Additional COVID-19 Rx Gets Green Light

FDA authorizes molnupiravir to treat COVID-19 in adults

(RxWiki News) The US Food and Drug Administration (FDA) has issued an emergency use authorization (EUA) for another COVID-19 treatment.

This new treatment is found under the name molnupiravir.

Available by prescription only, this drug must be given as soon as possible after a COVID-19 diagnosis and within five days of when symptoms start.

The FDA authorized molnupiravir to treat mild to moderate COVID-19 in adults who are at high risk for severe COVID-19, including hospitalization or death. This treatment is for those who can't receive or don't have access to other authorized COVID-19 treatment options.

Molnupiravir is available as a tablet to be taken by mouth every 12 hours for five days. It treats COVID-19 by preventing the virus from duplicating inside the body, according to the FDA.

Molnupiravir is not approved for those younger than 18 because it may affect bone and cartilage growth. The FDA also noted that this new treatment is not to be used to prevent COVID-19 before exposure or after being exposed.

Also, molnupiravir is not authorized for those who have already been admitted to the hospital. Furthermore, this new treatment is not a substitute for the COVID-19 vaccine.

“As new variants of the virus continue to emerge, it is crucial to expand the country’s arsenal of COVID-19 therapies using emergency use authorization, while continuing to generate additional data on their safety and effectiveness,” said Dr. Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research, in a press release.

It is important to note that an EUA is different from a full FDA approval. The safety and effectiveness of this treatment continues to be evaluated, the FDA noted.

Possible side effects of molnupiravir may include diarrhea, dizziness and nausea. Molnupiravir may cause harm to your unborn baby if taken during pregnancy. This warning is based on studies conducted in animals. This medication is not recommended to be taken while pregnant.

Speak with your health care provider if you have any questions.

Molnupiravir is a product of Merck.

Last Updated:
December 30, 2021