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Merck’s COVID pills appear to be effective, but can pose a risk of pregnancy: FDA

(HealthDay)-According to the US Food and Drug Administration, Merck’s experimental COVID-19 antivirals appear to be effective, but pose risks to pregnant women, including birth defects and toxicity to fetal development. There is a possibility.

Merck announced on Friday morning Updated result From the Molnupiravir study, which showed less profit than initially thought: Among the more than 1,400 adults in the company’s study drag The total risk of hospitalization and death was reduced by 30%, less than the initially reported 50%.

Approximately 7% of patients who received Merck’s medication within 5 days of COVID-19 symptoms were admitted to the hospital and one died. This was compared to 10% and 9 deaths in hospitalized patients taking placebo.

Analysis by FDA scientists has also identified potential risks in animal studies of molnupiravir. The authorities’ report was posted prior to a meeting by FDA outside experts on Tuesday. pill..

Based on the findings, the FDA Expert panel Should pills not be given during pregnancy or can they be used in certain situations where the benefits outweigh the risks? Considering safety concerns, FDA scientists said Merck agreed that the drug would not be used in children.

The agency does not have to follow the advice of the advisory board, but usually does.

According to the FDA, data from a small human clinical trial evaluating pills showed that “there are no significant safety concerns.” review.. About 2% of patients experienced diarrhea.

If approved, the pill will be the first US patient to take home to relieve symptoms and speed recovery.Emergency use is already permitted in the UK

Molnupiravir works by inserting a small mutation into the genetic code of the coronavirus to prevent the virus from multiplying.

FDA scientists say the drug causes small changes in the peplomers that the coronavirus uses to penetrate human cells, and in theory those changes could lead to dangerous new mutants. I paid attention to. AP report.


FDA: Merck COVID Pills Effective, Experts Review Safety


For more information:
For more information, please visit the US Food and Drug Administration COVID treatment..

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Quote: Merck’s COVID pill appears to be effective, but can pose a risk of pregnancy: FDA (2021, November 29) https://medicalxpress.com/news/2021-11- Obtained November 29, 2021 from merck-covid-pill-effective-pose.html

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Merck’s COVID pills appear to be effective, but can pose a risk of pregnancy: FDA

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