FDA seeks advice on whether to limit Covid-19 pill in pregnant people

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Coronavirus

Regulators are considering whether to authorize the pill’s emergency use in adults who have been experiencing symptoms for less than five days and, if so, how to define who’s considered high risk.

Merck announced it was seeking emergency authorization from FDA for the use of its drug on Oct. 11. | Merck & Co. via AP

By LAUREN GARDNER

11/26/2021 11:07 AM EST

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The Food and Drug Administration will ask independent advisers Tuesday whether to limit the use of a Covid-19 antiviral pill in pregnant people due to potential risks, according to agency documents posted Friday.

Merck and partner Ridgeback Biotherapeutics manufacture the drug, molnupiravir, which they say cuts in half the risk of hospitalization or death from Covid for patients with mild to moderate disease and has boosted hopes of finding a simple at-home treatment for the virus. Regulators are considering whether to authorize the pill’s emergency use in adults who have been experiencing symptoms for less than five days and, if so, how to define who’s considered high risk.

But studies in rats showed miscarriage and developmental abnormalities at the highest doses, leading the companies to recommend against using the drug during pregnancy — and for people who may get pregnant to use contraception while taking the pill and for four days following the last dose. Pregnant people were excluded from clinical trials.

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