India has not included Merck’s COVID-19 pill in its national disease treatment protocol due to known safety concerns that have restricted its use elsewhere, stated the director of the state Indian Council for Medical Research, Balram Bhargava.
“We have to remember that this drug presents important safety problems“, he claimed.
“It can cause teratogenicity, mutagenicity, and can also cause cartilage damage and be detrimental to muscles. And what is more important, it will be necessary to use contraceptive methods for three months if this drug is administered, because the child that is born could have problems of teratogenic influence”.
Teratogenic drugs can harm the developing fetus, while mutagenic drugs can permanently change a person’s genetic material.
Merck and Indian drugmaker Dr Reddy’s Laboratories Ltd, which plan to release a generic version of the pill early next week, did not immediately respond to requests for comment.
Drugs in the same class as the pill Merck, called molnupiravir, have been linked to birth defects in animal studies. Merck It has said that similar studies of its drug – for longer and at higher doses than those used in humans – show that it does not cause birth defects or cancer.
Bhargava said Indian health experts had twice discussed Merck’s drug, which the country’s regulatory bodies approved late last month and will go on sale on the private market starting next week.
“The WHO has not included it, the UK has not included it for now. So far, the current recommendation is that it is not part of the treatment of the national working group“, He said.
The comments could hurt private sales of the drug when it goes on the market, as most doctors tend to follow the advice of federal health officials.
The US FDA’s Antimicrobial Drug Advisory Committee recommended the drug in November, by 13 votes in favor and 10 against, after discussing concerns that it could cause the virus to mutate, as well as possible birth defects. Both the scientists of the FDA What Merck have suggested that the drug is not recommended during pregnancy.
In November, the UK was the first country to approve the pill, but more trials are underway.
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