The FDA granted emergency use authorization for Merck’s COVID-19 oral antiviral, molnupiravir, on December 23, 2021.
A review of the EUA fact sheet for molnupiravir revealed alarming statements for prospective users, especially for sexually active men.
In section 8.3, titled “Females and Males of Reproductive Potential,” the FDA advises men to use a reliable method of contraception during treatment and for at least three months after the last dose.
The FDA admits the risk beyond three months is currently unknown. Studies investigating the potential for molnupiravir to affect offspring of treated males are ongoing.
Merck’s COVID-19 pill encourages sexually actively men “to use a reliable method of contraception correctly and consistently during treatment and for at least 3 months after the last dose of molnupiravir. The risk beyond 3 months after the last dose of molnupiravir is unknown” pic.twitter.com/VVdh9cWrHx
— Chief Nerd (@TheChiefNerd) January 29, 2022
https://twitter.com/SeivwrightTrudy/status/1487996937236267013
As stated by the FDA:
Contraception
Females
Advise individuals of childbearing potential to use a reliable method of contraception correctly and consistently, as applicable for the duration of treatment and for 4 days after the last dose of molnupiravir [see Warnings and Precautions (5.1)].Males
While the risk is regarded as low, nonclinical studies to fully assess the potential for molnupiravir to affect offspring of treated males have not been completed. Advise sexually active individuals with partners of childbearing potential to use a reliable method of contraception correctly and consistently during treatment and for at least 3 months after the last dose of molnupiravir. The risk beyond three months after the last dose of molnupiravir is unknown. Studies to understand the risk beyond three months are ongoing.
While ivermectin has a better safety profile than Tylenol, molnupiravir showed horrendous side effects in animal trials.
Molnupiravir caused such significant harm to fetuses in animal models that Merck has suggested ensuring contraceptive use during *and* after treatment, actively generates mutations that could theoretically lead to new variants & has a mechanism of action that may cause cancer
— Mason (𝕏/acc) (@webdevMason) December 9, 2021
Just got an email from someone who was told by his doctor that he would not give him the monoclonals if he took ivermectin, but the same doc had no problem prescribing Merck's new drug, which caused birth defects in the rats. It's Moloch.
— Daniel Horowitz (@RMConservative) January 31, 2022
Cont. from the FDA’s molnupiravir fact sheet:
Animal Data
In an embryofetal development (EFD) study in rats, molnupiravir was administered orally to pregnant rats at 0, 100, 250, or 500 mg/kg/day from gestation days (GDs) 6 to 17. Molnupiravir was also administered orally to pregnant rats at up to 1,000 mg/kg/day from GDs 6 to 17 in a preliminary EFD study. Developmental toxicities included post-implantation losses, malformations of the eye, kidney, and axial skeleton, and rib variations at 1,000 mg/kg/day (8 times the human NHC exposure at the RHD) and decreased fetal body weights and delayed ossification at ≥500
mg/kg/day (3 times the human NHC exposure at the RHD). There were no developmental toxicities at ≤250 mg/kg/day (less than the human NHC exposure at the RHD). Maternal toxicities included decreased food consumption and body weight losses, resulting in the early sacrifice of two of sixteen animals at 1,000 mg/kg/day, and decreased body weight gain at 500 mg/kg/day.
Although 13 Indian companies earned permission to manufacture molnupiravir, the antiviral drug isn’t included in the national list of treatments.
Dr. Balram Bhargava, the Director General of the Indian Council Of Medical Research (ICMR), cited major safety concerns for Merck’s COVID-19 pill.
“India has not added Merck's pill to the list of treatments for Covid.
"Molnupiravir has major safety concerns including mutagenicity, muscle and bone damage. If this drug is given contraception has to be done for three months as child may have problems.” https://t.co/E92s5Zsu2v— ugot2bgood (@MarthaAlberts17) January 5, 2022
🚨 MOLNUPIRAVIR Trial in Wales whilst India issues a SECOND warning in a week that Molnupiravir harms far outweigh claimed benefits, pill unanimously rejected for inclusion in treatment Guidelines.https://t.co/SCZ5A8ECL4https://t.co/uI9pHJQptR pic.twitter.com/avuIlnStuL
— Sandra Weeden (@SandraWeeden) January 13, 2022
NDTV explained:
“Molnupiravir has major safety concerns including mutagenicity, muscle and bone damage. If this drug is given contraception has to be done for three months as child may have problems. So it is not included in national task got treatments,” Dr Bhargava said.
The announcement came just days after the Drugs Controller General of India gave emergency use approval to the drug along with two vaccines.
With a view to turn India into a manufacturing hub, Merck has entered into licensing agreements with eight domestic drugmakers to make and supply generic versions of Molnupiravir to over 100 low and middle-income countries.
The Tribune cited an additional warning from the ICMR:
In its second warning against the use of Molnupiravir, the world’s first anti-Covid oral pill developed by Merck, the Indian Council of Medical Research on Wednesday said the harms of the anti-viral pill far outweigh its benefits.
The ICMR noted irrational use of the pill which the Drug Controller General of India approved on December 28 last year and said while the pill has been approved in the UK and Denmark, it has not made to the Covid treatment guidelines there also.
In India, the national task force experts have for the third time unanimously rejected the inclusion of the drug in the Indian Covid-19 treatment guidelines.
“We had extensive discussions among national experts and reviewed whatever data was available from three trials – one on 1433 patients in the US; one which was prematurely terminated for business reasons and another that is ongoing. The conclusion is that Molnupiravir has certain risks that warrant caution in its use. Experts present at the meeting opined that there is a rampant and irrational use of the pill. They said efforts should be made to restrict its use as known and unknown harms far outweigh its claimed benefit,” ICMR chief Balram Bhargava said today.
Join the conversation!
Please share your thoughts about this article below. We value your opinions, and would love to see you add to the discussion!