FDA: Merck COVID pill effective, experts will review safety

U.S. health officials say Merck's experimental COVID-19 pill is effective but they raised questions about its safety during pregnancy

Federal health regulators say an experimental COVID-19 pill from Merck is effective against the virus, but they will seek input from outside experts on risks of birth defects and other potential problems during pregnancy.

The Food and Drug Administration posted its analysis of the pill ahead of a public meeting next week where academic and other experts will weigh in on its safety and effectiveness. The agency isn’t required to follow the group’s advice.

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.

Under that scenario, the FDA said the drug would carry warnings about risks during pregnancy, but doctors would still have the option to prescribe it in certain cases where its benefits could outweigh its risks for patients.