Requesting Changes in Benzodiazepine Labeling
CDER Benzodiazepine Labeling closed
2010-08-04 2013-04-04 2010-05-12 2010-03-08 2010-04-05 2010-04-22 2010-05-12 2010-05-14 2010-03-09 2010-03-12
FDA-2010-P-0091-0060 FDA-2010-P-0091-0112 FDA-2010-P-0091-0040 FDA-2010-P-0091-0006 FDA-2010-P-0091-0028 FDA-2010-P-0091-0034 FDA-2010-P-0091-0038 FDA-2010-P-0091-0043 FDA-2010-P-0091-0008 FDA-2010-P-0091-0016
04:00:00 04:00:00 04:00:00 05:00:00 04:00:00 04:00:00 04:00:00 04:00:00 05:00:00 05:00:00
https://api.regulations.gov/v4/comments/FDA-2010-P-0091-0060 https://api.regulations.gov/v4/comments/FDA-2010-P-0091-0112 https://api.regulations.gov/v4/comments/FDA-2010-P-0091-0040 https://api.regulations.gov/v4/comments/FDA-2010-P-0091-0006 https://api.regulations.gov/v4/comments/FDA-2010-P-0091-0028 https://api.regulations.gov/v4/comments/FDA-2010-P-0091-0034 https://api.regulations.gov/v4/comments/FDA-2010-P-0091-0038 https://api.regulations.gov/v4/comments/FDA-2010-P-0091-0043 https://api.regulations.gov/v4/comments/FDA-2010-P-0091-0008 https://api.regulations.gov/v4/comments/FDA-2010-P-0091-0016
Anonymous Anonymous Anonymous Anonymous Anonymous Anonymous Anonymous Anonymous Anonymous Anonymous
Anonymous Anonymous Anonymous Anonymous Anonymous Anonymous Anonymous Anonymous Anonymous Anonymous
This person Jenelle commented I understand that people have addiction problems to these meds but because these meds are looked at as being so addictive I have not been able to get the help I need for my anxiety which makes my lupus even worse all they prescribe me is serequel. ***It sounds like she is confusing addiction/abuse with physical dependency and withdrawal. Serequel also has many side effect, anxiety being one.She said Id rather be addicted to benzos than not be able to work, go out, or even look at people in there eyes without having an anxiety attack.***If Jennelle gets addicted/physically dependent on Benzes not looking people in their eyes will be a walk in the park compared to the incapacitating withdrawal symptoms that have made people have to leave their jobs do to intense life altering withdrawal symptoms which are both physical and mental in nature and can last months and years in some cases, some people are never the same do the changes the drug causes once physical dependency has occurred. I would be hell dealing with benzodiazepine withdrawal on top of Lupus, what nightmare. Concerning benzodiazepine drugs:My story:  I have been on Xanax for years, so many that I cannot remember when I started.  My doctor never told me about physical addiction all those years.  My current Nurse Praticioner gave me only meger information on how to withdraw from this drug.  She did not mention anything about phyical addiction, and so now I am in the withdrawal phase.  I have gone through the worst part of the withdrawal, and now I am in a protracted stage, and I do not know when the withdrawal will be finalized.  And I was on only 0.5mg per day, a rather low dosage, but having taken this Xanax drug for years, I have become physically addicted to it and now am in withdrawal.  This Citizen Petition should be taken seriously by the FDA, and not put aside.  It was the FDA that approved the drug Xanax, and the FDA needs to alter that approval with guidelines on its use and the use of other benzodiazepine drugs.  The FDA has a responsibility to the citizens of the United States of America to insure that the citizenry has full knowledge of these drugs as to their use together with warnings about addiction.   Please consider this petition carefully.  Your attention to this matter could reduce much preventable suffering, as well as substantially reduce health care costs caused by unnecessary prescriptions and the ineffective treatment of prescription-caused problems as though they were an independent problem. I have been on Klonopin 12 years-was never told it was addicting by any of the 4 doctors I have seen. I should have been given an informed consent to sign. Im a French citizen, member of the Yahoo benzo group, the French Yahoo benzo group, and the Yahoo benzo protracted group.Benzodiazepines have completely destroyed my life. They were first prescribed to me as a sleeping aid while I was trying to give up smoking  I suffered very bad psychological adverse effects while on them and my life started to fall apart but that was nothing compared to what I was about to go through.All hell broke lose when I tried to get off them (after 2 and a half years of use). Ive experienced more than a hundred symptoms, both psychological and physical, and a dramatic cognitive deterioration. Because of these drugs, the lively young woman I was became a homebound invalid. I was 26 years old when first prescribed benzodiazepines and had my whole life ahead of me. At 32 years old and 31 months off benzodiazepines, I cant get out of bed (or sit up in bed) 90% of the time. I suffer from excruciating joint pain day in and day out, debilitating fatigue, gastrointestinal issues, and a vast array of neurological symptoms. I cant work, cant drive, cant read, cant take care of my home, or even of myself. Everyday I wake up to that agonizing state, wondering how such a dangerous drug can have been be prescribed so lightly for decades.Besides I get little to no help from my doctors whom I have to educate on the issue. What I suffer from  benzodiazepine protracted withdrawal syndrome  isnt known by the French medical authorities. The French usually wait for an FDA ruling to start changing their own prescription habits. I implore the FDA to take action on the matter  those benzodiazepines can cause absolute mental and physical torture and we must shield the generations to come from this terrifying plight. I am in support of this petition.  I was prescribed klonopin for insomnia in 2005.  After 3 months I tried to wean off.  It took me several years.  I have been off of the medication for almost 18 months and still have some severe neurological issues that were not present before the administration of this medication. Please support the changes to the labelling on benzodiazapines.  They are very diffiult to withdraw from and can cause permanent damage.  Unfortunately, most people are not adequately informed of the risks. I am a elementary school principal who was misdiagnosed with a brain aneurism last year.  I was given ativan, a benzo, to handle the stress and was addicted and having side effects after one week.  I suffered through three months of withdrawal.  This was the worst experience in my life. I was given ativan with no information that for some people it was highly addictive.  I was treated poorly by health professional who didnt read literature and only knew what pharma sales people told them.  These drugs should be outlawed. I am a mental health professional and a former consumer of benzodiazepines (bz). I have spent the past 4 years moderating an online bz withdrawal (wd) and recovery support group with members hailing from all corners of the world and whose lives have been negatively affected the bzs. One thing we all share in common is that our Drs never informed us about how addicting these drugs were, even within as little as 7 days use, nor were we alerted to the effect these drugs could have on our overall health and well-being. Four yrs ago and after 16 yrs of daily use as prescribed I was instructed by a Dr to discontinue 10mgs of Klonopin (equiv to 200 mgs Valium) cold turkey. I never abused this drug. For the next 4 months, I was incapacitated by the wd this produced. But that was hardly the end of it. While I am happy to report that I am mostly well at 4 yrs off, I still experience a grocery list of symptoms characteristic of bz wd. And while this event proved to be a defining moment in my life, it was, and remains, the most violent and traumatic thing I have ever experienced in all my 53 yrs. This drug robbed me of 16 vital yrs right out of the center of my life, yrs which I now have very little memory of due to the effect of the drug. The disturbing part to me is that during that time, I could not see what was happening to me nor could I see the deterioration occurring in my health, this from the effect the drug was having on my brain. Moreover, this unnecessary and devastating loss could have easily been avoided had I simply been informed about the inherent risks and dangers that come with taking this class of drugs. PLEASE, hear our voices. Inform Drs and consumers by distributing educational material, posting warnings and appropriate, clear prescribing/withdrawing guidelines. The personal, social, economic and spiritual ruin this class of drugs is bringing to the lives of consumers and to that of their loved ones is pervasive and, again, wholly avoidable. Thank you. My physician prescribed 10mg valium for a short trip for motion sickness prevention and jet lag.  He did not warn me to taper off it slowly nor that after three weeks of taking valium that I could develop a dependence.  Three weeks after my trip and abruptly stopping valium, I ended up with severe anxiety, vertigo and palpitations that brought me to the Emergency Room of a local hosptal.   The ER physician did not understand that valium takes three weeks to process out the body unlike shorter acting more in benzos like ativan or xanax.  Finally found an otoneurologist who understood the problem.  He informed met that 2mg would have been the correct dose rather than 10mg and that they always advise patients to taper even 2mg slowly.  Could have saved thousands of dollars in medical tests and emergency room costs.  Within five days of putting me back on low dose valium, the vertigo subsided (whereas several friends who had vertigo in recent years took a month or longer for the dizziness to subside from vertigo).  Next doctor tried to tell me I could go on lexapro and three weeks later stop the valium cold turkey.  Again, another misinformed but well meaning doctor.  I tried to cut several milligrams from the valium as suggested but did not take the lexapro.  High anxiety and I was concerned about vertigo returning.  Only after I found a  benzo support forum based in the United Kingdom (benzobuddies.org) did I get proper information on how to slow taper off the valium.  FDA needs to get involved here to instruct doctors and patients about dangers of many classes of benzodiazepenes and stop throwing antidepressants and other meds to add when what is needed is education about how to taper slowly off the benzodiazepenes.  Also, friends of mine have been handed out xanax and klonopin like candy without any warnings.  they were horrified to read about it on the internet.  Psychiatry is doing a disservice when it comes to this wanton behavior regarding benzodiazepenes.