Merck COVID pills are effective, experts will review safety

Merck COVID pills are effective, experts will review safety

Federal health regulators say Merck’s experimental COVID-19 pill is effective against the virus, but they will seek input from outside experts about the risks of birth defects and other potential problems in pregnant women.

The FDA published its analysis of the pills ahead of a public meeting next week where academics and other experts will assess their safety and efficacy. The agency is not required to follow the advice of the group.

The FDA scientists said their review identified several potential risks, including potential toxicity and birth defects. Regulators also note that Merck has collected far less safety data overall on its drug than it has for other COVID-19 treatments.

All COVID-19 medications currently authorized by the Food and Drug Administration require an injection or IV syringe, which limits their use. If licensed, Merck’s drug would be the first drug patients could take at home to relieve symptoms and speed recovery. Already licensed for emergency use in the UK

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With cases rising again across much of the United States, regulators are expected to green-light Merck as an important new weapon to help ease the pressure on hospitals. But an FDA review is key to determining who will qualify and how broad their prescribing should be.

The Food and Drug Administration will ask its independent advisors whether the drug’s benefits outweigh its risks and whether its use should be restricted to pregnant women.

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