FDA To Review Safety Of Merck COVID Pill

by Sloan T. Wilson, The Chicago Times

November 28, 2021

WASHINGTON — Federal health officials said a Merck experimental COVID-19 pill is effective against the virus, but they will seek advice from other specialists on the dangers of birth abnormalities and other potential problems in pregnant women.

According to FDA scientists, their assessment uncovered various potential hazards, including poisoning and birth abnormalities.  Regulators also noticed that Merck obtained considerably less overall safety data on its medicine than was gathered for other COVID-19 therapies.

All COVID-19 medicines now approved by the FDA necessitate an injection or IV, limiting their use.  Merck’s medicine, if approved, would be the first that patients may take at home to relieve symptoms and expedite recovery.  It is already authorized for deployment in an emergency in the United Kingdom.

The FDA will consult with its independent experts to determine if the drug’s advantages exceed its hazards and whether its use should be restricted for pregnant women.