Paxlovid
An oral antiviral medication called Paxlovid is now available under Emergency Use Authorization by the FDA for treating mild-to-moderate COVID-19 in those ages 12 years and older, who weigh at least 88 pounds, and are at high risk for developing severe illness. During clinical trials, the medication reduced severe outcomes (hospitalization or death) by 88%.
Paxlovid is to be taken twice daily for 5 days, and treatment should begin within 5 days of symptoms first appearing. It is not recommended for those with certain medical conditions and could interact with other prescribed medications.
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Molnupiravir
Molnupiravir is an oral antiviral medication now available under Emergency Use Authorization by the FDA for treating COVID-19 in those 18 years and older with mild to moderate symptoms who are at high risk for developing severe illness and for whom alternative COVID-19 treatment options are not accessible or clinically appropriate. During clinical trials, it reduced the risk of hospitalization or death among patients with COVID-19 by 30%.
Molnupiravir is to be taken every 12 hours for 5 days with treatment beginning within the first 5 days after developing symptoms. Do not stop taking it before you complete the full 5 days of treatment, even if you feel better.
It's not recommended for use during pregnancy as it could cause fetal harm when given to pregnant individuals. Those of childbearing age should use a reliable method of birth control correctly and consistently during treatment and for four days after the final dose. People of reproductive potential who are sexually active with those of childbearing age should use a reliable method of birth control correctly and consistently during treatment and for at least three months after the final dose.
Molnupiravir is available by prescription only through some Walmart and CVS pharmacies.
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FAQs
What is an Emergency Use Authorization (EUA)?
Under section 564 of the Federal Food, Drug & Cosmetic Act, the FDA may, pursuant to a determination and declaration by the HHS Secretary, authorize an unapproved product or unapproved uses of an approved product for emergency use. In issuing an EUA, the FDA must determine, among other things, that the product may be effective in diagnosing, treating, or preventing a serious or life-threatening disease or condition caused by a chemical, biological, radiological, or nuclear agent; that the known and potential benefits outweigh the known and potential risks for the product; and that there are no adequate, approved, and available alternatives. Emergency use authorization is NOT the same as FDA approval or licensure.
How is high risk defined under the EUA?
High risk for progressing to severe COVID-19 and/or hospitalization is defined as patients who meet at least one of the following criteria
- Are ≥65 years of age
- Have a body mass index (BMI) ≥25
- Are pregnant
- Have a high-risk condition
Are there side effects of using Paxlovid?
Possible side effects include:
- Liver problems: Tell your healthcare provider right away if you have any of signs and symptoms of liver problems, including loss of appetite, yellowing of your skin and the whites of eyes (jaundice), dark-colored urine, pale-colored stools and itchy skin, stomach-area (abdominal) pain.
- Resistance to HIV medicines: If you have an untreated HIV infection, Paxlovid might lead to some HIV medicines not working as well in the future.
- Other possible side effects include an altered sense of taste, diarrhea, high blood pressure, and muscle aches.
Are there side effects of using molnupiravir?
Molnupiravir may cause serious side effects, including harm to your unborn baby. It's not known if it will harm your baby if you take it during pregnancy.
- It's not recommended for use in pregnancy.
- Molnupiravir has not been studied in human pregnancy, but when given to pregnant animals, molnupiravir caused harm to their unborn babies.
- You and your healthcare provider may decide you should take molnupiravir during pregnancy if there are no other COVID-19 treatment options authorized by the FDA that are accessible or clinically appropriate for you.
- If you and your healthcare provider decide you should take molnupiravir during pregnancy, you and your healthcare provider should discuss the known and potential benefits and the potential risks of taking molnupiravir during pregnancy.
Other possible side effects include:
- Diarrhea
- Nausea
- Dizziness
Is there a requirement for providers to report side effects as part of the EUA?
Yes. As part of the EUA, the FDA requires health care providers to report all medication errors and serious adverse events considered to be potentially related to treatment through FDA's MedWatch Adverse Event Reporting program. Providers can complete and submit the report online or download and complete the form, then submit it via fax at (800) FDA-0178.
Do patient outcomes need to be reported under the EUA?
No, reporting of patient outcomes is not required under the EUA. However, reporting of all medication errors and serious adverse events considered to be potentially related to treatment is required.