Pfizer and FDA reveal Paxlovid fails clinical trial, as FDA tries to evade its responsibility by emphasizing the drug is not approved, not even for COVID

Suddenly Pfizer’s website and the FDA want to emphasize all the problems with Paxlovid.  So in the case of this drug, these two co-conspirators apparently think that disclosures will save them from something.

Just look at this language!  Compare to the lack of disclosure of adverse effects long known to be due to the COVID vaccines.  Have you EVER heard FDA refer to the vaccines for children as unapproved?

https://www.pfizer.com/news/press-release/press-release-detail/pfizer-shares-top-line-results-phase-23-epic-pep-study

U.S. FDA Emergency Use Authorization Statement

PAXLOVID has not been approved, but has been authorized for emergency use by FDA under an EUA, for the treatment of mild-to-moderate COVID-19 in adults and pediatric patients (12 years of age and older weighing at least 40 kg) with positive results of direct SARS CoV-2 viral testing, and who are at high-risk for progression to severe COVID-19, including hospitalization or death.

The emergency use of PAXLOVID is only authorized for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of drugs and biological products during the COVID-19 pandemic under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the declaration is terminated or authorization revoked sooner.

AUTHORIZED USE

The U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) for the emergency use of the unapproved product PAXLOVID for the treatment of mild-to-moderate coronavirus disease 2019 (COVID-19) in adults and pediatric patients (12 years of age and older weighing at least 40 kg) with positive results of direct severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) viral testing, and who are at high risk for progression to severe COVID-19, including hospitalization or death.

LIMITATIONS OF AUTHORIZED USE

•    PAXLOVID is not authorized for initiation of treatment in patients requiring hospitalization due to severe or critical COVID-19
•    PAXLOVID is not authorized for use as pre-exposure or post-exposure prophylaxis for prevention of COVID-19
•    PAXLOVID is not authorized for use for longer than 5 consecutive days

PAXLOVID may only be prescribed for an individual patient by physicians, advanced practice registered nurses, and physician assistants that are licensed or authorized under state law to prescribe drugs in the therapeutic class to which PAXLOVID belongs (i.e., anti-infectives).

PAXLOVID is not approved for any use, including for use for the treatment of COVID-19.

PAXLOVID is authorized only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of PAXLOVID under 564(b)(1) of the Food Drug and Cosmetic Act unless the authorization is terminated or revoked sooner.

IMPORTANT SAFETY INFORMATION

PAXLOVID is contraindicated in patients with a history of clinically significant hypersensitivity reactions (eg, toxic epidermal necrolysis [TEN] or Stevens-Johnson syndrome) to its active ingredients (nirmatrelvir or ritonavir) or any other components of the product.

PAXLOVID is contraindicated with drugs that are highly dependent on CYP3A for clearance and for which elevated concentrations are associated with serious and/or life-threatening reactions:

•    Alpha1-adrenoreceptor antagonist: alfuzosin
•    Analgesics: pethidine, propoxyphene
•    Antianginal: ranolazine
•    Antiarrhythmic: amiodarone, dronedarone, flecainide, propafenone, quinidine
•    Anti-gout: colchicine
•    Antipsychotics: lurasidone, pimozide, clozapine
•    Ergot derivatives: dihydroergotamine, ergotamine, methylergonovine
•    HMG-CoA reductase inhibitors: lovastatin, simvastatin
•    PDE5 inhibitor: sildenafil (Revatio®) when used for pulmonary arterial hypertension
•    Sedative/hypnotics: triazolam, oral midazolam

PAXLOVID is contraindicated with drugs that are potent CYP3A inducers where significantly reduced nirmatrelvir or ritonavir plasma concentrations may be associated with the potential for loss of virologic response and possible resistance. PAXLOVID cannot be started immediately after discontinuation of any of the following medications due to the delayed offset of the recently discontinued CYP3A inducer:

•    Anticancer drugs: apalutamide
•    Anticonvulsant: carbamazepine, phenobarbital, phenytoin
•    Antimycobacterials: rifampin
•    Herbal Products: St. John’s Wort (hypericum perforatum)

There are limited clinical data available for PAXLOVID. Serious and unexpected adverse events may occur that have not been previously reported with PAXLOVID use.

Risk of Serious Adverse Reactions Due to Drug Interactions: Initiation of PAXLOVID, a CYP3A inhibitor, in patients receiving medications metabolized by CYP3A or initiation of medications metabolized by CYP3A in patients already receiving PAXLOVID, may increase plasma concentrations of medications metabolized by CYP3A. Initiation of medications that inhibit or induce CYP3A may increase or decrease concentrations of PAXLOVID, respectively. These interactions may lead to:

•    Clinically significant adverse reactions, potentially leading to severe, life-threatening, or fatal events from greater exposures of concomitant medications
•    Clinically significant adverse reactions from greater exposures of PAXLOVID
•    Loss of therapeutic effect of PAXLOVID and possible development of viral resistance

Consult Table 1 of the Fact Sheet for Healthcare Providers for clinically significant drug interactions, including contraindicated drugs. Consider the potential for drug interactions prior to and during PAXLOVID therapy; review concomitant medications during PAXLOVID therapy and monitor for the adverse reactions associated with the concomitant medications…

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Anonymous
Anonymous
4 months ago

CYP3A yet again. I will note that the shots have a similar suppressive effect on that enzyme which is necessary for clearing certain drugs.

Bob Saget was taking two such medications. The Foo Fighers drummer was supposedly on "anti-depressants" but it hasn't been revealed which ones.

This is a cruel disaster.

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