The federal health regulators say an experimental COVID 19 pill from Merck is effective against the disease, 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 academics and other experts will weigh in on its safety and effectiveness. The agency isn't required to follow the advice of the group.
The FDA scientists said they identified several potential risks, including possible toxicity and birth defects. Regulators noted that Merck collected less safety data on its drug than was gathered for other COVID- 19 therapies.
All COVID 19 drugs that are currently authorized by the FDA require an injection or IV, which limits their use. If approved, 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.
With cases rising again across most of the U.S. regulators are expected to approve Merck's drug as an important new weapon to help relieve the strain on hospitals. The FDA review is a key factor in determining who will be eligible and how widely it might be prescribed.
The FDA will ask its independent advisers whether the benefits of the drug outweigh its risks and if it should be restricted for pregnant women.