Merck announced it was seeking emergency authorization from FDA for the use of its drug on Oct. 11. | Merck & Co. via APThe Food and Drug Administration will ask independent advisers Tuesday whether to limit the use of a Covid-19 antiviral pill in pregnant people due to potential risks, according to agency documents posted Friday.
But studies in rats showed miscarriage and developmental abnormalities at the highest doses, leading the companies to recommend against using the drug during pregnancy — and for people who may get pregnant to use contraception while taking the pill and for four days following the last dose. Pregnant people were excluded from clinical trials.at-risk population from accessing a treatment that likely could be prescribed for at-home use.
The agency also will seek advice on an observed increase in the rate of mutations of the coronavirus spike protein among molnupiravir patients, including what risk or monitoring strategies should be considered.Merck announced it was seeking emergency authorization from FDA for the use of its drug on Oct. 11, days after reporting that the antiviral pill appeared to halve the risk of hospitalization or death from Covid in people at risk of developing severe disease.
“Antibiotics Are Not Automatic Anymore”
Take the red pill or the blue. 🤷♀️ Miscarriage is a serious side effect. Sounds toxic for anyone who takes it.
The FDA 'considering' COVID treatments.
Just saying...
Anyone else see a bunch of hot dogs?
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