Regulator advises against ivermectin

SA’s medicines regulator has advised doctors to stop prescribing ivermectin for Covid-19 and scrapped a controversial programme that permitted doctors and hospitals to import the unregistered medicine from countries that had approved it. Ivermectin is an antiparasitic drug that has been widely touted as a Covid-19 treatment since the beginning of the coronavirus pandemic, despite limited evidence of its safety and efficacy.

SA’s medicines regulator has advised doctors to stop prescribing ivermectin for Covid-19 and scrapped a controversial programme that permitted doctors and hospitals to import the unregistered medicine from countries that had approved it.

Ivermectin is an antiparasitic drug that 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, the SA Health Products Regulatory Authority (Sahpra) introduced a “compassionate access” programme for ivermectin in January 2021. It hoped this would give it greater oversight of its use: in addition to obtaining permission to import the drug, doctors and hospitals were required 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Since then, several of the studies on which Sahpra based its decision to launch the programme have been retracted, and both the US Food and Drug Administration and the World Health Organization have advised against the use of ivermectin except in clinical trials. The department of health’s essential medicines list committee on Covid-19 took a similar stance last July.

The department said many of the published clinical trials were of such poor quality that it limited the strength of its conclusions on ivermectin and what little evidence there was did not suggest any clear benefit.

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 remains possible for people to continue illicit use of ivermectin products approved for animal use. Compounding pharmacies can still make the drug on their own premises, by using ingredients that are 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 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.

In a statement issued on Monday, the regulator emphasised that 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.

The national vaccination programme began in May 2021, starting with older people, and gradually opened up to younger age groups.

Demand for permits to import unregistered ivermectin appear to have fallen off since.

Sahpra said it had not received any applications from health facilities to import the drug since August 2021, and no individual named patient applications had been approved since December.