covid-19 pill

FDA: Merck COVID Pill Effective, Experts Will Review Safety


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The FDA scientists said their review identified several potential risks, including possible toxicity and birth defects. Given those risks the FDA will ask its advisers whether the drug should never be given during pregnancy or whether it could be made available in certain cases.



Additionally, the FDA flagged a concern that Merck's drug led to small changes in the coronavirus' signature spike protein, which it uses to penetrate human cells. Theoretically, FDA cautioned, those changes could lead to dangerous new variants.






Drugmaker Merck said Friday that its experimental COVID-19 pill reduced hospitalizations and deaths by half in people recently infected with the coronavirus.

Merck’s drug uses a novel approach to fight COVID-19: it inserts tiny mutations into the coronavirus’ genetic code to the point that it can’t reproduce itself.

But that genetic effect has raised concerns that in rare cases the drug could cause birth defects or tumors.

Pregnant women were excluded from Merck’s study. And both women and men in the study were instructed to use contraception or abstain from sex.

For its part, Merck says results from two company studies in rodents show “molnupiravir does not cause mutations or damage to DNA in these animal models.” The company said the rodents received higher doses for longer periods of time than humans who will take the drug.







Copyright AP - Associated Press
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