- Sahpra has seen a decline in applications for its ivermectin Controlled Compassionate Use Access programme
- The body says that they have received little feedback from approved applications
- Sahpra launched the programme to ensure that approved products reach the patients and that illicit formulations and veterinary products are not used
The South African Health Products Regulatory Authority (Sahpra) says that they have seen a decline in applications for their ivermectin Controlled Compassionate Use Access programme for Covid-19.
“The application numbers were higher in February and March but have significantly declined since then,” Saphra spokesperson Yuven Gounden told Health24.
The programme was launched at the end of January this year as various doctors lobbied for the drug to treat Covid-19. So far, Sahpra has approved 160 out of 214 applications since the start of the programme.
As part of the conditions set by the body, doctors who have gained approval to use ivermectin are supposed to send Sahpra feedback on their patients’ outcomes as a result of using the drug as part of Covid-19 treatment.
But Gounden says that report-back from doctors on treatment outcomes has been poor.
Following the FDA
Sahpra has come under fire for not approving the use of ivermectin for human use despite it being approved by the United States Food and Drug Administration (FDA). However, the FDA has not approved the drug for Covid-19 treatment.
“It reminds the potential user that the FDA hasn’t registered it for the treatment of Covid-19 infections and that taking large doses of this drug is dangerous and can cause serious harm.
“Sahpra has taken the opportunity to implement the compassionate use programme to ensure that approved products reach the patients and that illicit formulations and veterinary products are not used in desperation.
"The programme also allows Sahpra to collect treatment outcomes while clinical trials are ongoing to evaluate the use of ivermectin in the treatment and prevention of Covid-19 infections,” says Gounden.
Lack of evidence of effectiveness
Local experts say that the use of ivermectin as a treatment and prevention medicine lacks evidence. In a Health24 report, experts stress that there is a need for more clinical trials to observe the impact of ivermectin on the treatment or prevention of Covid-19.
The experts warn that the unsupervised use of the drug, primarily where a healthcare professional does not administer doses, can lead to overdosing, which can be lethal.
*For more Covid-19 research, science and news, click here.