Scam Alert for Hydroxychloroquine (Sanofi-Pasteur’s Plaquenil) as a Potential (but not Totally Rational), Off-Label Drug to Use for Coronavirus Infections
By Gary G. Kohls, MD - March 22, 2020 (2760 words)
While trying to understand the recent propaganda push that has been mentioned so often by every mainstream media outlet (as well as from every White House podium) regarding hydroxychloroquine/Plaquenil, the old Sanofi-Pasteur drug that is only approved by the FDA for malaria, I became suspicious that there was more to the propaganda than meets the eye.
So, I did some research of the literature and summarized some of the adverse effects of the drug directly from the Sanofi website. What I discovered about this very dangerous drug is summarized further below.
If Sanofi, France’s largest pharmaceutical corporation, has anything to do with it, Plaquenil will likely be widely prescribed as an experimental, unapproved, off-label drug for many of the victims of the coronavirus epidemic – world-wide. The company is highly likely to make billions of dollars on this old drug, given the current level of hysteria that has been generated by the Big Pharma paymaster that control the media and many of the bureaucratic institutions that seem to be in charge of creating the hysteria.
It is important to be fully aware that the FDA has not adequately tested for the drug’s safety or effectiveness in coronavirus patients. But, by hook or by crook, hydroxychloroquine will be successfully pushed on the unsuspecting public as a “compassionate-use” agent for anybody suspected as having a coronaviral infection, even if the patient might only have a common cold! One can expect that people with mild symptoms will be demanding to be placed on the drug.
Please read the information below from Sanofi-Pasteur’s very conveniently re-published “revised document” (which physicians won’t be likely to read and therefore their innocent and unaware patients will never be informed about the potential adverse effects or toxicity prior to being harmed by the drug).
Interestingly the document was published on August 26, 2019, 2 months before the “By Invitation Only” Event 201 (October 18), which was organized by the Bill & Melinda Gates Foundation, Johns Hopkins University and the World Economic Forum. At that event, the invitees predicted a coming viral pandemic and – lo and behold - four months later, the “predicted” coronavirus epidemic began in China.
One doesn’t have to be very paranoid to wonder if Sanofi or other pharmaceutical corporations benefitted in some way by being behind the scenes. Somebody should look at the investment activities and stock prices of the involved corporate entities.
According to information published on Google, an average cost for un-insured patients for sixty 200 mg tablets of Plaquenil can be as high as $654!! This for a drug that used to cost only pennies in the distant past. Of course, today generic hydroxychloroquine will cost less than Plaquenil, but surely the prices of both branded and generic drugs will be raised substantially (gouging the patient) with any increased demand. $654 is hardly the “cheap” cost professed by Dr. Fauci, et al., who have un-declared conflicts of interest with the drug industry and likely own shares of Big Pharma companies.
The following information is excerpted from http://products.sanofi.ca/en/plaquenil.pdf. Despite the ease in obtaining this information, most physicians – and most patients as well - will still be likely to sucker for the Sanofi propaganda and eagerly start using this very dangerous, experimental drug. Aware patients need to become knowledgeable about the potential consequences of taking this drug even before their doctor starts writing the prescription.
HYDROXYCHLOROQUINE/PLAQUENIL: ADVERSE REACTIONS, WARNINGS AND PRECAUTIONS
Very common ≥ 10 %; Common ≥ 1 and < 1 %; Rare ≥ 0.01 and < 0.01 %; Not known (ie, frequency cannot be estimated from available data).
Chronic toxicity should be considered when conduction disorders (bundle branch block/ atrioventricular heart block) as well as biventricular hypertrophy are found. Drug discontinuation may lead to recovery PLAQUENIL prolongs the QT, PR and/or QRS intervals which may lead to an arrhythmia. Ventricular arrhythmias and torsade de pointes have been reported in patients taking PLAQUENIL
Ear and labyrinth disorders:
Uncommon: Vertigo, tinnitus.
Common: Blurring of vision due to a disturbance of accommodation which is dose dependent and reversible/
Uncommon: Maculopathies, which may be irreversible. Retinopathy with changes in pigmentation and visual field defects. In its early form it appears reversible upon discontinuation of the drug. If allowed to develop however, there may be a risk of progression even after treatment withdrawal. Patients with retinal changes may be asymptomatic initially, or may have scotomatous vision with paracentral, pericentral ring types, temporal scotomas, abnormal colour visions, reduction in visual acuity, night blindness, difficulty reading and skipping words.
Corneal changes including edema and opacities. They are either symptomless or may cause disturbances such as halos around lights especially at night, blurring of vision, vision disturbances, or photophobia. They may be transient or are reversible upon discontinuation of therapy
Very common: Abdominal pain, nausea.
Common: Diarrhea, vomiting.
Hepatobiliary (liver and bile duct) disorders:
Uncommon: Abnormal liver function tests.
Metabolism and nutrition disorders :
Common: Anorexia (usually resolves immediately upon reducing the dose or upon stopping the treatment),
Endocrine and Metabolism:
PLAQUENIL may exacerbate porphyria.
Musculoskeletal and connective tissue disorders
Uncommon: Sensory motor disorders.
Depression of tendon reflexes, abnormal results of nerve conduction tests.
Myopathy may be reversible after drug discontinuation, but recovery may take many months.
Nervous system disorders
Common: Affect lability.
Skin and subcutaneous tissue disorders:
Common: Skin rash, pruritus.
Uncommon: Pigmentary changes in skin and mucous membranes, bleaching of hair, alopecia. These usually resolve readily upon cessation of therapy.
Observe caution in patients with gastrointestinal or neurological disorders, in those with sensitivity to quinine, and in porphyria.
Effects on Ability to Drive and Use Machinery:
Patients should be warned about driving and operating machinery since PLAQUENIL can impair accommodation and cause blurring of vision.
Carcinogenesis and Mutagenesis:
Non-clinical studies showed a potential risk of chloroquine inducing gene mutations. In humans, there are insufficient data to rule out an increased risk of cancer in patients receiving-long term treatment.
Cases of cardiomyopathy resulting in cardiac failure, in some cases with a fatal outcome, have been reported in patients treated with PLAQUENIL. PLAQUENIL should be discontinued if signs and symptoms of cardiomyopathy develop. Chronic toxicity should be considered when conduction disorders (bundle branch block/atrio-ventricular heart block) as well as biventricular hypertrophy is diagnosed
Electrocardiogram (ECG) Changes and Potential for Cardiac Arrhythmias:
PLAQUENIL can prolong the PR, QRS and QTc intervals, especially in patients with underlying risk factors. Serious adverse events, including fatal outcomes, have been reported in patients taking PLAQUENIL including ventricular arrhythmias, heart blocks, ventricular fibrillation and torsade de pointes QTc prolongation may lead to an increased risk of ventricular arrhythmias including torsade de pointes. Torsade de pointes may be asymptomatic or experienced by the patient as dizziness, palpitations, syncope, or seizures. If sustained, torsade de pointes can progress to ventricular fibrillation and sudden cardiac death. Permanently discontinue PLAQUENIL in patients who develop torsade de pointes or polymorphic ventricular tachycardia or signs/symptoms of serious arrhythmia. If cardiac complications due to PLAQUENIL are suspected, treatment should be discontinued.
PLAQUENIL is not recommended for use in patients with baseline QTc prolongation (e.g., congenital or acquired Long QT Syndrome), second-or third-degree atrioventricular block. Electrolyte imbalances (e.g. hypokalemia/hypomagnesemia/hypocalcemia) must be corrected prior to use.
Use of PLAQUENIL should be undertaken with extreme caution in patients with other risk factors for torsade de pointes.
Risk factors for torsade de pointes:
In the general population include: female gender; age ≥ 65 years; baseline prolongation of the QT/QTc interval; presence of genetic variants affecting cardiac ion channels or regulatory proteins, especially congenital long QT syndromes; family history of sudden cardiac death.
Endocrine and Metabolism:
PLAQUENIL has been shown to cause severe hypoglycemia including loss of consciousness that could be life threatening in patients treated with and without antidiabetic medications. 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 level checked and the need for PLAQUENIL treatment reviewed as necessary.
In cases of severe hypoglycemia, PLAQUENIL should be discontinued and alternative therapy considered. If patients use PLAQUENIL concomitantly with antidiabetic drugs, a decrease in doses of insulin or antidiabetic drugs may be required as PLAQUENIL may enhance the effects of hypoglycemic treatment.
Periodic blood counts should be obtained in patients requiring prolonged therapy due to the risk of bone marrow depression. If any severe blood disorder appears that is not attributable to the disease under treatment, the drug should be discontinued. Observe caution in patients with blood disorders or glucose-6-phosphate dehydrogenase deficiency.
Hepatic (liver)/Biliary (bile ducts)/Pancreatic:
PLAQUENIL should be used with caution in patients with hepatic disease or alcoholism, in whom a reduction in dosage may be necessary, or in conjunction with known hepatotoxic drugs. Use of PLAQUENIL in patients with hepatic impairment as well as with concomitant CYP2C8 or CYP3A4 inhibitors can result in elevation of hydroxychloroquine plasma concentrations, with the magnitude of the effect depending on the degree of hepatic impairment, as well as the enzyme inhibited and the potency of the inhibitor. Isolated cases of abnormal liver function tests as well as fulminant hepatic failure have been reported.
All patients on long term therapy with this preparation should be questioned and examined periodically, including the examination of skeletal muscle function and tendon reflexes, testing of knee and ankle reflexes, to detect any evidence of muscular weakness. If weakness occurs, discontinue the drug.
Extrapyramidal reactions have been reported in patients taking PLAQUENIL Symptoms may persist in some patients after discontinuation of therapy.
Irreversible retinal damage has been observed in some patients who had received long-term or high-dosage 4-aminoquinoline therapy for discoid and systemic lupus erythematosus, or rheumatoid arthritis. Before starting a long-term treatment, both eyes should be examined by careful ophthalmoscopy for visual acuity, central visual field and colour vision, and fundoscopy. Then, the examination should be repeated at least annually.
Retinal toxicity is largely dose-related. The risk of retinal damages is small with daily doses of up to 6.5 mg/kg ideal (lean) body weight. Exceeding the recommended daily dose sharply increases the risk of retinal toxicity. Significant risk factors for toxic retinopathy reported during long-term (≥5 years) treatment with hydroxychloroquine include daily doses greater than 6.5 mg/kg (5 mg/kg base) of actual body weight, subnormal glomerular filtration rate, durations of use longer than five years, and concurrent treatment with tamoxifen citrate. Concomitant use of PLAQUENIL with drugs known to induce retinal toxicity, such as tamoxifen, is not recommended. Careful ophthalmologic examination should be more frequent and adapted to the patient, in the following situations: - daily doses exceeding 6.5 mg (salt form)/kg ideal (lean) body weight. Absolute body weight used as a guide to dosage, could result in an overdosage in the obese; - renal insufficiency; - cumulative dose more than 200 g (salt form); - elderly; - impaired visual acuity. If there is any indication of abnormality in the visual acuity, visual field, or retinal macular areas (such as pigmentary changes, loss of foveal reflex), or any visual symptoms (such as light flashes and streaks, abnormal colour vision) that are not fully explainable by difficulties of accommodation or corneal opacities, the drug should be stopped immediately. The patient should be closely observed for possible progression of the abnormality. Retinal changes (and visual disturbances) may progress even after cessation of the therapy. Methods recommended for early diagnosis of retinopathy consist of (1) funduscopic examination of the macula for fine pigmentary disturbances or loss of the foveal reflex and (2) examination of the central visual field with a small red test object for pericentral or paracentral scotoma or determination of retinal thresholds to red. Any unexplained visual symptoms, such as light flashes or streaks also should be regarded with suspicion as possible manifestations of retinopathy.
Suicidal behaviour has been reported in patients treated with PLAQUENIL.
Observe caution in patients with renal disease, in whom a reduction in dosage may be necessary, as well as in those taking medicines known to affect this organ. During treatment and after discontinuation, monitoring for adverse reactions may be warranted in patients with severe renal impairment or end-stage renal disease (ESRD), given the long half-life of hydroxychloroquine.
Dermatological reactions to PLAQUENIL may occur. It is not recommended for the treatment of psoriasis or porphyria as these conditions may be exacerbated by its use. Observe caution in patients with psoriasis. PLAQUENIL may cause acute generalized exanthematous pustulosis (AGEP). AGEP has to be distinguished from psoriasis, although PLAQUENIL may precipitate attacks of psoriasis. It may be associated with fever and hyperleukocytosis. Outcome is usually favorable after discontinuation of drug. Sexual Health: Fertility: Animal studies showed an impairment of male fertility with chloroquine treatment. There are no data in humans.
Hydroxychloroquine crosses the placenta. Data are limited regarding the use of PLAQUENIL during pregnancy. PLAQUENIL should be avoided in pregnancy. It should be noted that the 4- aminoquinolines in therapeutic doses have been associated with central nervous system damage, including ototoxicity (auditory and vestibular toxicity, congenital deafness), retinal hemorrhages and abnormal retinal pigmentation to the foetus. Embryonic deaths and ocular malformations in the offspring have been reported when pregnant rats received large doses of chloroquine.
Careful consideration should be given to using PLAQUENIL during breastfeeding, since it is excreted in small amounts (approximately 2% of the maternal dose after bodyweight correction) in human breast milk and it is known that infants are extremely sensitive to the toxic effects of 4- aminoquinolines. There are very limited data on the safety in the breastfed infant during hydroxychloroquine long-term treatment. The prescriber should assess the potential risks and benefits of use during breastfeeding, according to the indication and duration of treatment. Although hydroxychloroquine is excreted in breast milk, the amount is insufficient to confer any protection against malaria to the infant. Separate chemoprophylaxis for the infant is required.
Safety and efficacy has not been established in rheumatoid arthritis or systemic lupus erythematosus in children. Children are especially sensitive to the 4-aminoquinoline compounds. The most reported fatalities follow the accidental ingestion of chloroquine, sometimes in small doses. Patients should be strongly warned to keep these drugs out of the reach of children.
PLAQUENIL should be used with caution in patients with hepatic disease or alcoholism, in whom a reduction in dosage may be necessary, or in conjunction with known hepatotoxic drugs. Isolated cases of abnormal liver function tests as well as fulminant hepatic failure have been reported.
PLAQUENIL should be used with caution in patients with renal disease, in whom a reduction in dosage may be necessary, as well as in those taking medicines known to affect this organ.
Monitoring and Laboratory Tests:
ECG assessments are recommended at baseline and periodically during treatment with PLAQUENIL. More frequent monitoring is recommended if PLAQUENIL is administered to patients with baseline ECG abnormalities or who are being treated concomitantly with other QTc-, QRS-, or PR-interval prolonging drugs. Monitor electrolytes regularly.
Only limited preclinical data are available for hydroxychloroquine, therefore chloroquine data are considered due to the similarity of structure and pharmacological properties between the 2 products.
Genotoxicity (genetic damage):
There are limited data on hydroxychloroquine genotoxicity. Chloroquine is reported in the literature to be a weak genotoxic agent which may elicit both gene mutations and chromosomal/DNA breaks. Mechanisms may involve DNA intercalation or induction of oxidative stress. Positive and negative results were observed in in vitro reverse gene mutation assays using bacteria (Ames test) and in in vivo studies using rodents (mouse bone marrow cell sister chromatid exchange, mouse bone marrow cell chromosome abnormality, and rat DNA strand-breaks in multiple organs when animals were dosed by intraperitoneal route).
There are no data on hydroxychloroquine carcinogenicity from animal studies and insufficient data on carcinogenicity is available for chloroquine. Both drugs are not classifiable as to their carcinogenicity to humans.
Reproductive and developmental toxicity:
There are limited data on hydroxychloroquine teratogenicity. Supratherapeutic doses of chloroquine resulted in a fetal mortality rate of 25% and ocular malformations in 45% of fetuses. Autoradiographic studies have shown that when administered at the start or the end of gestation, chloroquine accumulates in the eyes and ears. There are no data on hydroxychloroquine action on fertility.