Safety Data Indicates Drug Interactions with Paxlovid Overstated
Paxlovid (nirmatrelvir tablets; ritonavir tablets), is the only oral agent officially endorsed by HHS, NIH, CDC, FDA for the ambulatory treatment of COVID-19
It has been undermined by concerns regarding drug-drug interactions (DDI) as well as “rebound” or an extension of the illness with abbreviated use.
My clinical impression is that the drug is reasonably safe but only modestly effective.
It appears to be slow-onset and only partially helpful as the an antiviral in the McCullough Protocol. As a clinician who has used all of the drugs in the protocol, my preferred antiviral is ivermectin 0.6 mg/kg per day for 5-30 days.
Bihan and coworkers analyzed the the BNPV pharmacovigilance database (N=12,179) which is administered by the Agence nationale desécurité du médicament et des produits de santé (ANSM), sponsored by the French Health Agency.
There were 30 cases of DDI. Most of the interactions occurred in presumably transplant patients on tacrolimus or similar drugs.
For the non-immunosuppressant cases the vignettes and outcomes were predictable and manageable.
In summary, despite theoretical concerns of DDI with paxlovid, the clinical reality for the brief course of treatment is reassuring.
Despite its shortcomings, this drug can be used most appropriately in the context of a multidrug protocol in the treatment of acute ambulatory COVID-19.
It should not be considered for monotherapy.
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Tom
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Bullcrap!
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Whokoo
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Tom!!! Your language!!!
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NecktopPC
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Re: “My clinical impression is that the drug is reasonably safe but only modestly effective”.
PAXLOVID- nirmatrelvir and ritonavir
Original EUA Authorized Date: 12/2021
Revised EUA Authorized Date: 02/2023
LIMITATIONS OF AUTHORIZED USE
PAXLOVID is not approved for any use, including for use for the treatment of COVID-19.
5 WARNINGS AND PRECAUTIONS
There are limited clinical data available for PAXLOVID. Serious and unexpected adverse events may occur that have not been previously reported with PAXLOVID use.
6.4 Required Reporting for Serious Adverse Events and Medication Errors
The prescribing healthcare provider and/or the provider’s designee is/are responsible for MANDATORY REPORTING of all serious adverse events3 and medication errors potentially related to PAXLOVID within 7 calendar days from the healthcare provider’s awareness of the event, using FDA Form 3500.
Serious adverse events are defined as:
• Death;
• A life-threatening adverse event;
• Inpatient hospitalization or prolongation of existing hospitalization;
• A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions;
• A congenital anomaly/birth defect;
• Other important medical event, which may require a medical or surgical intervention to prevent death, a life-threatening event, hospitalization, disability, or congenital anomaly.
8.1 Pregnancy
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.\
The estimated background risk of major birth defects and miscarriage for the indicated population is unknown.
8.2 Lactation
There are no available data on the presence of nirmatrelvir in human or animal milk, the effects on the breastfed infant, or the effects on milk production.
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
Carcinogenicity studies have not been conducted with nirmatrelvir.
https://labeling.pfizer.com/ShowLabeling.aspx?id=16474
NIH – U.S. National Library of Medicine
ClinicalTrials.gov.
Paxlovid for Treatment of Long Covid (STOP-PASC)
Actual Study Start Date: November 8, 2022
Estimated Primary Completion Date: September 2023
Estimated Study Completion Date: November 2023
https://clinicaltrials.gov/ct2/show/NCT05576662
Symptoms of COVID-19:
Fever or chills
Cough
Shortness of breath or difficulty breathing
Fatigue
Muscle or body aches
Headache
New loss of taste or smell
Sore throat
Congestion or runny nose
Nausea or vomiting
Diarrhea
https://www.cdc.gov/coronavirus/2019-ncov/symptoms-testing/symptoms.html
Symptoms of INFLUENZA:
Fever
Aching muscles
Chills and sweats
Headache
Dry, persistent cough
Shortness of breath
Tiredness and weakness
Runny or stuffy nose
Sore throat
Eye pain
Vomiting and diarrhea, but this is more common in children than adults
https://www.mayoclinic.org/diseases-conditions/flu/symptoms-causes/syc-20351719
November 7, 2018 – Can The Flu Permanently Damage Your Sense of Smell?
According to the Mayo Clinic, any condition that obstructs your nasal passage or flow of air through your nose can cause you to lose your sense of smell. The medical term for a complete loss of smell is anosmia, while a partial loss of smell is called hyposmia.
These conditions include:
The common cold
The flu
Sinusitis
Chronic congestion
Nasal polyps
There are also neurological conditions that can cause anosmia. Although uncommon…
Alzheimer’s disease
A brain tumor
Head injury
Diabetes
Exposure to harmful chemicals such as insecticides
Certain medications
Zinc-containing nasal sprays (these have been taken off the market)
https://www.raleighcapitolent.com/blog/lost-sense-of-smell
3 years later they admit it was the flu along.
https://rumble.com/v2j2wm2-3-years-later-they-admit-it-was-the-flu-along..html
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