Potential Covid-19 drug under spotlight
Prescriptions for Ivermectin have risen sharply this month, and the compound was produced locally by pharmacists until a notice was issued that the medicine is not approved for human use in Namibia.
28 January 2021 | Health
JANA-MARI SMITH
WINDHOEK
The local production of an anti-parasitic drug hailed as a potential game changing therapy for Covid-19 has been abruptly halted in Namibia in the wake of a notice that the medicine is not approved for human use in Namibia, and particularly not for Covid-19 treatment.
Originally designed as a veterinary drug, Ivermectin has been used to treat head lice, scabies and serious tropical diseases in humans since the early 1980s.
In Namibia, prescriptions for Ivermectin have risen sharply this month, and the compound was produced locally by pharmacists.
Ivermectin is under the global spotlight currently, following promising evidence of its ability to significantly improve survival rates, quicker viral clearance and recoveries.
Globally, medicine boards and international health organisations however have shied away from giving the green light for the use of Ivermectin as a treatment for Covid-19, citing a lack of robust data to support its safety and efficacy.
The Namibia Medicines Regulatory Council (NMRC) joined the prevailing cautionary approach this week.
“No clear conclusion can be drawn from the currently available data on the clinical efficacy and safety of ivermectin in the treatment of Covid-19,” the public notice, issued on Monday, stated.
The NMRC said the World Health Organisation and other global authorities, on whose guidance treatment protocols in Namibia are based, have not yet endorsed Ivermectin.
Johannes #Gaeseb, NMRC registrar, on Tuesday said the Council has not received any local applications for the import or use of the drug for humans.
The NMRC also warned the public from using the veterinary version of the medicine, following reports of a rush to buy the animal version of Ivermectin at Swavet, the wholesaler of veterinary drugs in Windhoek.
A pharmacist, who declined to be named for the article, confirmed that prescriptions for the drug have dramatically increased this month, but that the NMRC's notice has put a halt on production, and thus availability, of the drug for now.
She added that some doctors have used it not only as a preventative medication, but have said there is clear evidence that the treatment helps patients recover faster, and show less severe symptoms.
Close eye
Even de Klerk, NMRC council member, this week said the drug is not approved for human use in Namibia, although there have been sporadic cases of off-label use over the years.
He emphasized that the NMRC is keeping a close eye on international developments, and would keep the public, and health professionals, up to date as more sturdy evidence emerges.
He emphasized the NMRC has the scope to prohibit doctors from prescribing the medicine, or pharmacists from compounding it.
“The NMRC is the statutory body that regulates all medicines for veterinary and human consumption and devices in Namibia. It is our duty to monitor the studies to ensure the safety for medicines for both human and animal consumption.”
He added that the NMRC is aware of the potential benefits of Ivermectin, but are not satisfied there is sufficient data and evidence for its application against Covid-19.
De Klerk added that applications for compassionate use will stumble against the current lack of data on the safe use of the medicine for humans against Covid-19.
Mounting pressure
Preliminary findings from a meta-analysis, led by Dr Andrew Hill in the UK that was published this month, reviewing dozens of studies on Ivermectin's potential as a treatment for the illness found a “75% improvement in survival”, and other benefits.
Still, Dr Hill's paper including a warning that “despite the encouraging trend this existing data base demonstrates, it is not yet a sufficiently robust evidence base to justify the use or regulatory approval of Ivermectin.”
Prices for Ivermectin, usually a cheap drug, have soared in recent weeks around the world as many began to pin their hopes that this drug could significantly improve the disease's potential to kill.
Although there is general agreement that more in-depth studies are needed, many argue the deadly global health crisis warrants immediate approval of the drug against Covid-19.
Dr Nathi Mdladla, an associate professor and chief of ICU at Dr George Mukhari Academic Hospital in South Africa, recently posed the question: “What would our justification be if Ivermectin is eventually proven to be effective when the evidence has been around all along? Will the excuse for waiting for large multi-centre randomised controlled trials (RCTs) be justifiable to the thousands of families who have lost their loved ones?”
Writing for the Daily Maverick this month, he said the drug has been in use for four decades and dosed almost 3.5 million times, with negligible side effects.
He argues that considering the range of challenges faced, especially in under-resourced countries such as South Africa, even if “Ivermectin was 50% effective” it could save thousands of lives.
He urged authorities, especially in countries where vaccine roll-outs will take months, if not longer, to give “this cheap and effective drug a chance”.
In South Africa and elsewhere, doctors and lobbying groups have launched lawsuits to get the drug approved, while dozens of online petitions are underway asking governments to give the drug the green light.
WINDHOEK
The local production of an anti-parasitic drug hailed as a potential game changing therapy for Covid-19 has been abruptly halted in Namibia in the wake of a notice that the medicine is not approved for human use in Namibia, and particularly not for Covid-19 treatment.
Originally designed as a veterinary drug, Ivermectin has been used to treat head lice, scabies and serious tropical diseases in humans since the early 1980s.
In Namibia, prescriptions for Ivermectin have risen sharply this month, and the compound was produced locally by pharmacists.
Ivermectin is under the global spotlight currently, following promising evidence of its ability to significantly improve survival rates, quicker viral clearance and recoveries.
Globally, medicine boards and international health organisations however have shied away from giving the green light for the use of Ivermectin as a treatment for Covid-19, citing a lack of robust data to support its safety and efficacy.
The Namibia Medicines Regulatory Council (NMRC) joined the prevailing cautionary approach this week.
“No clear conclusion can be drawn from the currently available data on the clinical efficacy and safety of ivermectin in the treatment of Covid-19,” the public notice, issued on Monday, stated.
The NMRC said the World Health Organisation and other global authorities, on whose guidance treatment protocols in Namibia are based, have not yet endorsed Ivermectin.
Johannes #Gaeseb, NMRC registrar, on Tuesday said the Council has not received any local applications for the import or use of the drug for humans.
The NMRC also warned the public from using the veterinary version of the medicine, following reports of a rush to buy the animal version of Ivermectin at Swavet, the wholesaler of veterinary drugs in Windhoek.
A pharmacist, who declined to be named for the article, confirmed that prescriptions for the drug have dramatically increased this month, but that the NMRC's notice has put a halt on production, and thus availability, of the drug for now.
She added that some doctors have used it not only as a preventative medication, but have said there is clear evidence that the treatment helps patients recover faster, and show less severe symptoms.
Close eye
Even de Klerk, NMRC council member, this week said the drug is not approved for human use in Namibia, although there have been sporadic cases of off-label use over the years.
He emphasized that the NMRC is keeping a close eye on international developments, and would keep the public, and health professionals, up to date as more sturdy evidence emerges.
He emphasized the NMRC has the scope to prohibit doctors from prescribing the medicine, or pharmacists from compounding it.
“The NMRC is the statutory body that regulates all medicines for veterinary and human consumption and devices in Namibia. It is our duty to monitor the studies to ensure the safety for medicines for both human and animal consumption.”
He added that the NMRC is aware of the potential benefits of Ivermectin, but are not satisfied there is sufficient data and evidence for its application against Covid-19.
De Klerk added that applications for compassionate use will stumble against the current lack of data on the safe use of the medicine for humans against Covid-19.
Mounting pressure
Preliminary findings from a meta-analysis, led by Dr Andrew Hill in the UK that was published this month, reviewing dozens of studies on Ivermectin's potential as a treatment for the illness found a “75% improvement in survival”, and other benefits.
Still, Dr Hill's paper including a warning that “despite the encouraging trend this existing data base demonstrates, it is not yet a sufficiently robust evidence base to justify the use or regulatory approval of Ivermectin.”
Prices for Ivermectin, usually a cheap drug, have soared in recent weeks around the world as many began to pin their hopes that this drug could significantly improve the disease's potential to kill.
Although there is general agreement that more in-depth studies are needed, many argue the deadly global health crisis warrants immediate approval of the drug against Covid-19.
Dr Nathi Mdladla, an associate professor and chief of ICU at Dr George Mukhari Academic Hospital in South Africa, recently posed the question: “What would our justification be if Ivermectin is eventually proven to be effective when the evidence has been around all along? Will the excuse for waiting for large multi-centre randomised controlled trials (RCTs) be justifiable to the thousands of families who have lost their loved ones?”
Writing for the Daily Maverick this month, he said the drug has been in use for four decades and dosed almost 3.5 million times, with negligible side effects.
He argues that considering the range of challenges faced, especially in under-resourced countries such as South Africa, even if “Ivermectin was 50% effective” it could save thousands of lives.
He urged authorities, especially in countries where vaccine roll-outs will take months, if not longer, to give “this cheap and effective drug a chance”.
In South Africa and elsewhere, doctors and lobbying groups have launched lawsuits to get the drug approved, while dozens of online petitions are underway asking governments to give the drug the green light.
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