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Portrait of scientist with mask, glbades and gloves looking and examining hemp oil in a greenhouse. Alternative medicine herbal concept, cbd oil, pharmaceutical industry
Getty
The US Food and Drug Administration (FDA) wants the American public to know that cannabidiol (CBD), a non-intoxicant component of the sativa cannabis plant, may not be as safe and effective in their overall health plan and their well-being they are told. & nbsp;
The agency recently & nbsp;released an update for consumers on its website (FDA.gov), which addresses some of the many claims surrounding this widespread cannabinoid and attempts to dispel the concept of a safe miracle drug. & nbsp;
Although the FDA is currently collecting data from health professionals, cannabis industry representatives and patients, hoping to find out more about how CBD could be used to fight (or even cure ) the various attacks on civil society, questions on the science, safety and quality of products containing CBD, "& nbsp;the agency wrote. & nbsp;
As a result, the FDA wants to clarify some critical points about the CBD before more people join the public.
Research shows that CBD can cause liver damage
The FDA admits that it still does not really understand the potential risks (or benefits) to health badociated with CBD. But liver damage is one of the side effects he uncovered in his limited study.
In clinical trials on Epidiolex, a CBD-based epilepsy drug approved for the US market last year, researchers found that the drug was causing liver toxicity in some patients. & Nbsp;
"The FDA has identified some safety risks, including the risk of liver injury," & nbsp;the agency wrote. & nbsp;
It should be mentioned that Epidiolex is not pure CBD – nor the same concentration of CBD found in all hemp products that have found their way into the US market. The solution, available only on prescription, also contains "dehydrated alcohol, sesame seed oil, strawberry flavor and sucralose" & nbsp;according to the drug manufacturer GW Pharmaceuticals. However, the CBD used in this drug (CBD extract with 98% purified oil) is derived from the cannabis plant and from & nbsp;do not synthetically produced in a laboratory somewhere, as many have argued. This means that Epidiolex contains almost 100% of CBD derived from cannabis. It is hard to argue that these are less common ingredients that are causing the problem. & Nbsp;
Even apart from research on CBD and liver toxicity (using Epidiolex), it is possible to damage in large doses. & Nbsp;
Last month, Forbes introduced a & nbsp;study from the University of Arkansas for Medical Sciences who found & nbsp;high doses CBD caused liver damage in the mouse within 24 hours. Many animals died or were about to die in three or four days. Critics have argued that the dose used in this study was extreme, but that the highest dose used (615 mg / kg for 10 days) was "the allometric equivalent of the mouse … the dose". maximum recommended human maintenance. " Thus, while the dose of Epidiolex resulting in liver damage in mice was actually high, there are currently in the United States epileptic children in comparable amounts. This is the reason why, according to the & nbsp;prescription information for Epidiolex, doctors should monitor the liver enzymes of these patients. In clinical trials, 5 to 20% of patients had liver problems. As a result, some patients have been permanently removed from the study to prevent further damage. & Nbsp;
Even doctors in Colorado, where marijuana is legal for any purpose, monitor the liver enzymes of patients who decide to treat themselves with CBD or marijuana, according to a & nbsp;report of STAT News.
So the threat is real.
The & nbsp;most common side effects badociated with Epidiolex-based CBD include: "drowsiness, sedation and lethargy; high liver enzymes; decreased appetite; diarrhea; rash; fatigue, malaise and weakness; insomnia, sleep disorder and poor sleep; and infections. "
More serious side effects include: "suicidal thoughts, suicide attempts, feelings of agitation, new or worsening depression, aggression and panic attacks", & nbsp;the FDA wrote in a press release.
But what about my CBD products derived from hemp?
Although it is unlikely that all the scrubs and CBD oils consumed by Americans these days pose a risk to their liver (most of these products are & nbsp;weaker & nbsp;Epidiolex), the reality is that we simply do not know if it is possible to get hurt at high enough doses. After all, many others & nbsp;herbal supplements on the market today can cause liver damage, as well. These products, such as CBD, are not regulated by the FDA and this adverse reaction has been shown to occur in high doses. & Nbsp;
CBD probably does not cure cancer or any other disease
The FDA also wants Americans to understand that none of the CBD-based products sold in grocery stores, truck stops, health food stores or medical marijuana dispensaries will received his approval. Even the CBD derived from hemp sold at your local CVS or at Walgreens is not revered as a medicine.
Until now, Epidiolex is the only drug based on CBD in the United States to have obtained this privilege. He took his manufacturers (GW Pharmaceuticals) several years to prove to the FDA that his drug had the power to safely and effectively control the frequency of seizures.
Throughout this process, however, the FDA has determined that Epidiolex was only really useful in treating children with two rare forms of epilepsy: Lennox-Gastaut syndrome and the Dravet syndrome.
The drug has not been cleared for another health problem.
But even in the case of epilepsy, Epidiolex is not a sure thing. This medicine was only effective for & nbsp;32 percent patients. & nbsp; & nbsp;
Not really a miracle cure.
However, this does not prevent the cannabis industry from trying to convince the public that CBD can cure their pain, help relieve their anxiety, get them out of depression, give them a healthy heart and even protect them. cancer. The FDA fears that all unfounded claims about how the CBD can help relieve or even cure all kinds of health problems will give consumers false hope. & Nbsp; & nbsp; & nbsp;
"Misleading and false claims related to CBD products can cause consumers to delay obtaining important medical care, such as proper diagnosis, treatment and supportive care" & nbsp;the FDA wrote.
"The agency has & nbsp;warned Companies selling CBD products are expected to prevent, diagnose, treat or cure serious diseases such as cancer, Alzheimer's disease, psychiatric disorders and diabetes. "
We must emphasize that the FDA, although designed to protect public safety with respect to food and drugs, is not exactly foolproof. & Nbsp;
The agency has approved several prescription drugs over the years, to end up recalling them years (sometimes decades) later. Some opioid badgesics, ADHD medications, cholesterol medications and antihistamines have finally been & nbsp;pulled from the shelves because of cases where patients have experienced serious or life-threatening side effects due to these medications. & nbsp;
A & nbsp;study published in 2017 revealed that nearly one-third of all FDA-approved drugs between 2001 and 2010 were subsequently reported as a security threat.
"The key message of all new drugs and technologies is that there is a lifelong learning process that will last throughout the life of the drug" & nbsp;Lead author, Dr. Nicholas S. Downing, told CNN.
Medicines are completely removed from the market "only when the risks outweigh the benefits" & nbsp;according to the FDA. Thus, what is considered safe for today's public consumption could end up ravaging it in the future. This may be why the latest Gallup poll shows that only the & nbsp;44 percent the public thinks the agency is doing a great job. Many Americans simply do not trust the FDA to provide them with the truth about drugs. & Nbsp;
On the other hand, we know very little about the CBD at this stage. More research is needed before we can really weigh the pros and cons of this cannabinoid and evaluate its medicinal function.
The best advice to give a person who is considering the use of CBD to help him get out of trenches of a serious medical condition is to consult his family doctor, his oncologist or other specialist to make sure that they do not put their lives in jeopardy. .
Simply do not blindly accept the hype of the CBD. & Nbsp;
Although, to our knowledge, cannabis derivatives are safer than other drugs, we still have a lot to learn about this cannabinoid before we can say, without a shadow of a doubt, that its safety and efficacy for conditions ranging from pain management to cancer treatment has been properly badessed. & nbsp; & nbsp;
Be careful there, guys!
">
Portrait of scientist with mask, glbades and gloves looking and examining hemp oil in a greenhouse. Alternative medicine herbal concept, cbd oil, pharmaceutical industry
Getty
The US Food and Drug Administration (FDA) wants the American public to know that cannabidiol (CBD), a non-intoxicant component of the sativa cannabis plant, may not be as safe and effective in their overall health plan and their well-being they are told.
The agency recently released a consumer-friendly update on its website (FDA.gov), which resolves some of the many claims surrounding this widespread cannabinoid and tries to dispel the idea that it's going to happen. Is a miracle drug without risk.
Although the FDA is currently collecting data from health professionals, cannabis industry representatives and patients, hoping to find out more about how CBD could be used to fight (or even cure ) the various attacks on civil society, questions on the science, safety and quality of products containing CBD, "the agency wrote.
As a result, the FDA wants to clarify some critical points about the CBD before more people join the public.
Research shows that CBD can cause liver damage
The FDA admits that it still does not really understand the potential risks (or benefits) to health badociated with CBD. But liver damage is one of the side effects he uncovered in his limited study.
In clinical trials on Epidiolex, a CBD-based epilepsy drug approved for the US market last year, researchers found that the drug was causing liver toxicity in some patients.
"The FDA has identified some safety risks, including the risk of liver damage," the agency wrote.
It should be mentioned that Epidiolex is not pure CBD – nor the same concentration of CBD found in all hemp products that have found their way into the US market. The solution, available only on prescription, also contains "dehydrated alcohol, sesame seed oil, strawberry aroma and sucralose," according to drug manufacturer GW Pharmaceuticals . However, the CBD used in this drug (CBD extract with 98% purified oil) is derived from the cannabis plant and do not synthetically produced in a laboratory somewhere, as many have argued. This means that Epidiolex contains almost 100% of CBD derived from cannabis. It is difficult to say that it is less common ingredients that are the cause.
Even apart from research on CBD and liver toxicity (using Epidiolex), it is possible to damage in large doses.
Last month, Forbes presented a study from the University of Arkansas on the medical sciences that revealed high doses CBD caused liver damage in the mouse within 24 hours. Many animals died or were about to die in three or four days. Critics have argued that the dose used in this study was extreme, but that the highest dose used (615 mg / kg for 10 days) was "the allometric equivalent of the mouse … the dose". maximum recommended human maintenance. " Thus, while the dose of Epidiolex resulting in liver damage in mice was actually high, there are currently in the United States epileptic children in comparable amounts. This is the reason why, according to Epidiolex's prescribing information, doctors must monitor the liver enzymes of these patients. In clinical trials, 5 to 20% of patients had liver problems. As a result, some patients have been permanently removed from the study to prevent further damage.
Even doctors in Colorado, where marijuana is legal for any purpose, are monitoring the liver enzymes of patients who decide to treat themselves with CBD or marijuana, according to a report by STAT News.
So the threat is real.
The most common side effects badociated with CBD-based Epidiolex are: "drowsiness, sedation and lethargy; high liver enzymes; decreased appetite; diarrhea; rash; fatigue, malaise and weakness; insomnia, sleep disorder and poor sleep; and infections. "
More serious side effects include "suicide thoughts, suicide attempts, feelings of agitation, a new or worsening depression, attacks of aggression and panic," wrote the FDA in a statement. Press release.
But what about my CBD products derived from hemp?
While it is unlikely that all the scrubs and oils containing CBD that Americans consume these days will present risks to their liver (most of these products are weaker Epidiolex), the reality is that we simply do not know if it is possible to get hurt at high enough doses. After all, many other herbal supplements on the market can also cause liver damage. These products, such as CBD, are not regulated by the FDA and it has been proven that this side effect occurs at high doses.
CBD probably does not cure cancer or any other disease
The FDA also wants Americans to understand that none of the CBD-based products sold in grocery stores, truck stops, health food stores or medical marijuana dispensaries will received his approval. Even the CBD derived from hemp sold at your local CVS or at Walgreens is not revered as a medicine.
Until now, Epidiolex is the only drug based on CBD in the United States to have obtained this privilege. It took several years for its manufacturers (GW Pharmaceuticals) to prove to the FDA that its drug had the power to safely and effectively control the frequency of seizures.
Throughout this process, however, the FDA has determined that Epidiolex was only really useful in treating children with two rare forms of epilepsy: Lennox-Gastaut syndrome and the Dravet syndrome.
The drug has not been cleared for another health problem.
But even in the case of epilepsy, Epidiolex is not a sure thing. This drug was only effective in 32% of patients.
Not really a miracle cure.
However, this does not prevent the cannabis industry from trying to convince the public that CBD can cure their pain, help relieve their anxiety, get them out of depression, give them a healthy heart and even protect them. cancer. The FDA is concerned that all unfounded claims about how the CBD can help relieve or even cure all kinds of health problems will give consumers false hope.
"Misleading and false claims badociated with CBD-based products can cause consumers to delay obtaining important medical care, such as proper diagnosis, treatment and supportive care," wrote the author. FDA.
"The agency has warned companies selling CBD-based products meant to prevent, diagnose, treat or cure serious diseases such as cancer, Alzheimer's, psychiatric disorders and diabetes."
It should be noted that the FDA, while designed to protect public safety in food and medicine, is not exactly foolproof.
The agency has approved several prescription drugs over the years, to end up recalling them years (sometimes decades) later. Some opioid badgesics, ADHD medications, cholesterol medications and antihistamines have finally been removed from the shelves due to cases where patients have experienced serious or life-threatening adverse reactions as a result of these medications.
A study published in 2017 found that close to one-third of all FDA-approved drugs between 2001 and 2010 were later reported as a security threat.
"The key message of all new drugs and technologies is that there is a lifelong learning process that will last the life of the drug," said CNN's lead author, Dr. Nicholas. S. Downing.
Medicines are completely removed from the market "only when the risks outweigh the benefits," according to the FDA. Thus, what is considered safe for today's public consumption could end up ravaging it in the future. It's perhaps for this reason that the latest Gallup poll shows that only 44% of the population feels that the agency is doing excellent work. Many Americans simply do not trust the FDA to provide them with the truth about drugs.
On the other hand, we know very little about the CBD at this stage. More research is needed before we can really weigh the pros and cons of this cannabinoid and evaluate its medicinal function.
The best advice to give a person who is considering the use of CBD to help him get out of trenches of a serious medical condition is to consult his family doctor, his oncologist or other specialist to make sure that they do not put their lives in jeopardy. .
Just do not blindly buy the hype from the CBD.
Although, to our knowledge, cannabis derivatives are safer than other drugs, we still have a lot to learn about this cannabinoid before we can say, without a shadow of a doubt, that its safety and efficacy for conditions ranging from pain management to cancer treatment has been properly badessed.
Be careful there, guys!
