FDA panel backs first-of-a-kind COVID-19 pill from Merck
The Hindu
A Food and Drug Administration (FDA) panel voted 13-10 that the drug molnupiravir’s benefits outweigh its risks, including potential birth defects if used during pregnancy
A panel of U.S. health advisers narrowly backed the benefits of a closely watched COVID-19 pill from Merck, setting the stage for a likely authorisation of the first drug that Americans could take at home to treat the virus.
A Food and Drug Administration (FDA) panel voted 13-10 that the drug’s benefits outweigh its risks, including potential birth defects if used during pregnancy.
The group’s recommendation came after hours of debate about the drug’s modest benefits and potential safety issues. Experts backing the treatment stressed that it should not be used by anyone who is pregnant and called on FDA to recommend extra precautions before the drug is prescribed, including pregnancy tests for women of child-bearing age.