FDA Orders Stronger Warnings on Benzodiazepines
https://www.medscape.com/viewarticle/937997
The US Food and Drug Administration (FDA) wants updated boxed warnings on benzodiazepines to reflect the “serious” risks of abuse, misuse, addiction, physical dependence, and withdrawal reactions associated with these medications.
“The current prescribing information for benzodiazepines does not provide adequate warnings about these serious risks and harms associated with these medicines so they may be prescribed and used inappropriately,” the FDA said in a safety communication.
The FDA also wants revisions to the patient medication guides for benzodiazepines to help educate patients and caregivers about these risks.
“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, MD, said in a statement.
“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,” said Hahn.
92 Million Prescriptions in 2019
Benzodiazepines are widely used to treat anxiety, insomnia, seizures, and other conditions, often for extended periods of time.
According to the FDA, in 2019, an estimated 92 million benzodiazepine prescriptions were dispensed from US outpatient pharmacies, most commonly alprazolam, clonazepam, and lorazepam.
Data from 2018 show that roughly 5.4 million people in the United States aged 12 years and older abused or misused benzodiazepines in the previous year.
Although the precise risk of benzodiazepine addiction remains unclear, population data “clearly indicate that both primary benzodiazepine use disorders and polysubstance addiction involving benzodiazepines do occur,” the FDA said.
Data from the National Survey on Drug Use and Health from 2015 to 2016 suggests that a half million community-dwelling US adults were estimated to have a benzodiazepine use disorder.
Jump in Overdose Deaths
Overdose deaths involving benzodiazepines jumped from 1298 in 2010 to 11,537 in 2017 — an increase of more 780%. Most of these deaths involved benzodiazepines taken with prescription opioids.
Before prescribing a benzodiazepine and during treatment, a patient’s risk for abuse, misuse, and addiction should be assessed, the FDA said.
They urge particular caution when prescribing benzodiazepines with opioids and other central nervous system depressants, “which has resulted in serious side effects, including severe respiratory depression and death.”
The FDA also says patients and caregivers should be warned about the risks of abuse, misuse, addiction, dependence, and withdrawal with benzodiazepines and the associated signs and symptoms.
Physicians are encouraged to report adverse events involving benzodiazepines or other medicines to the FDA’s MedWatch program.
Filed under: General Problems
I really think it’d save everyone a lot of time, money, madness, & effort if they just banned ALL medications of ANY kind, Rx or OTC. Anything can be dangerous or fatal if taken the wrong way or abused. Drinking too much water can kill you –they even call it “water INTOXICATION” so obviously the pathetic excuses for citizens do it to try & get high. We must eradicate all water sources, both within the home & in the larger world without.
And don’t even get me started on alcohol; according to the NIH, about 88,000 people died from alcohol abuse in 2018.* The actual fact is, there’s really no beneficial use to alcohol (“But I like wine/beer/booze” doesn’t count) as there unquestionably is for pain medications. Alcohol is the 3rd largest cause of death in the US: 1st is tobacco, 2nd is “poor diet & physical inactivity” (I assume that’s a sensitive, non-offensive way to avoid saying “obesity”). If you look at the leading causes of death in the US according to the CDC, opioids (legal plus illegal) aren’t even in the top ten.**
I’ve been a scientist my whole life, have a deep need for policy decisions to be based on FACTS, not hysteria. Of course, i’ve been disappointed my whole life, but never so much as in the last 5 years or so. I am truly losing my mind. It’s clear the whole country is not so much losing their minds, but unscrewing their skulls & scooping out brains by the hand full…the only explanation I can come up with for the deadly situation people in pain find themselves in.
*https://www.niaaa.nih.gov/publications/brochures-and-fact-sheets/alcohol-facts-and-statistics#:~:text=Alcohol%2DRelated%20Deaths%3A,poor%20diet%20and%20physical%20inactivity.
**https://www.cdc.gov/nchs/fastats/deaths.htm#:~:text=Number%20of%20deaths%20for%20leading%20causes%20of%20death%3A&text=Accidents%20(unintentional%20injuries)%3A%20169%2C936,Alzheimer’s%20disease%3A%20121%2C404
All true.
Thank you “dear” government for telling my Dr and me what is best for my health. I had to choose between getting some sleep at night or being in pain. I chose having my pain treated. Mind you that for over 10 years I was able do do both with some moderate relief and no issues. Now I lay awake way into the night and finally doze off into the late hours of the morning. I feel this restriction has probably driven more people especially seniors to alcohol which has a greater risk than a low dose of Ambien or Klonopin. The government has stuck its nose into, too many things it knows nothing about.
All of those Reps know a ripe MARKET when they see one, we know that much…
What kind of fool would pound their opiate down with too much benzo?
Obviously this is illicit use again, or what I call “the fatally clumsy”. In other words, NOT legitimate sufferers simply trying to get a leg out of a boiling pot.
There is an facet to all of this that implicates also Doctors as equally responsible for these medication tragedies.
In other words they (The Government, now deeply entrenched and almost in complete control of ‘health care’) wants to knock every thing out that might cause us to leave the track of revolving doors of ‘health care’ facilities. Any building containing a ‘Doctor’. Interestingly, at the same time, I notice, at least, that almost all diagnosis and ‘treatment’ is wrong the first time or the 25th time.