Sahpra has received fewer than 200 applications for its ivermectin compassionate-use programme

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  • Sahpra has received fewer than 200 applications for its Covid-19 ivermectin compassionate access programme 
  • It is yet to receive data from doctors who received approval to use the drug for treating Covid-19 patients
  • Researchers and the FDA say that there is not sufficient evidence to warrant the use of ivermectin as a treatment for Covid-19 

The South African Health Products Regulatory Authority (Sahpra) says it has received only 184 applications for compassionate use access to ivermectin in patients with Covid-19.

The body told Health24 that is has approved 13 named-patient applications, and applications for 104 healthcare facility stocks and seven suppliers.

Sahpra introduced the special programme for ivermectin in January. One of the conditions of the programme is that doctors provide the organisation with feedback on how the drug affects approved patients as part of the data being collected on the medicine.

However, the body told Health24 that it has not received any feedback from healthcare practitioners that received permission to treat Covid-19 with ivermectin.

“It is anticipated that feedback will be received when ivermectin products approved under the programme will be distributed to healthcare facilities from approved suppliers,” says Sahpra spokesperson Yuven Gounden.

The latest research on ivermectin

Although there have been some small studies indicating that ivermectin has some potential benefit with 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 (JAMA).

The researchers fsaid that: “Among adults with mild Covid-19, a 5-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.”

FDA warning

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

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

“The FDA has not reviewed data to support use of ivermectin in Covid-19 patients 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 to take the drug as 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, diarrhea, 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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