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Molnupiravir has serious safety concerns: ICMR chief – Times of India

NEW DELHI:Antiviral drug molnupiravir, which recently got approval from the drug regulator and is being launched by several local drug makers, has serious safety concerns, and thus has not been included in the national Covid-19 clinical protocol recommended by the health ministry, the Indian Council of Medical Research (ICMR) director general Balram Bhargava said.
Bhargava said the Covid-19 task force has debated whether to include the drug in the Covid-19 treatment protocol but decided against it because of concerns.
“The US has approved it only based on 1,433 patients with a 3% reduction in moderate disease when given in mild cases. However, we have to remember that this drug has major safety concerns. It can cause teratogenicity, mutagenicity , and it can also cause cartilage damage and can also be damaging to muscles,” Bhargava said.
“More importantly, if this drug is given to a man or a woman, contraception has to be used for three months, as the child conceived during that period may have problems with teratogenic influences. So, it is not included in the national clinical protocol, the WHO has not included it, nor has the UK,” he added.
Teratogenicity is the ability to cause defects in a developing foetus, whereas mutagenicity refers to permanent transmissible changes in the structure of genetic material of cells.
Bhargava further pointed out that there are concerns about children, pregnant and lactating women, those in reproductive age, soft tissue injury, history of infections and vaccinations when this drug is being prescribed.
Molnupiravir, originally developed by pharma company Merck, had initially claimed 50% reduction in hospitalisation or death in patients.