: Mexican Ivermectin paper claiming reduced COVID hospitalisation

 

Ivermectin meta-analyses highlighted, again, the dangers of fake data

 

 

 

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