Author Topic: FDA finally put black box warning on all benzodiazepines  (Read 1252 times)

[Buddie]

FDA finally put black box warning on all benzodiazepines
« on: September 23, 2020, 11:48:55 pm »
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, FDAís 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 patientís 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 [...] 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.
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 #1 on: September 24, 2020, 03:21:44 am »
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 [...] 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 canít anyone seem to get the info right and correct the misleading language used when talking about the use, prescribing and damage these drugs cause. Weíre 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 itís 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!'



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 #2 on: September 24, 2020, 04:16:45 am »
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.
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 #3 on: September 24, 2020, 07:49:28 am »
I hope this helps to save some people; even if itís a few lives. The less people on these drugs the better. Hopefully some Drs will be influenced by this.
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 #4 on: September 24, 2020, 11:51:19 am »
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 [...] any rules against that.

And the FDA thinks that it only takes months, and not years. And they don't [...] 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.
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 #5 on: September 24, 2020, 03:27:16 pm »
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 [...] 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 [...] 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.
« Last Edit: September 24, 2020, 03:41:10 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 #6 on: September 24, 2020, 04:46:37 pm »
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.
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 #7 on: September 25, 2020, 12:23:59 am »
Can someone provide me a link to the actual new warning?  All I see is descriptions of a new warning. 
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 #8 on: September 25, 2020, 01:55:50 am »
Can someone provide me a link to the actual new warning?  All I see is descriptions of a new warning.

I think you will find here under additional information  for patients

https://www.fda.gov/drugs/drug-safety-and-availability/fda-requiring-boxed-warning-updated-improve-safe-use-benzodiazepine-drug-cla
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 #9 on: September 25, 2020, 04:55:34 pm »
also , the FDA is only the USA,, what about the rest of the world?  so this really wont do much,
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.