FDA: Don't use hydroxychloroquine outside of clinical setting

[Doheny]

Some here have mentioned getting the drug from TJ or other sources and talking it prophylactically or in case they have CV symptoms. The FDA warns against doing so outside of a clinical setting due to the possibility of serious health issues. From their website:

The FDA is aware of reports of serious heart rhythm problems in patients with COVID-19 treated with hydroxychloroquine or chloroquine, often in combination with azithromycin and other QT prolonging medicines. We are also aware of increased use of these medicines through outpatient prescriptions. Therefore, we would like to remind health care professionals and patients of the known risks associated with both hydroxychloroquine and chloroquine. We will continue to investigate risks associated with the use of hydroxychloroquine and chloroquine for COVID-19 and communicate publicly when we have more information.

Hydroxychloroquine and chloroquine have not been shown to be safe and effective for treating or preventing COVID-19.

https://www.fda.gov/drugs/drug-safety-and-availability/fda-cautions-against-use-hydroxychloroquine-or-chloroquine-covid-19-outside-hospital-setting-or

.

[Chewy65]

Focusing on just what is meant by adverse outcomes:

These adverse events were reported from the hospital and outpatient settings for treating or preventing COVID-19, and included QT interval prolongation, ventricular tachycardia and ventricular fibrillation, and in some cases death.

[CPRAFAN]

If chloroquine's so "dangerous" & even "poisonous," why has the CDC for years been ad

If chloroquine's so "dangerous" & even "poisonous," why has the CDC for years been advising this?:

FDA "Both adults and children should take one dose of chloroquine per week starting at least 1 week before traveling to the area where malaria transmission occurs"

https://www.cdc.gov/malaria/resources/pdf/fsp/drugs/chloroquine.pdf

I've been taking a 200mg HCQ pill 2x per week for 5 weeks per the Indian Ministry of Health Council advisory for doctors treating WuFlu patients for prevention of infection. Plus zinc daily. Noticed no bad or any effects.

Some here have mentioned getting the drug from TJ or other sources and talking it prophylactically or in case they have CV symptoms. The FDA warns against doing so outside of a clinical setting due to the possibility of serious health issues. From their website:

https://www.fda.gov/drugs/drug-safety-and-availability/fda-cautions-against-use-hydroxychloroquine-or-chloroquine-covid-19-outside-hospital-setting-or

.

[capo]

If chloroquine's so "dangerous" & even "poisonous," why has the CDC for years been advising this?:

FDA "Both adults and children should take one dose of chloroquine per week starting at least 1 week before traveling to the area where malaria transmission occurs"

https://www.cdc.gov/malaria/resources/pdf/fsp/drugs/chloroquine.pdf

I've been taking a 200mg HCQ pill 2x per week for 5 weeks per the Indian Ministry of Health Council advisory for doctors treating WuFlu patients for prevention of infection. Plus zinc daily. Noticed no bad or any effects.

It's a prescription medication for a reason and malaria prophylaxis is 1/7th the dosage of what most clinical trials are experimenting with to treat covid-19. That's a huge difference in dosing.

Self medicating without a doctor's say so is not smart at all, that's why drugs like these are only available by Rx . Neither the FDA or CDC have ever recommended what you're doing and neither would your physician.

[CPRAFAN]

HCQ is not a prescription drug in Mexico or most of the world

I use the Indian Ministry of Health Council guidelines for prevention of WuFlu for doctors treating WuFlu cases. To be on the safe side, I cut the dosage in half from 400mg per day 2x per week for 7 weeks to 200mg per day 2x per week. Plus zinc picolinate daily. No side effects. Mexico and many other countries with malaria sell this OTC. In the USA, the gatekeepers want $$$ to sign off on prescriptions that the pharmacist is qualified already to advise you about. Read that in Vietnam, the medics left bowls of anti-malaria pills out for the soldiers to dose themselves with - the hype over HCQ is amazing. To believe the media and Cuomo, you are safer dead than taking HCQ! lol If nothing else, I'm safe from malaria!

It's a prescription medication for a reason and malaria prophylaxis is 1/7th the dosage of what most clinical trials are experimenting with to treat covid-19. That's a huge difference in dosing.

Self medicating without a doctor's say so is not smart at all, that's why drugs like these are only available by Rx . Neither the FDA or CDC have ever recommended what you're doing and neither would your physician.

[Doheny]

Getting drugs from Mexico and following advise from India. What could go wrong?

[Chewy65]

Getting drugs from Mexico and following advise from India. What could go wrong?

I remember when India only admitted to 3 cases for weeks and some speculated that was because of the ubiquitous use of HCQ for malaria. Now it admits to over 26,000 cases and 800 deaths.

[SAN compnerd]

Some here have mentioned getting the drug from TJ or other sources and talking it prophylactically or in case they have CV symptoms. The FDA warns against doing so outside of a clinical setting due to the possibility of serious health issues. From their website:

https://www.fda.gov/drugs/drug-safety-and-availability/fda-cautions-against-use-hydroxychloroquine-or-chloroquine-covid-19-outside-hospital-setting-or

.

It's so weird that our (politically motivated) FDA would do this warning when Dr. Raoult just finished a 1000+ person study using HCQ+ZPAK and said zero evidence of cardiac issues.

Would our own corrupt FDA lie to the public about an issue that may kill people for political reasons?

Sure appears that way.

[seal20]

Oh yay this guy again, being fixated on crushing hopes and dreams in the name of saying "I told you Trump was wrong!!"

[Canucky]

Oh yay this guy again, being fixated on crushing hopes and dreams in the name of saying "I told you Trump was wrong!!"

Tide pods/Do it.

[CAL.BAR]

It's a prescription medication for a reason and malaria prophylaxis is 1/7th the dosage of what most clinical trials are experimenting with to treat covid-19. That's a huge difference in dosing.

Self medicating without a doctor's say so is not smart at all, that's why drugs like these are only available by Rx . Neither the FDA or CDC have ever recommended what you're doing and neither would your physician.

He is too busy listening to "dr trump".

[Doheny]

It's so weird that our (politically motivated) FDA would do this warning when Dr. Raoult just finished a 1000+ person study using HCQ+ZPAK and said zero evidence of cardiac issues.



Would our own corrupt FDA lie to the public about an issue that may kill people for political reasons?



Sure appears that way.

[buruli]

I set up a medical clinic in the Democratic Republic of Congo. I've been on hydroxychloroquine as an antimalarial in Africa for extended periods of time and I had no ill effects. However, antimalarial drugs are not a benign as Trump makes it seem. Clinical trials on the use of hydroxy have been dropped internationally due to adverse side effects and little evidence of efficacy. In fact one study showed more people died of COVID with hydroxychloroquine than without. We may love his 2A stance and other policies, but Trump needs to stop speculating and stop playing doctor.

[duenor]

It's so weird that our (politically motivated) FDA would do this warning when Dr. Raoult just finished a 1000+ person study using HCQ+ZPAK and said zero evidence of cardiac issues.

Would our own corrupt FDA lie to the public about an issue that may kill people for political reasons?

Sure appears that way.

Getting a drug to market is a very long process that involves years of study and research with the intent of making sure that all of its bad properties are well known (like, for example, killing 10% of the people treated with it). Even with such a laborious process, quite a few drugs have wound up doing more harm than good. Such is the food of class action lawsuits.

It is probably for this reason that the FDA remains reluctant to encourage the use of a drug with known dangerous effects based on the non peer reviewed research of a handful of doctors, some of which have rather dubious backgrounds. For a while it seemed like the FDA was going to go with Trump's messaging about it, but it seems that they have pulled back from doing so recently.

I certainly hope it works wonders. But based on how we've suddenly stopped hearing about it on Trump's daily briefings for a while now, I suspect it is not turning out to the "97%" cured drug that Raoult has been claiming.

[capo]

Logic fail.

The FDA works for Trump and we know what is feeling is (or maybe was) about the drug. Based on that one would assume that the FDA would be speaking in favor of it, rather than against it.

They’re choosing the scientific route rather than the political one.


Sent from free America

The FDA is a core component of our health care system and one which, while imperfect, has helped ensure we have some of the best and safest medicines available in the world.

Groups alternatively accuse the FDA of over or under regulation depending on the subject matter, oh then there's the real wingnuts who claim it's part of some evil cabal. There are also those who accuse it of being driven by politics rather than medical science, you have to evaluate the specific argument to decide whether it holds any water.

In this case the FDA authorized the emergency use of HCQ as soon as the first hints of clinical data indicated it might be useful in treating this disease, however they also urged caution that neither the general efficacy or proper dosing could be ascertained at the time. Due to the current state of clinical data and since people believe the drug is so safe they can take it without a physician's advice or prescription (a decision flies in the face of established medical facts and existing protocols in this country) the FDA has had to formally caution against its use outside of clinical settings.

This is in keeping with their express role as the nation's regulatory body on the safety and efficacy of medication in our health care system. Nothing about their decision making seems to be driven by politics, rather it has been driven by scientific evidence.


Edit: Worth noting the FDA has authorized the use of other drugs and therapies during this emerging pandemic to try treating CoVID-19, the only reason this one is getting so much attention is because it has been so radically politicized. Also worth noting the EUA is what allowed so much of the drug to become available for use in the first place by allowing access to the strategic national stockpile resources.