One of India’s top health officials made major news last week with an announcement about safety concerns regarding an experimental treatment for COVID-19.
Director-General of the Indian Council of Medical Research Balram Bhargava used a news conference Wednesday to say the pharmaceutical giant Merck’s experimental COVID-19 pill, known as molnupiravir, will not be added to the country’s national treatment protocol, according to The Economic Times.
He cited the “major safety concerns” surrounding this pill for this decision, according to Reuters, including the potential to cause birth defects — technically known as teratogenicity — potential DNA damage — known as multagenicity — and other problems.
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“It can cause teratogenicity, mutagenicity and it also can cause cartilage damage and be damaging to muscles,” Bhargava said, according to Reuters.
“More importantly, contraception will have to be used for three months if this drug is given because the child born could be problematic with teratogenic influences.”
“The [World Health Organization] WHO has not included it, the UK has not included it as of now,” he noted.
“As of now, the current recommendation stands that it is not part of the national task force treatment.”
Bhargava added that the Drugs Controller General of India approved molnupiravir for emergency use in December.
Reuters reported that drugs in the same class as molnupiravir have been associated with birth defects in animal studies.
Yet, the news agency pointed out Merck’s claims that similar studies of this drug, “for longer [periods of time] and at higher doses than used in humans, show that it does not cause birth defects or cancer.”
Meanhwhile, the FDA has granted emergency use authorization to the pill in the U.S, according to Reuters.
“The pill is not recommended for use during pregnancy,” Reuters noted.
The article also reported that the FDA “advised that men of reproductive potential use a reliable method of birth control during treatment with molnupiravir, and for at least three months after the final dose.”
The FDA’s decision came a day after giving “broader go-ahead” to a Pfizer pill to fight the coronavirus, Reuters reported.
“Pfizer’s antiviral regimen, Paxlovid, was nearly 90% effective in preventing hospitalizations and deaths in patients at high risk of severe illness, according to data from the company’s clinical trial,” Reuters reported. “Recent lab data suggests the drug retains its effectiveness against Omicron, Pfizer said.”
The pill was approved for those 12 and older at risk of serious illness.