Covid-19 drug Molnupiravir flagged for 'major safety concerns'

Newly approved anti Covid-19 drug Molnupiravir has "major safety concerns," India's top health research body said on Wednesday. "Molnupiravir has major safety concerns including teratogenicity, mutagenicity, muscle and bone damage. If this drug is given, contraception must be done for three months as the child may have problems," Balram Bhargava, director general, Indian Council of Medical Research (ICMR), said on Wednesday.

Bhargava said that the approval in the US was based on 1,433 patients with a 3% reduction in moderate disease when given in mild cases. However, "we must remember that this drug has major safety concerns," he said, adding that the drug causes teratogenicity, mutagenicity, cartilage damage and muscle damage.

More importantly, he said contraception will have to be done for three months if this drug is given for male and female because "the child born could be problematic with teratogenic influences," he said. He said they have not included it in the national treatment; even the WHO, UK, have not included it as of now.


Bhargava said experts are concerned about issues regarding pregnancy, lactation, children's soft tissue injury, reproductive age group, history of infection and vaccination. "Whatever benefit is there was on these 1,433 patients and they were unvaccinated individuals. There was only 3% reduction from mild to moderate disease. As of now, where the current recommendations stand is that it is not part of the treatment," he further said.

The experts have reviewed it and are going to discuss it again, Bhargava said.