FDA Says Merck’s Covid-19 Pill is Effective But Still Needs Further Review

Federal health regulators say Merck’s experimental COVID–19 pill is effective against the virus. However, it still needs further review from outside experts on the risks of birth defects and other potential problems for pregnant women.

The Food and Drug Administration shared its analysis of the pill ahead of next week’s public meeting, where experts will weigh in on its safety and effectiveness. The agency, however, is not required to follow the group’s advice.

Scientists from the FDA said their review identified several potential risks with taking the pill, including possible toxicity and birth defects.

Regulators also pointed out that Merck collected far fewer safety data overall on its drug than was gathered for other therapies used for COVID-19.

All of the drugs currently authorized by the FDA to treat COVID-19 require an injection or IV, limiting their use.

If Merck’s pill is authorized, it would be the first drug patients could take at home to ease symptoms and speed recovery. The drug has already been approved for emergency use in the U.K.