The CDC director, Rochelle Walensky, just issued an alert on Pfizer’s COVID-19 pill, suggesting, “you might get symptoms again” after using Paxlovid, so we decided to take a look at the package insert to better understand what the known and unknown risks were.
Pfizer received Emergency Use Authorization for Paxlovid on December 22, 2021, for adults and children who are at least 12 years old and weigh at least 88 pounds, with a positive test for the virus that causes COVID-19, and who are at high risk for progression to severe COVID-19, including hospitalization or death.
PAXLOVID is comprised of two drugs: nirmatrelvir tablets co-packaged with ritonavir tablets. The package insert states that, “there is limited information about the safety and effectiveness of using PAXLOVID to treat people with mild-to-moderate COVID-19.”
A list of nearly 100 medications that cause potentially life-threatening side effects when used with Paxlovid has been provided, including anticancer drugs, anticonvulsants, antipsychotics, antidepressants, antifungals, CCBs, immunosuppressants, and more. These are not the only medications that may cause serious side effects, just the ones Pfizer has already confirmed can cause life-threatening side effects.
Additionally, Paxlovid can result in allergic reactions (e.g., hives, trouble swallowing, difficulty breathing, swelling of the mouth, throat tightness, hoarseness, skin rash), liver problems (e.g., hepatitis, jaundice), resistance to HIV medications, altered sense of taste, high blood pressure, diarrhea, muscle aches, and more since it “is still being studied" so it’s possible that all of the risks aren’t known yet. Paxlovid may also interfere with hormonal contraceptives.
There are no available human data on the use of nirmatrelvir during pregnancy to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. There is no experience treating breastfeeding mothers either, but a rat study showed a transient decrease in body weight of offspring of rats administered nirmatrelvir.
Detectable levels of ritonavir have been observed in cord blood samples and neonate hair, confirming it is passed through the placenta.
When given 11x the authorized human dose, rabbits developed resorptions (i.e., the absorption into the circulatory system of cells or tissue), decreased litter size, and decreased fetal weights. So it’s toxic at high levels, but they are saying a small dose is okay.
In male mice, there was a dose-dependent increase in the incidence of adenomas and combined adenomas and carcinomas in the liver. So high doses can cause cancerous and non-cancerous tumors, but they are saying a small dose is okay.
It pays to read the package insert before you try any medication. Especially a medication that’s been offered on EUA and lacks long-term safety and clinical trial data. And one that has already resulted in 3,135 reports to the FDA’s adverse event reporting system, FAERS.
Remember, the EUA is supported by a Secretary of Health and Human Service (HHS) declaration that circumstances exist to justify the emergency use of drugs and biological products during the COVID-19 pandemic.
So when the pandemic is officially over, then this product will no longer be authorized for use, just like scores of other covid-related products.