Author Topic: FDA finally put black box warning on all benzodiazepines  (Read 2411 times)

[Buddie]

Re: FDA finally put black box warning on all benzodiazepines
« Reply #10 on: September 25, 2020, 06:31:00 pm »
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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[Buddie]

Re: FDA finally put black box warning on all benzodiazepines
« Reply #11 on: September 25, 2020, 06:36:14 pm »
Thos could be very dangerous to ppl on Benzos.

If they rapidly pull ppl off it will be a disaster.

« Last Edit: September 26, 2020, 02:22:24 pm by [Buddie] »
Suggestions, opinions and/or advice provided by the author of this post should not be regarded as medical advice; nor should it substitute for professional medical care. Consult your doctor before making any changes to your medication. Please read our Community Policy Documents board for further information.

[Buddie]

Re: FDA finally put black box warning on all benzodiazepines
« Reply #12 on: September 25, 2020, 06:48:21 pm »
I agree [...], 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.
Suggestions, opinions and/or advice provided by the author of this post should not be regarded as medical advice; nor should it substitute for professional medical care. Consult your doctor before making any changes to your medication. Please read our Community Policy Documents board for further information.

[Buddie]

Re: FDA finally put black box warning on all benzodiazepines
« Reply #13 on: September 25, 2020, 07:06:54 pm »
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 [...] 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
Suggestions, opinions and/or advice provided by the author of this post should not be regarded as medical advice; nor should it substitute for professional medical care. Consult your doctor before making any changes to your medication. Please read our Community Policy Documents board for further information.

[Buddie]

Re: FDA finally put black box warning on all benzodiazepines
« Reply #14 on: September 25, 2020, 09:37:19 pm »
https://www.nytimes.com/2020/09/23/health/benzodiazepines-fda-warning.html

“The agency also warned that people could become physically dependent on the drugs in a matter of days and might [...] difficulty stopping them safely. Withdrawal can take months, the agency said.”
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[Buddie]

Re: FDA finally put black box warning on all benzodiazepines
« Reply #15 on: September 25, 2020, 09:53:34 pm »
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
Suggestions, opinions and/or advice provided by the author of this post should not be regarded as medical advice; nor should it substitute for professional medical care. Consult your doctor before making any changes to your medication. Please read our Community Policy Documents board for further information.

[Buddie]

Re: FDA finally put black box warning on all benzodiazepines
« Reply #16 on: September 26, 2020, 12:14:44 am »
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.
Suggestions, opinions and/or advice provided by the author of this post should not be regarded as medical advice; nor should it substitute for professional medical care. Consult your doctor before making any changes to your medication. Please read our Community Policy Documents board for further information.

[Buddie]

Re: FDA finally put black box warning on all benzodiazepines
« Reply #17 on: September 26, 2020, 01:41:02 am »
AND require EVERY doctor to get a copy of the Ashton manual. Make a requirement in continuing education to [...] a course on tapering benzodiazepines and Z drugs.
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[Buddie]

Re: FDA finally put black box warning on all benzodiazepines
« Reply #18 on: September 26, 2020, 09:01:21 am »
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 [...] 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 [...] 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

[...]

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."
Suggestions, opinions and/or advice provided by the author of this post should not be regarded as medical advice; nor should it substitute for professional medical care. Consult your doctor before making any changes to your medication. Please read our Community Policy Documents board for further information.

[Buddie]

Re: FDA finally put black box warning on all benzodiazepines
« Reply #19 on: September 26, 2020, 06:25:08 pm »
You are right [...].  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 [...] 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 
Suggestions, opinions and/or advice provided by the author of this post should not be regarded as medical advice; nor should it substitute for professional medical care. Consult your doctor before making any changes to your medication. Please read our Community Policy Documents board for further information.