hospitalizations and deaths in patients at high risk of severe illness, according to trial data.
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How does the pill work?
Older people and those who have conditions like obesity, diabetes and heart disease would be eligible to get a prescription for Merck’s pills if they get sick from the coronavirus and cannot get treatments such as Pfizer’s newly authorized pills or monoclonal antibody treatments.
The pill is available to both vaccinated and unvaccinated people.
COVID patients would take four 200-milligram capsules at a time every 12 hours for five days, for a total of 40 capsules, the FDA said. The treatment will be available within a few weeks.
As with Paxlovid, patients should start their pill regimen as soon as possible after their COVID diagnosis, and within five days of symptom onset, according to the FDA.
Merck’s pill works by introducing errors into the virus’s genes to stop it from replicating. However, this has raised concerns about the risk that it could cause reproductive harm.
That is precisely why the FDA does not recommend the pill for women that are pregnant. The agency said that women who may become pregnant should use contraception while taking the pills and for at least four days after. The male partners of women who could become pregnant should use contraception while taking the pills and for at least three months after.
Molnupiravir is not authorized to be taken to prevent COVID infection in people who’ve been exposed to a sick person, the FDA noted. It also can’t be taken by patients who are so sick that they’ve landed in the hospital.
The FDA warned that the two antiviral pills should not be considered a substitute for vaccination.
Side effects observed in the clinical trial included diarrhea, nausea and dizziness.
To get Merck’s pills, the F.D.A. says, patients will need to test positive for the virus and get a prescription from a health care provider no more than five days after symptoms start.
For more information on COVID, visit our COVID-19 resource center.