There has been a ongoing push for off-label use of certain medications to be employed in treatment of Covid-19 attributed infections. Individuals should consider current testing limitations and side effect warning before consenting to treatment with off label use drugs
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Those who follow independent media are likely aware of the severe & extensively documented flaws with all current Covid-19 testing methods. The core (PCR) test utilized to diagnosis Sars CoV-2, the virus attributed to cause Covid-19 infections, has been deemed 'useless' for detection of the virus by credible peer review conducted by twenty two relevant experts and curated by the International Consortium of Science. Two countries have ruled PCR as unreliable (Portugal & Austria) with dozens of lawsuits pending globally against the testing protocols. As this site has extensively documented the testing issues for months, this post will not delve deeply into testing issues Those who are new to the testing problems are strongly encourage to go HERE, HERE, and HERE to review Covid-19 testing method and recommendation flaws. The government public health organization and statements from Dr Anthony Fauci verify severe issues with current Covid-19 testing methods and protocols. Numerous FDA & WHO statement have been issued with protocol warnings and recalls for Covid-19 device and test kits.
Additionally, symptoms of Covid-19 attributed infections mirror symptoms of many other respiratory illnesses and disease.
Without specific and reliable testing for Sar CoV-2, there is no accurate method for determination of Covid-19 infection.
Also, review of medical research studies and autopsy evidence of early Covid-19 attributed morbidities, documents many Covd-19 deaths have resulted from bacterial infections in the blood. For a full review and documentation of this issue, please see HERE. Medical research journals have produced numerous studies indicating bacterial and fungal infections in cases of severe Covid-19 attributed infection. Deaths have been attributed to 'secondary' infections from these pathogens.
It is imperative practitioners appropriately treat actual cause of illness. Prescription of off label drugs should not be implemented without complete investigation into originating cause of illness and disease.
Additionally, there are some physicians who have advocated treating healthy individuals prophylactically with hydroxchloroquine. This makes no logical sense, as there is an incredibly low morbidity and system presentation rate with Covid-19 attributed diagnosis and there are severe health side effects documented with this medication.
Hydroxychloroquine, a anti-malarial medication with extensively documented severe side effects. Sanofi manufacturers Hydroxychloroquine, a company currently involved in the active development of new versions of Covid-19 vaccination:
"CONTRAINDICATIONS Use of PLAQUENIL is contraindicated in patients with known hypersensitivity to 4 aminoquinoline compounds.
WARNINGS Resistant strains of malaria: PLAQUENIL is not effective against chloroquine-resistant strains of P. falciparum (see CLINICAL PHARMACOLOGY – Microbiology).
Ocular: Irreversible retinal damage has been observed in some patients who had received hydroxychloroquine sulfate. Significant risk factors for retinal damage include daily doses of hydroxychloroquine sulfate greater than 6.5 mg/kg (5 mg/kg base) of actual body weight, durations of use greater than five years, subnormal glomerular filtration, use of some concomitant drug products such as tamoxifen citrate and concurrent macular disease.
A baseline ocular examination is recommended within the first year of starting PLAQUENIL. The baseline exam should include: best corrected distance visual acuity (BCVA), an automated threshold visual field (VF) of the central 10 degrees (with retesting if an abnormality is noted), and spectral domain ocular coherence tomography (SD-OCT). For individuals with significant risk factors (daily dose of hydroxychloroquine sulfate greater than 5.0 mg/kg base of actual body weight, subnormal glomerular filtration, use of tamoxifen citrate or concurrent macular disease) monitoring should include annual examinations which include BCVA, VF and SD-OCT. For individuals without significant risk factors, annual exams can usually be deferred until five years of treatment. In individuals of Asian descent, retinal toxicity may first be noticed outside the macula. In patients of Asian descent, it is recommended that visual field testing be performed in the central 24 degrees instead of the central 10 degrees. It is recommended that hydroxychloroquine be discontinued if ocular toxicity is suspected and the patient should be closely observed given that retinal changes (and visual disturbances) may progress even after cessation of therapy.
Cardiac Effects, including Cardiomyopathy and QT prolongation: Postmarketing cases of life-threatening and fatal cardiomyopathy have been reported with use of PLAQUENIL as well as with use of chloroquine. Patients may present with atrioventricular block, pulmonary hypertension, sick sinus syndrome or with cardiac complications. ECG findings may include atrioventricular, right or left bundle branch block. Signs or symptoms of cardiac compromise have appeared during acute and chronic treatment. Clinical monitoring for signs and symptoms of cardiomyopathy is advised, including use of appropriate diagnostic tools such as ECG to monitor patients for cardiomyopathy during PLAQUENIL therapy. Chronic toxicity should be considered when conduction disorders (bundle branch block/atrio-ventricular heart block) or biventricular hypertrophy are diagnosed. If cardiotoxicity is suspected, prompt discontinuation of PLAQUENIL may prevent life-threatening complications. PLAQUENIL prolongs the QT interval. Ventricular arrhythmias and torsades de pointes have been reported in patients taking PLAQUENIL (see OVERDOSAGE). Therefore, PLAQUENIL should not be administered with other drugs that have the potential to prolong the QT interval (see DRUG INTERACTIONS). Worsening of psoriasis and porphyria: Use of PLAQUENIL in patients with psoriasis may precipitate a severe attack of psoriasis. When used in patients with porphyria the condition may be exacerbated. The preparation should not be used in these conditions unless in the judgment of the physician the benefit to the patient outweighs the possible hazard. Proximal
Myopathy and Neuropathy: Skeletal muscle myopathy or neuropathy leading to progressive weakness and atrophy of proximal muscle groups, depressed tendon reflexes, and abnormal nerve conduction, have been reported. Muscle and nerve biopsies have been associated with curvilinear bodies and muscle fiber atrophy with vacuolar changes. Assess muscle strength and deep tendon reflexes periodically in patients on long-term therapy with Reference ID: 4047416
Neuropsychiatric events, including suicidality: Suicidal behavior has been rarely reported in patients treated with PLAQUENIL.
Hypoglycemia: PLAQUENIL has been shown to cause severe hypoglycemia including loss of consciousness that could be life threatening in patients treated with or without antidiabetic medications (see DRUG INTERACTIONS and ADVERSE REACTIONS). Patients treated with PLAQUENIL should be warned about the risk of hypoglycemia and the associated clinical signs and symptoms. Patients presenting with clinical symptoms suggestive of hypoglycemia during treatment with PLAQUENIL should have their blood glucose checked and treatment reviewed as necessary.
PRECAUTIONS General: Use with caution in patients with gastrointestinal, neurological, or blood disorders, and in those with a sensitivity to quinine.
Hepatic/Renal Disease: Antimalarial compounds should be used with caution in patients with hepatic disease or alcoholism or in conjunction with known hepatotoxic drugs. A reduction in dosage may be necessary in patients with hepatic or renal disease, as well as in those taking medicines known to affect these organs.
Hematologic Effects/Laboratory Tests: Antimalarial compounds should be used with caution in patients with hepatic disease or alcoholism or in conjunction with known hepatotoxic drugs. Periodic blood cell counts should be performed if patients are given prolonged therapy. If any severe blood disorder such as aplastic anemia, agranulocytosis, leukopenia, or thrombocytopenia, appears which is not attributable to the disease under treatment, consider discontinuation of PLAQUENIL. PLAQUENIL should be administered with caution in patients having glucose-6-phosphate dehydrogenase (G-6-PD) deficiency.
Dermatologic Effects: Dermatologic reactions to PLAQUENIL may occur and, therefore, proper care should be exercised when it is administered to any patient receiving a drug with a significant tendency to produce dermatitis.
Drug Interactions Digoxin: Concomitant PLAQUENIL and digoxin therapy may result in increased serum digoxin levels: serum digoxin levels should be closely monitored in patients receiving combined therapy. Insulin or antidiabetic drugs: As PLAQUENIL may enhance the effects of a hypoglycemic treatment, a decrease in doses of insulin or antidiabetic drugs may be required. Drugs that prolong QT interval and other arrhythmogenic drugs: PLAQUENIL prolongs the QT interval and should not be administered with other drugs that have the potential to induce cardiac arrhythmias. Also, there may be an increased risk of inducing ventricular arrhythmias if PLAQUENIL is used concomitantly with other arrhythmogenic drugs. Mefloquine and other drugs known to lower the convulsive threshold: PLAQUENIL can lower the convulsive threshold. Co-administration of PLAQUENIL with other antimalarials known to lower the convulsion threshold (e.g., mefloquine) may increase the risk of convulsions. Antiepileptics: The activity of antiepileptic drugs might be impaired if co-administered with PLAQUENIL. Methotrexate: Combined use of methotrexate with PLAQUENIL has not been studied and may increase the incidence of adverse effects. Cyclosporin: An increased plasma cyclosporin level was reported when cyclosporin and PLAQUENIL were co-administered. The following interactions have been observed on treatment with the structurally related substance chloroquine phosphate, and therefore cannot be ruled out for hydroxychloroquine. Praziquantel: Chloroquine has been reported to reduce the bioavailability of praziquantel. Antacids and kaolin: Antacids and kaolin can reduce absorption of chloroquine; an interval of at least 4 hours between intake of these agents and chloroquine should be observed. Cimetidine: Cimetidine can inhibit the metabolism of chloroquine, increasing its plasma level. Concomitant use of cimetidine should be avoided. Ampicillin: In a study of healthy volunteers, chloroquine significantly reduced the bioavailability of ampicillin.
Information for Patients: Patients should be informed of the early signs and symptoms of toxicity such as rash or visual changes. Patients must see their physicians promptly in case of the appearance of these or of any unusual effects. Periodic laboratory tests may be recommended in some patients. Patients should be fully informed of the potential risks of the use of PLAQUENIL, especially in pregnancy and in children. Carcinogenesis, mutagenesis, impairment of fertility: Long-term studies in animals have not been conducted to evaluate the carcinogenic potential of PLAQUENIL. The mutagenic potential of hydroxychloroquine was not evaluated. However, chloroquine has been shown to be a catalytic inhibitor of DNA repair enzymes (topoisomerase II) and to produce weak genotoxic effects through this mode of action. Reference ID: 4047416
Pregnancy Teratogenic Effects: Human pregnancies resulting in live births have been reported in the literature and no increase in the rate of birth defects has been demonstrated. Embryonic deaths and malformations of anophthalmia and microphthalmia in the offspring have been reported when pregnant rats received large doses of chloroquine. Nursing Mothers: Caution should be exercised when administering PLAQUENIL to nursing women. It has been demonstrated that hydroxychloroquine administered to nursing women is excreted in human milk and it is known that infants are extremely sensitive to the toxic effects of 4-aminoquinolines.
Pediatric Use: Safety and efficacy have not been established in the chronic use of PLAQUENIL for systemic lupus erythematosus and juvenile idiopathic arthritis in children. Children are especially sensitive to the 4-aminoquinoline compounds. Most reported fatalities followed the accidental ingestion of chloroquine, sometimes in small doses (0.75 g or 1 g in one 3-year-old child). Patients should be strongly warned to keep these drugs out of the reach of children (see OVERDOSAGE). Geriatric Use: Clinical studies of PLAQUENIL did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. However, this drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection and it may be useful to monitor renal function.
ADVERSE REACTIONS The following adverse reactions have been identified during post-approval use of PLAQUENIL or other 4-aminoqunoline compounds. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Blood and lymphatic system disorders: Bone marrow failure, anemia, aplastic anemia, agranulocytosis, leukopenia, and thrombocytopenia. Hemolysis reported in individuals with glucose-6-phosphate dehydrogenase (G-6-PD) deficiency. Cardiac disorders: Cardiomyopathy which may result in cardiac failure and in some cases a fatal outcome (see WARNINGS and OVERDOSAGE). PLAQUENIL prolongs the QT interval. Ventricular arrhythmias and torsade de pointes have been reported in patients taking PLAQUENIL (see OVERDOSAGE and DRUG INTERACTIONS). Ear and labyrinth disorders: Vertigo, tinnitus, nystagmus, nerve deafness, deafness. Eye disorders: Irreversible retinopathy with retinal pigmentation changes (bull’s eye appearance), visual field defects (paracentral scotomas) and visual disturbances (visual acuity), maculopathies (macular degeneration), decreased dark adaptation, color vision abnormalities, corneal changes (edema and opacities) including corneal deposition of drug with or without accompanying symptoms (halo around lights, photophobia, blurred vision). Gastrointestinal disorders: Nausea, vomiting, diarrhea, and abdominal pain. General disorders and administration site conditions: Fatigue. Hepatobiliary disorders: Liver function tests abnormal, hepatic failure acute. Immune system disorders: Urticaria, angioedema, bronchospasm Metabolism and nutrition disorders: Decreased appetite, hypoglycemia, porphyria, weight decreased. Musculoskeletal and connective tissue disorders: Sensorimotor disorder, skeletal muscle myopathy or neuromyopathy leading to progressive weakness and atrophy of proximal muscle groups, depression of tendon reflexes and abnormal nerve conduction. Nervous system disorders: Headache, dizziness, seizure, ataxia and extrapyramidal disorders such as dystonia, dyskinesia, and tremor have been reported with this class of drugs. Psychiatric disorders: Affect/emotional lability, nervousness, irritability, nightmares, psychosis, suicidal behavior. Skin and subcutaneous tissue disorders: Rash, pruritus, pigmentation disorders in skin and mucous membranes, hair color changes, alopecia. Dermatitis bullous eruptions including erythema multiforme, Stevens-Johnson syndrome, and toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS syndrome), photosensitivity, dermatitis exfoliative, acute generalized exanthematous pustulosis (AGEP). AGEP has to be distinguished from psoriasis, although PLAQUENIL may precipitate attacks of psoriasis. It may be associated with pyrexia and hyperleukocytosis. To report SUSPECTED ADVERSE REACTIONS, contact Concordia Pharmaceuticals Inc. at 1-877-370-1142 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. OVERDOSAGE The 4-aminoquinoline compounds are very rapidly and completely absorbed after ingestion, and in accidental overdosage, or rarely with lower doses in hypersensitive patients, toxic symptoms may occur within 30 minutes. The symptoms of overdosage may include headache, drowsiness, visual disturbances, cardiovascular collapse, convulsions, hypokalemia, rhythm and conduction disorders including QT prolongation, torsades de pointes, ventricular tachycardia and ventricular fibrillation, followed by sudden potentially fatal respiratory and cardiac arrest. Treatment is symptomatic and must be prompt. Immediate gastric lavage until the stomach is completely emptied is indicated. After lavage, activated charcoal is introduced by the stomach tube within 30 minutes of ingestion of the drug may inhibit further intestinal absorption. To be effective, the dose of activated charcoal should be at least five times the estimated dose of hydroxychloroquine ingested. Consideration should be given to administering diazepam parenterally since studies suggest that it may be beneficial in reversing chloroquine and hydroxychloroquine cardiotoxicity. Respiratory support and shock management should be instituted as necessary. Exchange transfusions are used to reduce the level of 4-aminoquinoline drug in the blood. A patient who survives the acute phase and is asymptomatic should be closely observed for at least six hours. Fluids may be forced and sufficient ammonium chloride (8 g daily in divided doses for adults) may be administered for a few days to acidify the urine. This will promote urinary excretion in cases of both overdosage and sensitivity. However, caution must be exercised in patients with impaired renal function and/or metabolic acidosis".
All current proposed Covid-19 adjunct medication treatments have documented risk of severe side effects.
Remdesivir has been studied and currently employed as a drug treatment for severe Covid-19 attributed infections with the FDA approving the drug last October for off label use for Covid-19 treatment.
Review of package insert and drug side effect for remdesivir:
For Healthcare Professionals
Applies to remdesivir: intravenous powder for injection, intravenous solution
General
The most common side effect in healthy subjects was increased transaminases. The most common side effects in patients with coronavirus disease 2019 (COVID-19) were nausea, increased AST, and increased ALT.[Ref]
Hepatic
In studies in healthy subjects, increases in ALT, AST, or both in those who received this drug were grade 1 (10%) or grade 2 (4%). In a clinical study of patients with COVID-19, the incidence of at least grade 3 nonserious side effects of increased aminotransferase levels (including ALT, AST, or both) was 4% with this drug compared to 6% with placebo. In a clinical trial in hospitalized patients with severe COVID-19 receiving this drug for 5 or 10 days, any grade (at least 1.25 times the upper limit of normal [1.25 x ULN]) laboratory abnormalities of increased AST and increased ALT were reported in 40% and 42% of patients, respectively; at least grade 3 (at least 5 x ULN) laboratory abnormalities of increased AST and increased ALT were both reported in 7% of patients. In a clinical trial in hospitalized patients with moderate COVID-19 receiving this drug for 5 or 10 days compared to standard of care, any grade laboratory abnormalities of increased AST and increased ALT occurred in 32% and 33% of patients, respectively, receiving this drug and 33% and 39% of patients, respectively, receiving standard of care; at least grade 3 laboratory abnormalities of increased AST and increased ALT occurred in 2% and 3% of patients, respectively, receiving this drug and 6% and 7%, respectively, receiving standard of care.[Ref]
Very common (10% or more): Increased transaminases, increased ALT, increased AST
Common (1% to 10%): Increased aminotransferase levels (including ALT, AST, or both), increased bilirubin
Uncommon (0.1% to 1%): Increased hepatic enzyme, hypertransaminasemia, increased liver function tests[Ref]
Renal
Very common (10% or more): Decreased CrCl (based on Cockcroft-Gault formula; up to 19%), decreased estimated glomerular filtration rate (eGFR; up to 18%), increased creatinine (up to 15%)
Uncommon (0.1% to 1%): Decreased GFR, acute kidney injury[Ref]
Hematologic
Very common (10% or more): Decreased hemoglobin (up to 15%), decreased lymphocytes (up to 11%)
Common (1% to 10%): Increased prothrombin time[Ref]
Metabolic
Very common (10% or more): Increased glucose (up to 12%)[Ref]
Gastrointestinal
Common (1% to 10%): Nausea[Ref]
Nervous system
Common (1% to 10%): Headache
Uncommon (0.1% to 1%): Seizure
Frequency not reported: Generalized seizure[Ref]
Dermatologic
Common (1% to 10%): Rash
Frequency not reported: Angioedema[Ref]
Other
Uncommon (0.1% to 1%): Infusion-related reactions, increased blood alkaline phosphatase[Ref]
Cardiovascular
Uncommon (0.1% to 1%): Decreased heart rate
Off label medical use of the above medications for Covid-19 treatment comes with risks of serious side effects. Current testing methods are non-specific for Sars CoV2 with no reliable diagnostic method available to differentiate Covid-19 attributed symptoms to those resulting from of illness and disease. Extensive contraindications for use in concurrent health conditions could result in harm, if illness is resulting from a illness with a listed manufacture warning. Additionally, all medical studies for drug and vaccine therapies for treatment or preventions of Covid-19 infections employing PCR testing to determine diagnosis of initial Covid-19 infection and determine end point outcomes have severely corrupted and unreliable results.
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