Federal health officials say an experimental COVID-19 pill from Merck is effective against the virus, but they will seek outside experts on the risks of birth defects and other potential problems in pregnant women.
The Food and Drug Administration released its analysis of the pill ahead of a public meeting next week where academic and other experts will weigh its safety and effectiveness. The agency is not obliged to follow the advice of the group.
FDA scientists said their review identified several potential risks, including potential toxicity and birth defects. Regulators also noted that, overall, Merck has collected far less safety data on its drug than it has on other COVID-19 therapies.
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All COVID-19 drugs currently approved by the FDA require an injection or IV, which limits their use. If approved, Merck’s drug would be the first drug patients could take at home to relieve symptoms and speed recovery. In the UK it is already approved for emergencies
With cases picking up again in most parts of the United States, regulators are expected to clear Merck’s drug as an important new weapon to ease the burden on hospitals. But the FDA review is key to determining who is eligible and how far it could be prescribed.
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The FDA will ask its independent advisors whether the drug’s benefits outweigh its risks and whether its use should be restricted in pregnant women.