Pfizer’s Covid-19 Pill Authorized in U.S.
But it doesn’t come without side effects because you have to take another drug ritonavir with it.
Some researchers have raised safety concerns, because Paxlovid is taken with another drug. The second drug, called ritonavir, helps Paxlovid fight the virus longer, but can cause side effects when taken with certain widely used heart and cholesterol medicines.
Under the authorization, the FDA said Paxlovid shouldn’t be used with certain drugs for conditions including cancer, irregular heart rhythms and depression.
The FDA also recommended against giving Paxlovid to patients with severe kidney disease or liver impairment and said patients with moderate kidney issues should take a reduced dose. In patients with moderate renal impairment, a reduced Paxlovid dose is needed, it said.
European health regulators, who are reviewing Pfizer’s application for Paxlovid clearance, recently issued preliminary guidelines recommending that people don’t use it if they are pregnant or are trying to get pregnant, or if they are taking certain medicines or have severely reduced kidney or liver function.
Pfizer has said it expects doctors and pharmacists will find most of the drug interactions to be manageable.
Under the authorization, patients age 12 and older should begin a course of treatment within several days of symptoms emerging to prevent their cases from turning serious and requiring hospitalization.
People with a prescription would take two Paxlovid pills and one ritonavir pill twice a day for five days.
Pfizer has licensed Paxlovid’s formula so that generic drugmakers can make it for low- and middle-income countries.
Pfizer is also studying the drug in a separate study in adults at lower risk of developing severe disease, including vaccinated individuals.