Federal health regulators said they will seek input from outside experts on risks of birth defects and other potential problems during pregnancy.
Federal health regulators said an from Merck is effective against, 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 agency’s scientists said their review identified several potential risks, including possible toxicity and birth defects. Given those risks the agency 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 agency 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. Given the safety concerns, the agency said Merck agreed the drug would not be used in children. Additionally, the agency flagged a concern that Merck’s drug led to small changes in the coronavirus‘ signature spike protein, which it uses to penetrate human cells.
