Insufficient data on use of Ivermectin

PETALING JAYA: Doctors have advised caution in regard to the use of Ivermectin to treat Covid-19.

Most agree that more research needs to be done to ensure its efficacy and rule out health risks.

Malaysian Pharmacists Society president Amrahi Buang pointed out that the drug has been registered in Malaysia by the National Pharmaceutical Regulatory Agency, but only for use on animals.

“No one has yet come forward to register the drug for human use,” he told theSun.

“Off label or outside indication under registration for human use is only for clinical trials.”

Amrahi, who is also former chief pharmacist officer at the University of Malaya Medical Centre, said the Health Ministry had only started clinical trials on Ivermectin in May and the results will not be known until September.

“I believe we should wait for that,” he stressed.

He said any doctor who prescribes the controlled drug and any pharmacist who dispenses it is in violation of the Poisons Act 1952.

Amrahi also said that politicians should not politicise the use of Ivermectin.

“It is very important for those who are commenting to do their homework based on research done by the experts. I say so because who will bear the consequences if it is approved without adequate research?”

Desspite advice given by the World Health Organisation that Ivermectin can be used only in clinical trials, several Opposition MPs are pushing for its use to treat Covid-19.

On Tuesday, Sungai Buloh MP Sivarasa Rasiah claimed that lives are being lost because patients are not given the drug, while Shah Alam MP Khalid Samad claimed there were no safety issues on the use of the drug.

Universiti Malaya (UM) epidemiology and public health expert Dr Sanjay Rampal said evidence-based principles should be used to evaluate the effectiveness and safety of vaccines and drugs for use in the pandemic.

“It is important to critically evaluate the validity of research reports before using them. Evidence from small heterogeneous studies suggests a possible protective effect of Ivermectin, but these studies are susceptible to various biases. There is a need for large higher-quality randomised controlled trials to answer this clinical question,” he said.

Expert in social and preventive medicine Prof Dr Victor Hoe, who is also with UM, said before rash decisions are made to approve any medication to treat or prevent a specific disease, there has to be evidence that the medication will improve the outcome.

“We need to learn from history. Take the story of the administration of Thalidomide, a drug developed in 1957 which was originally intended as a sedative or tranquilliser,” he said.

During the early phase of testing, the company that developed the drug found that it was deemed to be harmless to humans and with that information in hand, the drug was allowed to be sold over-the-counter without a doctor’s prescription.

“Later, the drug was re-purposed for treating other ailments such as colds, flu, nausea and even morning sickness in expectant mothers,” he said.

“While it was initially thought to be safe for pregnant women, concerns regarding birth defects arose in 1961 with more than 10,000 infants affected and about 40% of them died at birth, while those who survived had limb deformity as well as eye, urinary tract and heart problems.

“The scandal prompted governments and medical authorities around the world to ensure that any medication approved for human meets stringent criteria,” he added.

Hoe said current evidence on the use of Ivermectin is still inconclusive, and people should wait for more concrete evidence.

“We do not want to fall into the Thalidomide trap.”