Doctors need freedom to choose off-label drugs

[Peter1469]

In my state and for COVID-19, those and other therapies can be claimed as "compassionate use" because there is no specific treatment approved yet... There is a specific procedure for that...
Where are you aware of "off label" use? You state "some doctors" who are they?

20% of all prescriptions in the US are off label.

I have posted threads and posts with links to doctors currently using this drug combo off label.

[texan]

A lot of the hoarding is by doctors and other medical professionals who are able to write prescriptions for themselves.

I get the problem "may" be real. One example hardly proves it. But that is quite a jump to blame it on Trump. Jesus you are a piece of work. Really another word comes to mind.

Really solid post ends with Because Trump F'd up! Like we couldn't see that coming? Who are you Joe Scarborough?

[Padme]

20% of all prescriptions in the US are off label.
I have posted threads and posts with links to doctors currently using this drug combo off label.

Yeah, I agree, there is off label use for many things, but Chloroquine, and Hydroxychloroquine (Within a bunch of others) need to be handle very carefully, by professionals, and under serious considerations.

Democrats are having a blast with President Trump's words


Arizona man dies after self-medicating to prevent COVID-19 coronavirus

A couple in their 60s took chloroquine phosphate after hearing about it on TV and became violently ill within 20 minutes. The man died at the hospital.

Published: 1:41 PM MST March 23, 2020
Updated: 5:22 AM MST March 24, 2020

PHOENIX — Health experts at Banner Health issued a warning Monday after an Arizona man died and a woman was critically ill after ingesting a chemical.
The chemical, chloroquine phosphate, can be used to treat malaria, Banner Health experts said. It can also be used to clean fish tanks, according to Banner Health.

https://www.12news.com/article/news/health/coronavirus/man-dies-after-self-medication-to-prevent-covid-19/75-3c832083-c740-41c4-9360-286391e1d095

[Peter1469]

Yeah, I agree, there is off label use for many things, but Chloroquine, and Hydroxychloroquine (Within a bunch of others) need to be handle very carefully, by professionals, and under serious considerations.

Democrats are having a blast with President Trump's words


Arizona man dies after self-medicating to prevent COVID-19 coronavirus

A couple in their 60s took chloroquine phosphate after hearing about it on TV and became violently ill within 20 minutes. The man died at the hospital.

Published: 1:41 PM MST March 23, 2020
Updated: 5:22 AM MST March 24, 2020

PHOENIX — Health experts at Banner Health issued a warning Monday after an Arizona man died and a woman was critically ill after ingesting a chemical.
The chemical, chloroquine phosphate, can be used to treat malaria, Banner Health experts said. It can also be used to clean fish tanks, according to Banner Health.

https://www.12news.com/article/news/health/coronavirus/man-dies-after-self-medication-to-prevent-covid-19/75-3c832083-c740-41c4-9360-286391e1d095

Chloroquine phosphate for fish tanks is not a medicine. This couple was stupid.

[Padme]

Chloroquine phosphate for fish tanks is not a medicine. This couple was stupid.

Yes, very unfortunate ... and you already know who is going to be blamed for it, correct?

[Peter1469]

Yes, very unfortunate ... and you already know who is going to be blamed for it, correct?

By retarded people? Of course. Trump.

And the "media" will cover for those retarded people. Very few sources are even bothering to report on the difference between the drug Trump touted with the fish bowl cleaner. That is journalistic malpractice.

[Adelaide]

No; there are regulations for a reason. For example, using a migraine medication might be appropriate in an adult male with a history of migraines, but be off-label for a pregnant or breastfeeding woman with migraines. Why? Because it has never been tested specifically in that population to ensure that there would be no short- or long-term consequences or contraindications. It is also possible that the pregnant woman is experiencing something related to pregnany, like hypertension or preeclampsia. Likewise, it could be off-label in teens or children with the same reasoning of unknown consequences/contraindications.

There are a lot of problems with the FDA and with how medications are approved, but the solution is not to rip down the barriers that exist to protect people. Perhaps the FDA should find a way to make it less expensive for companies to run the clinical trials necessary to prove a medication is safe for alternative uses, for example.

[Peter1469]

No; there are regulations for a reason. For example, using a migraine medication might be appropriate in an adult male with a history of migraines, but be off-label for a pregnant or breastfeeding woman with migraines. Why? Because it has never been tested specifically in that population to ensure that there would be no short- or long-term consequences or contraindications. It is also possible that the pregnant woman is experiencing something related to pregnany, like hypertension or preeclampsia. Likewise, it could be off-label in teens or children with the same reasoning of unknown consequences/contraindications.

There are a lot of problems with the FDA and with how medications are approved, but the solution is not to rip down the barriers that exist to protect people. Perhaps the FDA should find a way to make it less expensive for companies to run the clinical trials necessary to prove a medication is safe for alternative uses, for example.

Yet 20% of all prescriptions are off label. Gabapentin for example for epilepsy, yet it is one of the most prescribed meds in the US. The vast majority of which is off label.

[Padme]

Yet 20% of all prescriptions are off label. Gabapentin for example for epilepsy, yet it is one of the most prescribed meds in the US. The vast majority of which is off label.

Gosh, and you mentioned just one! I know, clinicians are reading reliable sources...

Gabapentin for Off-Label Use: Evidence-Based or Cause for Concern?

Published online 2018 Sep 23

Abstract

Gabapentin is widely used in the United States for a number of off-label indications, often as an alternative to opioid therapy. Increasing evidence has emerged suggesting that gabapentin may not be as benign as once thought and may be associated with substance abuse in concert with opioids. With concerns for safety mounting, it is prudent to examine the efficacy of gabapentin across its many uses to understand the risk-benefit balance. Reviews on off-label indications such as migraine, fibromyalgia, mental illness, and substance dependence have found modest to no effect on relevant clinical outcomes. This high-quality evidence has often been overshadowed by uncontrolled studies and limited case reports. Furthermore, the involvement of gabapentin in questionable marketing schemes further calls its use into question. Overall, clinicians should exercise rigorous appraisal of the available evidence for a given indication, and researchers should conduct larger, higher-quality studies to better assess the efficacy of gabapentin for many of its off-label uses.

Conclusions

Gabapentin has several potential therapeutic uses and may represent a safer option versus alternative agents in some of these indications, so the intent of this analysis is not to condemn its use. However, it is prudent to recognize that gabapentin has seen high rates of off-label use and increased prescribing in recent years, which fails to align with current evidence regarding efficacy. Indeed, most of the evidence for off-label use is limited to a few small, low-quality studies, often with data only weakly supporting use. Higher quality evidence, which indicates gabapentin nonefficacy, is often lost in the shuffle. Given the increasing reports of abuse and evidence of potential harms associated with gabapentin use, it is important to realize the potential risks associated with this medication and weigh these risks against this lack of reliable evidence purporting its efficacy for many of its off-label uses. Thus, we urge clinicians to apply a more stringent appraisal of the available evidence for a given indication when prescribing gabapentin off-label and call for larger, higher-quality studies to be conducted to better assess the efficacy of gabapentin for many of its off-label uses.

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6153543/

[Peter1469]

This does not counter the fact that gabapentin is used off label far more than it is used for what it was approved for.

The dangers of misuse of gsbapentin is a very recent discovery- last couple of years. Up until then it was considered very safe.

Off-Label Drug Use: What You Need to Know

The next time your doctor writes you a prescription, consider this: The medication may not be approved for your specific condition or age group.But you probably shouldn't call the medical board. The practice, called "off-label" prescribing, is entirely legal and very common. More than one in five outpatient prescriptions written in the U.S. are for off-label therapies.


"Off-label" means the medication is being used in a manner not specified in the FDA's approved packaging label, or insert. Every prescription drug marketed in the U.S. carries an individual, FDA-approved label. This label is a written report that provides detailed instructions regarding the approved uses and doses, which are based on the results of clinical studies that the drug maker submitted to the FDA.


“Many people may be surprised to know that the FDA regulates drug approval, not drug prescribing, and ... doctors are free to prescribe a drug for any [reason they think is medically appropriate],” says G. Caleb Alexander, MD, MS, a medical ethics advocate and assistant professor of medicine at the University of Chicago Medical Center. "Off-label use is so common, that virtually every drug is used off-label in some circumstances.

Despite the prominence of off-label drug use, experts say few patients are aware that they are receiving a drug off-label. And doctors are not required to tell a patient that a drug is being used off-label.
Atlanta suburbanite Michelle Murphy was stunned to learn nadolol, the beta-blocker medicine she had been taking every day for several years to prevent migraines, was not actually approved for that use.
"It’s almost like we are test subjects, being reassured that everything will be fine because it worked to help people in studies that were taking it, but not exactly for what we are taking it for," Murphy says.
Benefits of Off-Label Drug Use


Off-label prescribing isn't necessarily bad. It can be beneficial, especially when patients have exhausted all other approved options, as may be the case with rare diseases or cancer.


According to the American Cancer Society, cancer treatment often involves using certain chemotherapy drugs off-label, because a chemotherapy drug approved for one type of cancer may actually target many different types of tumors. Off-label use of a drug or combination of drugs often represents the standard of care.

More at the link.

Gosh, and you mentioned just one! I know, clinicians are reading reliable sources...

Gabapentin for Off-Label Use: Evidence-Based or Cause for Concern?

Published online 2018 Sep 23

Abstract

Gabapentin is widely used in the United States for a number of off-label indications, often as an alternative to opioid therapy. Increasing evidence has emerged suggesting that gabapentin may not be as benign as once thought and may be associated with substance abuse in concert with opioids. With concerns for safety mounting, it is prudent to examine the efficacy of gabapentin across its many uses to understand the risk-benefit balance. Reviews on off-label indications such as migraine, fibromyalgia, mental illness, and substance dependence have found modest to no effect on relevant clinical outcomes. This high-quality evidence has often been overshadowed by uncontrolled studies and limited case reports. Furthermore, the involvement of gabapentin in questionable marketing schemes further calls its use into question. Overall, clinicians should exercise rigorous appraisal of the available evidence for a given indication, and researchers should conduct larger, higher-quality studies to better assess the efficacy of gabapentin for many of its off-label uses.

Conclusions

Gabapentin has several potential therapeutic uses and may represent a safer option versus alternative agents in some of these indications, so the intent of this analysis is not to condemn its use. However, it is prudent to recognize that gabapentin has seen high rates of off-label use and increased prescribing in recent years, which fails to align with current evidence regarding efficacy. Indeed, most of the evidence for off-label use is limited to a few small, low-quality studies, often with data only weakly supporting use. Higher quality evidence, which indicates gabapentin nonefficacy, is often lost in the shuffle. Given the increasing reports of abuse and evidence of potential harms associated with gabapentin use, it is important to realize the potential risks associated with this medication and weigh these risks against this lack of reliable evidence purporting its efficacy for many of its off-label uses. Thus, we urge clinicians to apply a more stringent appraisal of the available evidence for a given indication when prescribing gabapentin off-label and call for larger, higher-quality studies to be conducted to better assess the efficacy of gabapentin for many of its off-label uses.

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6153543/