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FDA finally put black box warning on all benzodiazepines


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Dear All - havne't been on this site in a long time but wanted to share the below - since i work in the pharmaceutical industry and manage FDA interactions - i receive these alerts - to receive a black box warning is a very significant consequence - sadly - not sure it will deter doctors from continuing to give these meds out like candy - but it means our voices are starting to be heard.

 

U.S. Food and Drug Administration <usfda@public.govdelivery.com>

Wed 9/23/2020 4:01 PM

 

 



Boxed Warning Updated to Improve Safe Use

MedWatch Header Pharmacy

MedWatch - The FDA Safety Information and Adverse Event Reporting Program

 

TOPIC: Benzodiazepine Drug Class: Drug Safety Communication - Boxed Warning Updated to Improve Safe Use

 

AUDIENCE: Patient, Health Professional, Pharmacy

 

ISSUE: The FDA is requiring the Boxed Warning, FDA’s most prominent warning, be updated by adding other information to the prescribing information for all benzodiazepine medicines. This information will describe the risks of abuse, misuse, addiction, physical dependence, and withdrawal reactions consistently across all the medicines in the class. The FDA is also requiring updates to the existing patient Medication Guides to help educate patients and caregivers about these risks.

 

Other changes are also being required to several sections of the prescribing information, including to the Warnings and Precautions, Drug Abuse and Dependence, and Patient Counseling Information sections.

 

BACKGROUND: Benzodiazepines are a class of medicines approved to treat generalized anxiety disorder, insomnia, seizures, social phobia, and panic disorder.

 

RECOMMENDATION:

 

Health Care Professionals

 

Consider the patient’s condition and the other medicines being taken, and assess the risk of abuse, misuse, and addiction.

Limit the dosage and duration of each medicine to the minimum needed to achieve the desired clinical effect when prescribing benzodiazepines, alone or in combination with other medicines.

Use a gradual taper to reduce the dosage or to discontinue benzodiazepines to reduce the risk of acute withdrawal reactions.

Take precautions when benzodiazepines are used in combination with opioid addiction medications.

Patients, Parents, and Caregivers

 

Always tell your health care professionals about all the prescription and over-the-counter (OTC) medicines you are taking or any other substances you are using, including alcohol.

Take benzodiazepines and all medicines exactly as prescribed by your health care professional

Discuss a plan for slowly decreasing the dose and frequency of your benzodiazepine(s) with your health care professional.

Contact your health care professional if you experience withdrawal symptoms or your medical condition worsens.

Go to an emergency room or call 911 if you have trouble breathing or other serious side effects such as seizures.

Health professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

 

Complete and submit the report online.

Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on form, or submit by fax to 1-800-FDA-0178.

 

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https://www.nytimes.com/2020/09/23/health/benzodiazepines-fda-warning.html?utm_content=bufferec27f&utm_medium=social&utm_source=facebook.com&utm_campaign=buffer&fbclid=IwAR12ux7fA5tFpP9DQdbUl98GfP4vFNn6iD8X_34V2uGKU1l2nhhkj7HQP2c

 

what this part should have really said "In a press statement, Dr. Stephen Hahn, the F.D.A. commissioner, said he was concerned about widespread misuse of the drugs," translation: In a press statement, Dr. Stephen Hahn, the F.D.A. commissioner, said he was concerned about widespread over-prescribing by un-knowledgeable Doctors, of this class of meds, onto unsuspecting patients, there, fixed it!!!!!

 

and Why can’t anyone seem to get the info right and correct the misleading language used when talking about the use, prescribing and damage these drugs cause. We’re always painted as addicts who misuse / abuse the drugs when most of us take them as prescribed without warning. And when the withdrawal is actually acknowledged by someone it’s played down!

 

"It's definitely a step in the right direction - updated the Black Box Warning. However, doctors rarely informed patients about the original Box Warning before this -- so it will only be effective if the doctors pass this information onto their patients. I also did not like the statement "benzos are commonly abused and misused..." when in actuality, in most cases of harm, they were taken 'as prescribed!'

 

 

 

 

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This new warning addresses the suicidal and homicidal ideation that these meds cause, something I've been preaching on this forum for the entire duration of my withdrawal, which I'm still not 100% recovered from after 30 months off cold turkey. It's clearly going to take me a year or more to recover fully. Why aren't people who were damaged by these drugs being offered reparations in some form or fashion. I've been gaslit on this forum the entire time too and now the FDA is outright saying that these meds cause these symptoms. Absolute torture. I'm convinced I've had the absolute worse withdrawal that only like 5% of the people on this forum could even understand.
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I hope this helps to save some people; even if it’s a few lives. The less people on these drugs the better. Hopefully some Drs will be influenced by this.
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Boombox boy,  I know how you feel. I actually think I'm in the 1%, because nobody should take 8 mg a day of Klonopin and 40 mg of Valium for 20 years straight and then go cold turkey multiple times. And that's another problem, doctors like to pull people off cold turkey. They think tapering for a couple days at the hospital makes it better or something even though it doesn't. FDA doesn't have any rules against that.

 

And the FDA thinks that it only takes months, and not years. And they don't have any idea of what people go through, they just think you'll get anxiety or something.

 

And these pharmaceutical companies are never going to reimburse anybody because we took them longer than suggested. They suggest not taking them any more than four weeks.

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This is a step in the right direction. I believe I will see the day in my lifetime that benzos are no longer used except for status epilepticus as a one time dose. I think SSRI's will be used considerably less as well.

 

I believe this because almost everyone takes these drugs or has taken them at some point in their life. The people I know personally who've taken them, including myself, never needed them in the first place. What they really needed to do was make better life decisions, exercise, get divorced, end a toxic relationship or get a new career. People who are doctors, and nurses, lobbyists and politicians etc take these drugs too. Enough people in a position to damn do something about it once they are pissed that they are fighting through withdrawal themselves. This will start major action towards the end of benzodiazepines.

 

The problem is that the "oops I'm in trouble with tolerance" rears it's ugly head in a matter of months or years. Not always I know, but most of the time. It's because the symptoms start out subtle & slow. So once we have a nation with a high rate of patients who've been on them a number of years running into issues, the numbers themselves will push it to law. Yes, even beating the money hungry drug manufacturers. It will be the sheer number of those affected including those in high positions that will suffer too, and doctors themselves already harmed and going through withdrawal with these drugs.

 

This is not a perfect example of what i'm saying, but check out the history of the medication Thalidomide. Babies born with deformed arms and legs. There are probably people on this forum that are old enough to remember Thalidomide at least from the news when they were younger.

 

Also, I worked for two doctors in my life. There were no "kick backs" for writing benzo scripts. Benzos are such an old drug. Doctors who recieve kick backs for drugs are the ones paid to travel and do talks and presentations for the drug companies. In a typical practice, when drug reps come in, the "kick back" is a lunch for the staff. There is a law prohibiting big money kick backs to doctors. You'd have to personally know a doctor and a drug rep well to get the truth about drug kick backs for doctors. When people spout off about drug kick backs it's usually something the news sensationalized. It's not common for doctors in a typical practice to get rich off of writing prescriptions.

 

I believe most of the doctors just don't want to be bothered with a patient that starts to run into issues with benzos, nor do they want to be liable if a patient dies from withdrawal. They don't believe it's worth their time to teach that a proper taper is safer. When the truth is that the majority survive and it is very much worth their time to properly inform the patient. If they do anything (which they usually don't do a damn thing) they push them off to drug rehab so they are not held accountable themself.

 

The prescribing info for benzos says no more than 3-4 weeks. I think it is this "golden nugget" that will get the physicians who irresponsibly prescribe them in the end. If a doctor is prescribing them longer than this, they will start to be held accountable. They are the ones who are to blame. When is the last time you've seen a commercial for Xanax, Ativan, Klonipin, or Valium? I've never seen one in my life! There are ads from the 60's though...before I was born. Big pharma needs to admit their drug is poison but that's probably not going to happen. It's on the prescribing doctor. They need to quit turning their heads away from those who suffer. It'll happen because too many people will be pissed.

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I also worked in the pharmaceutical industry (for 30 years) and managed the FDA interactions for Rx drugs.  I'm only 2 months into my journey but as I lie in bed suffering I could not fathom that these drugs were not properly labelled to warn for these withdrawal effects.  I just quickly looked at the fda website on this notice (https://www.fda.gov/drugs/drug-safety-and-availability/fda-requiring-boxed-warning-updated-improve-safe-use-benzodiazepine-drug-class) and am VERY DISAPPOINTED to see that the Z drugs are not listed! Although technically not benzos, I know FDA must be aware of the similar concerns with misuse, etc.  The lobby for these Z drugs must be very strong...When I feel better I need to do some research on whether they too are being reviewed for such a labelling update.
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On the positive side, they're actually using the phrase "physical dependence", and not just "addiction", "abuse" and "misuse". That's an important distinction to make, and it's not always acknowledged.

 

Physical dependence can occur when benzodiazepines are taken steadily for several days to weeks, even as prescribed.

 

https://www.fda.gov/drugs/drug-safety-and-availability/fda-requiring-boxed-warning-updated-improve-safe-use-benzodiazepine-drug-class

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I agree Ajusta, witch hunts against drugs end up backfiring and harming people already on drugs. Governments ought to put in place moratorium on new prescriptions while providing maintanance for old prescriptions. Instead, what happens is governments drown doctors in meaningless red tape and doctors just stop maintaining old prescriptions.
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Ah, I found it.  Here's a quote from it. " Physical dependence can occur when benzodiazepines are taken steadily for several days to weeks, even as prescribed. Stopping them abruptly or reducing the dosage too quickly can result in withdrawal reactions, including seizures, which can be life-threatening."

 

I'm glad they have included that you can develop dependence, even if you take them as prescribed, which most people on this forum already know.  Too bad they didn't include how lengthy withdrawal can be, but at least they acknowledge it's existence.  This is a step in the right direction.

 

Here's the link to the fda update:  https://www.fda.gov/drugs/drug-safety-and-availability/fda-requiring-boxed-warning-updated-improve-safe-use-benzodiazepine-drug-class

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And here's a quote from the section called "What should health care professionals do?"

 

 

 

When deciding whether the benefits of prescribing a benzodiazepine outweigh the risks, health care professionals should consider the patient’s condition and the other medicines being taken, and assess the risk of abuse, misuse, and addiction. Particular caution should be taken when prescribing benzodiazepines with opioids and other medicines that depress the central nervous system (CNS), which has resulted in serious side effects, including severe respiratory depression and death. Advise patients to seek immediate medical attention if they experience symptoms, such as difficulty breathing.

 

Limit the dosage and duration of each medicine to the minimum needed to achieve the desired clinical effect when prescribing benzodiazepines, alone or in combination with other medicines. Throughout therapy, monitor the patient for signs and symptoms of abuse, misuse, or addiction. If a substance use disorder is suspected, evaluate the patient and institute, or refer them for, early substance abuse treatment, as appropriate.

 

To reduce the risk of acute withdrawal reactions, use a gradual taper to reduce the dosage or to discontinue benzodiazepines. No standard benzodiazepine tapering schedule is suitable for all patients; therefore, create a patient-specific plan to gradually reduce the dosage, and ensure ongoing monitoring and support as needed to avoid serious withdrawal symptoms or worsening of the patient’s medical condition.

 

Take precautions when benzodiazepines are used in combination with opioid addiction medications. Careful medication management by health care professionals can reduce the increased risk of serious side effects.

 

 

https://www.fda.gov/drugs/drug-safety-and-availability/fda-requiring-boxed-warning-updated-improve-safe-use-benzodiazepine-drug-class

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The next step is to regulate how these drugs are prescribed, amts, duration, and time of drug tapering for the already using. And of course pharmacies should be on board with this too. I need to be handled more like how the opiod epidemic was.

 

I personally think they should only be used when a person has a seizure or for a brief medical procedure - never for psychiatric purposes. Just my opinion.

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AND require EVERY doctor to get a copy of the Ashton manual. Make a requirement in continuing education to have a course on tapering benzodiazepines and Z drugs.
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Ah, I found it.  Here's a quote from it. " Physical dependence can occur when benzodiazepines are taken steadily for several days to weeks, even as prescribed. Stopping them abruptly or reducing the dosage too quickly can result in withdrawal reactions, including seizures, which can be life-threatening."

 

I'm glad they have included that you can develop dependence, even if you take them as prescribed, which most people on this forum already know.  Too bad they didn't include how lengthy withdrawal can be, but at least they acknowledge it's existence.  This is a step in the right direction.

 

Here's the link to the fda update:  https://www.fda.gov/drugs/drug-safety-and-availability/fda-requiring-boxed-warning-updated-improve-safe-use-benzodiazepine-drug-class

 

Ah, I found it.  Here's a quote from it. " Physical dependence can occur when benzodiazepines are taken steadily for several days to weeks, even as prescribed. Stopping them abruptly or reducing the dosage too quickly can result in withdrawal reactions, including seizures, which can be life-threatening."

 

I'm glad they have included that you can develop dependence, even if you take them as prescribed, which most people on this forum already know.  Too bad they didn't include how lengthy withdrawal can be, but at least they acknowledge it's existence.  This is a step in the right direction.

 

Here's the link to the fda update:  https://www.fda.gov/drugs/drug-safety-and-availability/fda-requiring-boxed-warning-updated-improve-safe-use-benzodiazepine-drug-class

 

Greencup

 

This is so important! Thank you for posting!

 

They do acknowledge how lengthy withdrawal can be within this same link to the FDA prescribing info.

 

I know it's not what we want it to say. I know it talks about misuse & abuse, BUT like you pointed out it mentions that "physical dependence can occur in several dsys to weeks - as prescribed".

This is very powerful. This sentence right here, in the FDA prescribing info is VERY powerful.

 

Use it as a "sword & shield" for those doubting doctors, or whomever doubts. Print it out. Carry it around. It's a "sword & shield."

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You are right Miss Fortitude.  They actually do mention that withdrawal "may last months".  I guess I don't feel that describes it well enough, but it technically is correct.    But I looked over the other parts again and the description of withdrawal, is actually pretty good.  I mean, it doesn't have everything, but it does include a lot of it biggies.  In case anyone is interested, it's under, "Additional Information for Patients" in this link:  https://www.fda.gov/drugs/drug-safety-and-availability/fda-requiring-boxed-warning-updated-improve-safe-use-benzodiazepine-drug-class 
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This really is good news.

 

"In 2019, an estimated 92 million benzodiazepine prescriptions were dispensed from U.S. outpatient retail and mail-order pharmacies..."

 

Is that 92 million patients or 92 million refills?? (Under "Facts about benzodiazepenes")

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I don't like that it recommends doctors put their patient on a "gradual" taper without saying anything about what that means. It allows room for equivocation and vulnerable patients may not pick up on it. It should make it a little easier to coach a naive newbie to pull their doctor into line, though. We know that some doctors will propose a withdrawal plan that is not gradual by any measure.
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This really is good news.

 

"In 2019, an estimated 92 million benzodiazepine prescriptions were dispensed from U.S. outpatient retail and mail-order pharmacies..."

 

Is that 92 million patients or 92 million refills?? (Under "Facts about benzodiazepenes")

 

I interpret this statement to mean 92 MM separately dispensed prescriptions which are made up of both initial prescriptions and refills.  So not 92 MM people per se, but certainly widespread use in just one year!

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