Pfizer’s antiviral oral drug developed to treat COVID-19 can cause severe or life-threatening effects when used with common medications including some anti-coagulants, some anti-depressants, and some cholesterol-lowering statins, according to the Food and Drug Administration (FDA) (pdf).
FDA does not recommend Paxlovid for those with severe kidney or liver disease.
The FDA on Dec. 22 granted emergency use authorization (EUA) to Pfizer’s COVID-19 treatment pill as treatment for mild-to-moderate cases of COVID-19 in patients from 12 years of age.
Paxlovid was the first oral medication of its kind authorized by the FDA to treat COVID-19, with the aim of reducing the need for hospitalization before patients become too ill from the infection.
“This authorization provides a new tool to combat COVID-19 at a crucial time in the pandemic as new variants emerge and promises to make antiviral treatment more accessible to patients who are at high risk for progression to severe COVID-19,” stated Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research.
Paxlovid consists of a cocktail of two drugs, the first being nirmatrelvir, which stops the SARS-CoV-2 virus from replicating, while the second component acts to prolong the duration of nirmatrelvir.
The EUA came a month after the federal government announced it would purchase 10 million courses of the drug.
Earlier in November, the Biden administration had already purchased some 10 million courses of the drug in a more than $5 billion agreement.
“Pending EUA, U.S. will receive doses starting in 2021 and throughout 2022 as part of contract agreement with Pfizer,” Health and Human Services (HHS) stated in a statement.
HHS Secretary Xavier Becerra on Nov. 18 emphasized the importance of “getting vaccinated” even when Paxlovid becomes available.
“Getting vaccinated remains the most important action anyone can take to help protect themselves and others and end this pandemic, but for people who do get sick in the future and are at risk of severe outcomes, having pills they can take to keep them out of the hospital could be a lifesaver,” Becerra stated. “This agreement would help ensure millions of doses of this drug would be available to the American people if it is authorized.”
Earlier in December, Pfizer announced that the pill is able to reduce the risk of hospitalization or death from the CCP (Chinese Communist Party) virus by 89 percent when taken shortly after initial symptoms.
Pfizer CEO Albert Bourla on Dec. 8 told CNBC that shipments of the pill have arrived in the United States, “so product will be available this month if it’s approved.”