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 in pregnant women.
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. Regulators also noted Merck collected far less safety data overall on its drug than was gathered for other COVID-19 therapies.
All COVID-19 drugs currently authorized by the FDA require an injection or IV, which limits their use. If authorized, Merck’s drug would be the first that patients could take at home to ease symptoms and speed recovery. It is already authorized for emergency use in the U.K.
Medicine pill is seen with Merck logo displayed on a screen in the background in this illustration photo taken in Poland on Nov. 5, 2021. (Photo by Jakub Porzycki/NurPhoto via Getty Images)
With cases rising again across most of the U.S., regulators are expected to greenlight Merck’s drug as an important new weapon to help ease the strain on hospitals. But the FDA review is key to determining who will be eligible and how widely it might be prescribed.
FDA will ask its independent advisers whether the drug's benefits outweigh its risks and if its use should be restricted for pregnant women.
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