Side Effects of Xanax, Other Benzos Receive FDA Black Box Warning About Addiction And Abuse Risk
A class of drugs known as benzodiazepines, which includes the popular brand name drugs Xanax and Valium, must now carry a prominent boxed label warning about the risk that side effects may include long-term addiction and misuse.
The FDA issued a news release on September 23, announcing a new “black box” warnings for benzodiazepines. The agency is also recommending healthcare providers prescribing the medications limit the dosage needed to achieve the desired therapeutic effect and to be cautious of simultaneously prescribing of opioids.
Xanax, Valium and other “benzos” are designed to work on the brain’s neurotransmitters, causing sedative and hypnotic effects that are often used to treat generalized anxiety disorder, insomnia, seizures, social phobia, and panic disorders.
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Learn MoreOfficials estimate 92 million benzodiazepine prescriptions were dispensed in the United States in 2019, with Xanax being the most common, followed by Klonopin, lorazepam Intensol and Ativan.
Recent research suggests patients may become physically dependent on benzos, after only a few days of consecutive use, which could make the withdrawal period following stoppage potentially deadly. FDA officials warn stopping benzodiazepines abruptly or reducing dosage too quickly may cause acute withdrawal reactions, resulting in life-threatening seizures.
The FDA and National Institute on Drug Abuse have identified trends linking the use of benzodiazepine to the increased risk of using opioids, as well as a trend in overdose deaths involving the concurrent use of both medications. According to the research, more than 30% of overdoses involving opioids also involve benzodiazepines. The agency warns both drugs are designed to sedate users and suppress breathing, which can lead to an overdose death.
“While benzodiazepines are important therapies for many Americans, they are also commonly abused and misused, often together with opioid pain relievers and other medicines, alcohol and illicit drugs,” FDA Commissioner Stephen M. Hahn said in the press release. “We are taking measures and requiring new labeling information to help health care professionals and patients better understand that while benzodiazepines have many treatment benefits, they also carry with them an increased risk of abuse, misuse, addiction and dependence.”
As a result of the increased risks of overdose and dependency from side effects of Xanax and other medications in the class, the new FDA Boxed Warning for all benzodiazepines medications will now alert prescribers and patients to the risks of abuse, misuse, addiction, physical dependence and withdrawal reactions.
As part of the FDA’s ongoing effort to minimize the risks of controlled substances, the agency has also issued changes to the to the Warnings and Precautions, Drug Abuse and Dependence and Patient Counseling Information sections of the prescribing information for all benzodiazepine products.
The FDA instructs healthcare professionals to consider a patient’s condition and assess their risk of abuse, misuse and addiction, and if necessary to limit the dosage and duration of each drug to the minimum needed to achieve the desired clinical effect.
Prescribing doctors are also being warned to take precautions and closely monitor patients issued benzodiazepines in conjunction with other addictive medications, such as opioids. Benzodiazepines patients should never abruptly stop taking the medications and should talk to their doctor about a gradual dosage decline plan to prevent withdrawal and possible life threatening seizures.
In 2016, the FDA issued a black box warning about co-prescribing benzos with opioids, indicating when taken together the risk of death greatly increases. Researchers indicated benzodiazepines, like Xanax and Klonopin are among the 10 most commonly prescribed psychotropic medications in the United States.
The heightened risk of benzodiazepine patients becoming addicted to opioids is a major concern among health officials, as the U.S. is currently still struggling with an opioid crisis. The U.S. Centers for Disease Control and Prevention (CDC) reports more than 70,000 drug overdose deaths occurred in the country in 2017, with 68% involving an opioid painkillers. Of those, 60% involved synthetic opioids like fentanyl.
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10 Comments
JodyNovember 27, 2022 at 2:24 pm
I was on Xanax 8mg a day 4 bars a day for good 12 years my doctor retired and new doctor cut me to 1.5 MG then to nothing and I was never told I feel like am dieing all can of problems is going on this is 5th day with out any it gets hard to breathe I start sweating feels like my skin going to peal off my body my legs is going crazy am seeing things that ant there like something in corner of my ey[Show More]I was on Xanax 8mg a day 4 bars a day for good 12 years my doctor retired and new doctor cut me to 1.5 MG then to nothing and I was never told I feel like am dieing all can of problems is going on this is 5th day with out any it gets hard to breathe I start sweating feels like my skin going to peal off my body my legs is going crazy am seeing things that ant there like something in corner of my eyes I know nothing there cause my dog don't see nothing my hands crap up feels like got bugs on me at times and ant even going say to much about my butt being like a water hose and am still having more problems am starting to get a taste of like metal or something like that in my mouth I hope someone sees this and it stops them from ever listening to doctor and just talking what they say and not knowing about all the problems
SuzanneSeptember 11, 2022 at 1:40 pm
My 26 yr old son was given valium for anxiety, a month later paxam and lyrica all from a GP. He did not ask for the drugs. He was not depressed. He committed suicide within 36 hours of taking the Paxam with the Lyrica. We had no warning. The doctor is culpable in the murder of my son. He had his life ahead of him - done his master in Prof Chemical Engineering with high distinction and was the bea[Show More]My 26 yr old son was given valium for anxiety, a month later paxam and lyrica all from a GP. He did not ask for the drugs. He was not depressed. He committed suicide within 36 hours of taking the Paxam with the Lyrica. We had no warning. The doctor is culpable in the murder of my son. He had his life ahead of him - done his master in Prof Chemical Engineering with high distinction and was the beautiful person you could ever meet. He should never have been given these drugs. Australia is ripe for a massive class action. It's the wild west - lawless administering of these deadly drugs. No warnings on any of the packaging. No informed consent. 3/4 of doctors self medicating. The TGA regulatory body owned by Big Pharma. Coronial Courts not doing complete toxicology - not testing for lyrica in the blood. It is so corrupt. Morgues are full and something is in these anti depressants and anti anxiety pills that are having people kill themselves very quickly. National suicide deaths NOT reported since Dec 2020. Window of opp to sue for medical negligence is 3 years and Coroner's Court still processing sudden and unexpected deaths from 2019. Australia is ripe for a massive class action. You could start with Lyrica. Massively exposed. They don't seem to care at all.
MichaelApril 25, 2022 at 5:13 pm
prescribed Xanax for 20+ years maximum dose age for GAD and PTSD and now told i have brain damage from it. insurance wont approve referrals for scans to find out how much damage. i cannot work. hard to do daily functions they say it causes dementia. I need a lawyer so my family is taken care of.
LeAmberApril 7, 2022 at 6:14 pm
The FDA is full of shit!! They make it out to be that the people harmed by benzos are just people who abuse medications only… when the REAL truth is that the government has known about the danger of benzos FOR DECADES!!! None of thes meds are safe to be taken for long at all get people are put on them by their doctors for years… decades!! And it almost ends up having to be this way because to come[Show More]The FDA is full of shit!! They make it out to be that the people harmed by benzos are just people who abuse medications only… when the REAL truth is that the government has known about the danger of benzos FOR DECADES!!! None of thes meds are safe to be taken for long at all get people are put on them by their doctors for years… decades!! And it almost ends up having to be this way because to come off of them CAN either end your life for you OR cause you to end it yourself because it leaves you SERIOUSLY injured and stripped of EVERYTHING!!! To be on it causes severe psychosis amongst other mental health issues like bi polar and so on… and to come off them can create a withdrawal hell that some of us have been living through for YEARS now with no end in sight.. our brains are injured and life will never be normal for us again… and YET the FDA has the balls to act like it’s a personal misuse or abuse problem… what a joke
AlishaOctober 15, 2021 at 9:07 am
My brothers doctor gave him Concerta and Clonazapam fir his ADHD and severe anxiety 4 months ago. He took his life Sept 25th. He loved life and his two small children. He never would have done what he did!
jessicaOctober 4, 2021 at 10:30 am
I was prescribed clonazepam for years and was never offered any other options for alternative medicine for my anxiety. I felt that I couldn’t stop the medicine because when i missed a pill or two I had really bad anxiety. Also I was afraid to stop the medicine because of the chance of serious effects to stopping. I feel that my phsyciatrist over prescribed clonazepam to me but at the time thought [Show More]I was prescribed clonazepam for years and was never offered any other options for alternative medicine for my anxiety. I felt that I couldn’t stop the medicine because when i missed a pill or two I had really bad anxiety. Also I was afraid to stop the medicine because of the chance of serious effects to stopping. I feel that my phsyciatrist over prescribed clonazepam to me but at the time thought I had no other option to handle my anxiety
StevenAugust 25, 2021 at 12:05 pm
Yes benzodiazepines are very bad drug to be on for multiple years I was on Klonopin for 10 to 12 years for my epilepsy 1 mg twice a day. Never abused it. How horrible memory problems.
Rev MichaelAugust 18, 2021 at 4:48 am
in January of 2018 I had one of the painful cervical surgeries I’ve ever had. Being released and sent home in excruciating PAIN 5 days later my condition got worse. I was instructed to go back to my hospital for an emergency CT Scan I’m the first 5 minutes they found the problem. One the hardware they applied to neck was obviously defective because instead of going straight it went sideways into [Show More]in January of 2018 I had one of the painful cervical surgeries I’ve ever had. Being released and sent home in excruciating PAIN 5 days later my condition got worse. I was instructed to go back to my hospital for an emergency CT Scan I’m the first 5 minutes they found the problem. One the hardware they applied to neck was obviously defective because instead of going straight it went sideways into my SPINAL CORD. The next morning I had to go through the most painful surgeries of my life: however I had some nerve damage. My surgeon was Dr John C Steck of Culichia Neurological Institue. He is close and dear FRIEND! Shortly after this in April or May of 2018 I was informed by Dr Steck that he could no longer continue prescribing me (Valium). I really didn’t make a big deal I mean Valium is like Tylenol and Aleve a common drug it the USA. 2 months later I went into acute insomnia. However everyone even my family immediately jumping on and accusing me of opiod addiction. Millions of people went through the most painful agonizing withdrawal symptoms. I was abandoned in my home because no one wanted to help me: being that all assumed it was because of opioids. The discontinuous of Valium COLD TURKEY: no tapering, no medical help whats so ever. My hospital records noted and the Pain Management Dr Colvin chief pain management doctor West Jeff Hospital diagnosed me a phycotic being I was on record of no sleep none not even dosing off of 5 DAYS that I was now phycotic. I was yelled at screamed at and abandoned. I was admitted in 2 Behavioral Heath Hospitals twice. Only to be discharged in 4 days and released on these hrounds(I didn’t belong there because I was diagnosed with a SOUND MIND. 2 1/2 years of HELL TORMENT AND REJECTION. The FDA is hiding this info because they know all to well what was and is happening to millions. I was Cold Turkeyed after 14 yes I said 14 years on Valium. It’s never been just opioids because I would dare to say it’s been and still is the sudden abrupt discontinuous of benzodiazepines. 5 weeks ago with a HEART ATTACK, but let’s not forget that in the middle of the withdrawals I was diagnosed with TAA Thoracic Aortic Aneurysm. SO WHY ISNT ANYONE HELPING US? I LOST MY WIFE MY FAMILY AND 2 WEEKS AGO MY HOME IF 30 YEARS. PLEASE SOMEONE HELP US! THIS AS REAL AS IT GETS 08/17/2021
DianneJanuary 4, 2021 at 8:08 pm
I was prescribed clonazepam in 1990. Can I sue my old doctor? Can I join a class action somewhere in Canada? My doctor kept me on these benzos for 20 years on a large dose. I have impairments from this drug now. I cannot work and am living in poverty. Thank-you.
LauraDecember 18, 2020 at 11:36 am
Please help paws 3 years out. I mourned my old life , my life.