Beware Pfizer’s New Antiviral COVID Treatment Drug Paxlovid | ||||||||||||||
12/30/2021 9:21:43 AM PST · by SeekAndFind · 10 replies NOQ Report ^ | 12/30/2021 | Dr. Joel S. HirschhornThe pro-drug industry mainstream media are insanely positive over the newly FDA-approved Pfizer antiviral COVID treatment pills. The drug, Paxlovid, received an emergency use authorization by FDA for use in patients 12 years old and up who have tested positive for COVID-19 and are at high risk.Now is the time to speak truth about Paxlovid. First, everyone should appreciate that there was very little testing of the short- and long-term safety of this product, exactly what happened with COVID vaccines. Really good testing of a new drug should take many months or even years.Does the public really want to take... | ||||||||||||||
PAXLOVID and Molnupiravir: Avoid | ||||||||||||||
12/23/2021 10:07:18 AM PST · by Qiviut · 35 replies Steve Kirsch's Newsletter ^ | December 23, 2021 | Steve KirschHow good is the FDA at EUA approval for COVID drugs? Well, so far, to be honest, pretty shitty. The first three Covid drugs approved under EUA were Remdesivir, Baricitinib, and Tofacitinib. All were EUA approved for inpatient use (in hospital) only, demonstrate dismal effectiveness and are replete with black box warnings and side effects such as organ failure, blood clots, serious infections and malignancy. PAXLOVID PAXLOVID was recently approved by the FDA without any external meetings or disclosure. There was no opportunity for public input. Essentially all done behind closed doors. Dr. Ryan Cole on the drug’s mechanism of...
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Paxlovid is a scary drug; here’s some prescribing information from the FDA EUA PDF:
https://www.fda.gov/media/155050/download
EUA prescribing PDF has this black box warning:
“• PAXLOVID includes ritonavir, a strong CYP3A inhibitor,
which may lead to greater exposure of certain concomitant
medications, resulting in potentially severe, life threatening, or fatal events. (4, 5.1, 7)
• Prior to prescribing PAXLOVID: 1) Review all medications
taken by the patient to assess potential drug-drug
interactions with a strong CYP3A inhibitor like PAXLOVID
and 2) Determine if concomitant medications require a dose
adjustment, interruption, and/or additional monitoring. (7)
• Consider the benefit of PAXLOVID treatment in reducing
hospitalization and death, and whether the risk of potential
drug-drug interactions for an individual patient can be
appropriately managed. (5.1, 7, 14)”
and then there’s this:
“-———————————————CONTRAINDICATIONS-—————
• History of clinically significant hypersensitivity reactions to the active ingredients (nirmatrelvir or ritonavir) or any other components. (4)
• Co-administration with drugs highly dependent on CYP3A for
clearance and for which elevated concentrations are associated with serious and/or life-threatening reactions. (4, 7.3)
• Co-administration with 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. “
and then the FDA puts this burden on prescribers:
“You or your designee must report all SERIOUS ADVERSE
EVENTS or MEDICATION ERRORS potentially related to PAXLOVID (1) by submitting FDA Form 3500 online, (2) by downloading this form and then submitting by mail or fax, or (3) contacting the FDA at 1-800-FDA-1088 to request this form. Please also provide a copy of this form to Pfizer Inc. at fax number: 1-866-635-8337. (6.4) “
[my comment: since the majority of medications metabolize via the set of CYPA hepatic enzymes, the potential for dangerous and even fatal drug interactions with Paxlovid is enormous ... we elderly are particularly vulnerable to this situation because so many of us have to take multiple medications to stay alive ... folks, even the FDA views Paxlovid as a very dangerous drug ...]