Posted on 04/10/2020 10:54:51 AM PDT by SeekAndFind
The drug doesn't come without a certain set of risks, and no one knows if it can effectively treat COVID-19.
The president and some of his close advisors — desperate for a COVID-19 cure — are asking “What do you have to lose?” by taking hydroxychloroquine (HCQ), a strong medication never adequately tested for efficacy or safety in COVID-19 patients. The correct answer to the president’s question, which he doesn’t seem to want to hear, is that we have our lives to lose.
The president acknowledges “I’m not a doctor” but this raises the question “What do doctors know about the drug recommended by the president?" Most doctors are aware that HCQ can be effective for patients with malaria, arthritis or lupus. If they were to follow the president’s suggestion and prescribe it for COVID-19 patients, they would also like to know that it will benefit some of those patients, at least.
This drug hasn't proven to be successful in treating viral illnesses
What is known? HCQ has been tested previously in several viral illnesses but never found effective. Importantly, there is no evidence whatsoever that HCQ can prevent COVID-19, and there is only anecdotal evidence that it improves the course of the disease. The reports that it can reduce the measurable levels of the virus in patients are seriously flawed, lack a valid control group and were released to the public with little, if any, scientific review. Proper clinical trials with HCQ are underway, but these will take months. In summary, doctors do not know if HCQ or any other drug now being tested is effective or will have any medical benefit.
Without any assurance of benefit, what do you have to lose? Most doctors rely on the FDA-approved label to evaluate the “risk” side of the benefit/risk equation for each presciption. The drug label for HCQ, and its close relative Chloroquine, are very clear about their risks and both contain a page and a half of stark warnings that include the possibility of blindness due to retinal injury, loss of consciousness due to low blood sugar, suicidal behavior, heart failure, potentially lethal interactions with other drugs, lethal heart rhythm disturbances and yes, death. When doctors prescribe HCQ, they expect that the risk of these potentially tragic side effects will be outweighed by some benefit.
Doctors are also trained to use their medical skills to evaluate the patient’s overall condition as part of the risk/benefit equation for a drug and to take appropriate measures to mitigate any risks. They know that some patients are at greater risk of developing side effects than others. Unfortunately, the patients at greatest risk for most of HCQ’s serious side effects are the same as the very sickest COVID-19 patients, e.g. those on respirators with low blood oxygen levels and with disturbances in body chemistry.
Continuous ECG monitoring is one of the methods used to prevent potentially lethal cardiac effects of HCQ and chloroquine. In many ICUs, computerized decision support systems monitor the patient’s electronic chart and send advisories to physicians when a drug’s risk exceeds safe thresholds. However, these surveillance tools are not generally available outside of the hospital and could not protect those who might try to prevent COVID-19 by taking HCQ.
Special exceptions are made for emergencies
Pandemics and other public health tragedies alter the usual norms and requirements of medical practice. When a life is in danger, physicians may decide to prescribe an unproven drug and monitor the patient for any potentially serious side effects. To enable such use, the FDA has “approved” the careful use of HCQ under an Emergency Use Authorization (EUA). It should be emphasized that the FDA did not approve HCQ as either safe or effective to treat or prevent COVID-19. Recognizing the unique situation doctors are facing, the FDA’s emergency authorization is for the “unapproved use of hydroxychloroquine” supplied from the nation’s stockpile but only for hospitalized adults and adolescents “for whom a clinical trial is not available, or participation is not feasible”.
The FDA’s EUA Fact Sheet should be carefully read by anyone contemplating prescribing or taking HCQ. Also, the public should know that the FDA is working hard to correct a problem at some public websites that post drug labels. Labels for 15 of the 49 products containing HCQ are out of date and do not contain the warnings found in the currently approved HCQ label or in the FDA’s Fact sheet.
In this crisis, our political leaders are grasping at straws and encouraging hope. When faced with a national medical crisis such as a pandemic, I encourage our leaders to defer to the medical and scientific experts who have the knowledge, skills and training to save lives and to not encourage unnecessary or unfounded risks with our lives and our safety.
Dr. Raymond L. Woosley is a professor of medicine at The University of Arizona, College of Medicine-Phoenix. He is the president of the Arizona Center for Education and Research on Therapeutics.
So do Big Macs.
It more dangerous to drive on a crowded highway than take this drug when monitored by your doc.
Even my liberal friends are sick of these kind of articles!
Oh, yes. There was bowl full of them right when you walked in to eat. They were white and we took them once a day at breakfast, as best I can remember. Then, once a week we took another pill; I believe it was red or maybe orange. I don’t remember the name of the drug.
And yet, my S-I-L has been taking it for nearly twenty years for Lupus.
This is a list of side effects to hydroxychoroquine from UpToDate that I posted the other day on a different thread. I encourage you to read through them all.
Hydroxychloroquine may have some benefit for COVID-19 and is being used in this time of national emergency under medical supervision but definitive trials remain pending.
As a practicing neurologist (epileptologist) with over 30 years experience I have used my share of problematic medications (felbamate, ezogabine, valproate, lamotrigine, topiramate, everolimus) but even from my perspective this is not a list of side effects to consider lightly. Fortunately many of these are more likely to be a problem with long term use but while that is not an issue with treatment of COVID-19 it will be use for prevention is considered.
Adverse Reactions
1% to 10%: Ophthalmic: Retinopathy (4%; serum concentration dependent [Petri 2019]; early changes reversible [may progress despite discontinuation if advanced])
Frequency not defined:
Dermatologic: Acute generalized exanthematous pustulosis, alopecia, bullous rash, dyschromia (skin and mucosal), erythema multiforme, exacerbation of psoriasis, exfoliative dermatitis, hair discoloration, pruritus, skin photosensitivity, skin rash, Stevens-Johnson syndrome, toxic epidermal necrolysis, urticaria
Endocrine & metabolic: Exacerbation of porphyria, severe hypoglycemia, weight loss
Gastrointestinal: Abdominal pain, decreased appetite, diarrhea, nausea, vomiting
Hematologic & oncologic: Agranulocytosis, anemia, aplastic anemia, bone marrow failure, hemolysis (in patients with glucose-6-phosphate deficiency), leukopenia, thrombocytopenia
Hepatic: Abnormal hepatic function tests, acute hepatic failure
Hypersensitivity: Angioedema
Immunologic: Drug reaction with eosinophilia and systemic symptoms
Nervous system: Ataxia, dizziness, emotional lability, fatigue, headache, irritability, nervousness, nightmares, psychosis, seizure, sensorineural hearing loss, suicidal tendencies, vertigo
Neuromuscular & skeletal: Myopathy (including palsy or neuromyopathy, leading to progressive weakness and atrophy of proximal muscle groups; may be associated with mild sensory changes and loss of deep tendon reflexes)
Ophthalmic: Corneal changes (corneal edema, corneal opacity, corneal sensitivity, corneal deposits, visual disturbance, blurred vision, photophobia), decreased visual acuity, macular degeneration, maculopathy, nystagmus disorder, retinal pigment changes, retinitis pigmentosa, scotoma, vision color changes, visual field defect
Otic: Deafness, tinnitus
Respiratory: Bronchospasm
Postmarketing:
Cardiovascular: Cardiomyopathy, prolonged QT interval on ECG, torsades de pointes, ventricular arrhythmia
Endocrine & metabolic: Hypoglycemia (can be severe; Cansu 2008; FDA Safety Alert, April 1, 2020; Unübol 2011)
Hematologic & oncologic: Neutropenia (FDA Safety Alert, April 1, 2020), pancytopenia (FDA Safety Alert, April 1, 2020)
Nervous system: Agitation (FDA Safety Alert, April 1, 2020), confusion (FDA Safety Alert, April 1, 2020), delirium (FDA Safety Alert, April 1, 2020), extrapyramidal reaction (FDA Safety Alert, April 1, 2020), hallucination (FDA Safety Alert, April 1, 2020)
Ophthalmic: Epithelial keratopathy (Dosso 2007)
Renal: Renal insufficiency (FDA Safety Alert, April 1, 2020)
Warnings/Precautions
Concerns related to adverse effects:
• Cardiovascular effects: Cardiomyopathy resulting in cardiac failure, sometimes fatal, has been reported (symptoms may present as atrioventricular block, pulmonary hypertension, sick sinus syndrome, or as cardiac complications), and may appear during acute or chronic therapy. Monitor for signs/symptoms of cardiac compromise; discontinue treatment promptly if signs and symptoms of cardiomyopathy occur. In a scientific statement from the American Heart Association, hydroxychloroquine has been determined to be an agent that may either cause direct myocardial toxicity or exacerbate underlying myocardial dysfunction (magnitude: major) (AHA [Page 2016]). Consider chronic toxicity if conduction disorders (eg, bundle branch block, atrioventricular heart block) as well as biventricular hypertrophy are diagnosed. May also be associated with QT interval prolongation; ventricular arrhythmia and torsades de pointes have been reported (monitor QT-prolonging effects during therapy in at-risk patients or if used in combination with other medications that prolong the QT interval).
• Dermatologic effects: Skin reactions to hydroxychloroquine may occur; use with caution in patients on concomitant medications with a propensity to cause dermatitis.
• Hematologic effects: Bone marrow suppression (eg, agranulocytosis, anemia, aplastic anemia, leukopenia, thrombocytopenia) have been reported; periodically monitor CBC during prolonged therapy. Discontinue treatment if signs/symptoms of severe blood disorder not attributable to the underlying disease occur.
• Hypoglycemia: Severe hypoglycemia, including life-threatening loss of consciousness, has been reported in patients with and without concomitant use of antidiabetic agents. Advise patients of risk of hypoglycemia and associated signs/symptoms; discontinue use in patients who develop severe hypoglycemia.
• Neuromuscular effects: Proximal myopathy or neuromyopathy, leading to progressive weakness, proximal muscle atrophy, depressed tendon reflexes, and abnormal nerve conduction may occur, especially with long-term therapy. Curvilinear bodies and muscle fiber atrophy with vacuolar changes have been noted on muscle or nerve biopsy. Muscle strength (especially proximal muscles) and reflexes should be assessed periodically during long term therapy.
• Psychiatric effects: Suicidal behavior has been reported rarely.
• Retinal toxicity: Retinal toxicity, potentially causing irreversible retinopathy, is predominantly associated with high daily doses and a duration of >5 years of use of chloroquine or hydroxychloroquine in the treatment of rheumatic diseases. One study suggested a correlation of higher serum concentrations of hydroxychloroquine with ocular toxicity (Petri 2019). Other major risk factors include concurrent tamoxifen use, renal impairment, lower body weight, and the presence of macular disease. Daily hydroxychloroquine (base) doses >5 mg/kg actual body weight were associated with an ~10% risk of retinal toxicity within 10 years of treatment and an almost 40% risk after 20 years of therapy. Risk is most accurately assessed on the basis of duration of use relative to daily dose/body weight (Marmor [AAO 2016]; Melles 2014). Based on these risks, the American Academy of Ophthalmology (AAO) recommends not exceeding a daily hydroxychloroquine dosage of 5 mg/kg using actual body weight in most patients. Previous recommendations to use ideal body weight are no longer advised; very thin patients in particular were at increased risk for retinal toxicity using this practice. Current AAO guidelines do not specifically address dosing in obese patients. AAO also recommends baseline screening for retinal toxicity and annual screening beginning after 5 years of use (or sooner if major risk factors are present) (Marmor [AAO 2016]). If ocular toxicity is suspected, discontinue and monitor closely; retinal changes and visual disturbances may progress after discontinuation. A baseline ocular exam is recommended within the first year of initiating hydroxychloroquine treatment.
Sounds like what he said. He was there from 1968 - 1971, USMC.
Japan has shown it doesn't do anything. Up until a couple days ago they haven't closed anything except schools. There count of those being infected is worse then most countries. As of today 5,500 infected 119 dead.
Or that parachutes save lives!
It’s in the same family although Mefloquine was originally used early in Afghanistan ,but when I was there (2012-2013), it was switched to Doxycycline. I did some research and Mefloquine apparently had some serious side effects of hallucinations. I was given a bag of Doxy at my mobilization station in Winchester, VA.
Nu uh! I heard meeDUH brezinski say so so it must be true. LOL!
prolonged QT is associated with “a potentially fatal polymorphic ventricular tachycardia called torsades de pointes (TdP). Although usually self-limited, TdP may degenerate into ventricular fibrillation and cause sudden death”.
Moronic article. If you take it you are supposed to be under a doctor’s care and he/she is supposed to concur. One question you just might, maybe want to ask your doctor is what risks are involved.
I’m glad to hear that this doctor will practice what he preaches and will pass on this medication if he gets the virus. I’ll go with the other 67% of doctors who would take it themselves and give it to family members who got the virus.
Your life, for every one of them.
I'm a regular reader of MedScape, which is an online publication for many medical disease states, drugs, treatments, etc.
Occasionally, they'll slant to the left, but I've been reading user comments (many from doctors and other HCPs), and I've been somewhat heartened by what I've read. The vast majority of them are pro-hydroxychloroquine, and think the opposition is ridiculous.
What a sad state we're in when leaders are actively arguing against a potential treatment for this pandemic. This is the politicization of medicine, folks. Coming soon to a national healthcare scheme near you.
All of those side effects you listed are related to LONG TERM USE -— YEARS IN FACT.
For CoVid-19 treatment, we’re talking about something not longer than 2 weeks, in fact, 6 days on average.
Dr. Woolley-Brain is full of crap. The drug is very safe, especially in the short term use for CV - just five or six days. Who says so? The doctors who are successfully using it. A doctor with TDS is far more dangerous than this drug.
Yak... yak... yak... everything he’s said is a lie.
HCQ neutralizing the viroprotein you can find here
COVID-19: Attacks the 1-Beta Chain of Hemoglobin and Captures the Porphyrin to Inhibit Human Heme Metabolism
https://ravikollimd.com/resources/COVID/COVID-19__Attacks_the_1-Beta_Chain_of_Hemoglobin_and_Captures_the_Porphyrin_to_Inhibit_Human_Heme_Metabolism_v5.pdf
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