The Food and Drug Administration will now require its strongest warnings on the labels of certain prescription painkillers and anxiety medications, alerting doctors and patients about the risk of combining the drugs.

The new requirements for opioid analgesics (which include oxycodone and hydrocodone) and benzodiazepines follow a 41 percent increase in the number of patients prescribed both classes of drugs over the last decade and a resulting increase in overdose deaths in which they were used together. According to the FDA, such overdose deaths tripled from 2004 to 2011.

The agency is now requiring boxed warnings on the labels of opioids, explaining the danger of using the drugs in combination with benzodiazepines, and vice versa. Prescription opioid cough products will also be required to carry a warning about using them in combination with benzodiazepines.

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“Boxed warnings highlight the need for change, the need for increased care,” said Dr. Doug Throckmorton, deputy director at the FDA’s Center for Drug Evaluation and Research, in a call with reporters. “We think that’s going to reset the conversation about the use of these products together.”

More than 80 million US patients were dispensed prescription opioids in 2014, and 30 million received benzodiazepines, which are used to treat anxiety, insomnia, and muscle spasms. According to the agency, nearly 1 in 3 unintentional overdose deaths involve these two classes of drugs being used in combination. Throckmorton also said that at least half of opioid and benzodiazepine prescriptions received by the same person are prescribed the same day by the same doctor.

The risks in using these drugs together has been known for some time, FDA officials said, but new data on the number of emergency room visits and deaths prompted the agency to make Wednesday’s announcement. The requirements will apply to 389 products, according to FDA Commissioner Dr. Robert Califf.

Dr. Leana Wen, Baltimore’s city health commissioner and one of the public health officials who pushed the FDA to require stronger warnings, told reporters that prescribing the two drugs together had become routine clinical practice, despite there being “no scientific reason” to do so.

Somebody who was in a car accident might be prescribed an opioid for the pain and a benzodiazepine for muscle spams. Or a patient taking a benzodiazepine for their anxiety might then be prescribed an opioid and their doctor wouldn’t necessarily ask if they were on anxiety medication, Wen said.

“There is no scientific reason why in medical training I was taught to prescribe benzodiazepines and opioids together. Like many other things, clinicians and doctors do things the way that we do because it is routine care,” Wen said. “This is something that’s happened over the years not because of malintent, not because of a desire to do something wrong by the medical profession.”

The FDA is also issuing more detailed guides for patients explaining the risks of combining opioids and benzodiazepines and a public notice to push that information out to the public.

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  • I used to be on klonopin and norco but had to drop one. I dropped klonopin and since then, I have an extremely hard time sleeping and socializing. I don’t want to leave my house, ever. I used to be a social butterfly, as a pastor’s wife, but this year, I can count on 2 hands how many times I have gone to church. Chronic pain and anxiety are disabling. We have been discriminated against by the whole “opioid movement”. They have made us look like addicts and bad people because of those who have abused their medications or not been responsible for their medication. Hopefully they will quit overreacting to opioids. Any medication can be abused. That doesn’t mean you clamp down on it. I can’t tell you all the problems I have had because of this.

  • I do not understand there resing for doing this I have been taking this combination of meds for years and now they are cutting way down on Xanax I can get to less than half of what I used to take over a period of time ay this time am coping barely with anxiety problems if have to go lower don’t know what to do except the best I can you know I don’t drink, smoke, or take anything except what Dr. gives me and as directed and I get everything from same Dr. I will just keep praying only thing can do

  • I am very upset about this. I have been taking xanax for panic attacks. I receive 20, 1 mil pills , every six months. But because I take 4 tramadol and a 5 mil hydrocodone a day for my arthritis pain, I get cut off. I have been doing this routine for years. I work full time, I walk 30 miles a week , I do not smoke or drink. I dont think I should be punished for someone’s else’s overdose. And I dont think 20 xanax, every six months is excessive, at all.

  • I know how everybody that commented before me feels I have been on xanax 1mg. and hydrocodone 10/325 for years started out at lower dosage to start with it all started in 79 when I was 25 ruptured a disk in back they said it wrapped around spinal cord I don.t know only thing I know is my left leg was not working right they cut disk out sewed me back up still hurt never quit insurance sent me to another Dr he said I had scar tissue built up causing me to hurt so he cut me open did whatever did not help insurance Comp.sent me to specialist over 200 mile aways they did all kinds of tests including a writing test to see if I was faking it well to make a long story short they said I was hurting but they did not know why the last Dr. that operated on back said I was just lazy and that I told him I wanted him to cut my back open needless to say after he gave me scrip for pain med.and told me to find another Dr. I got to waiting room door I told him what he was .to shorten this up tried for disability they told me I was to young and to light so i started hunting some sort of job finally found one making min wage in 81 working for senior citizens center mowing grass the old people around the county needless to say hurt back again went to Dr.gave me pain pills keep working and going to drs for ten years and Dr. and people told me I could no longer work so they put me on workmans comp. and I started trying to get disability again insurance gave me money labor part of workmans comp tried to start up small car repair shop and body shop needless spent money but could not keep repairing cars finally told Dr. I needed to see another type dr around 92 he got me in a pain and psychiatry Dr he put me on xanax and keep me on pain med. plus another one keep seeing him and finally got disability in 94so in other words Have been on xanax around 92 then all of a sudden they are going to kill me I say B/S but the gov. knows best bull tried to talk to dr but he say got to get me off he just cut me down again I was cutting myself down had gotten myself cut down from 4 mg. a day t 2.5 now he decided it was time to cut me down to 1.5 i know first time I feel bad going to be in his office and he want like me to list off my problems I have had another back opp. c1l5 disk ulmer nerve relocation,prostat remove because of cancer myeloma removed from chest both hands worked on left knee replaced high blood pressure inherited high cholesterol anxiety attack arthritis in hands feet back two pinched nerves in back that most of it everybody do like me just keep praying

  • I might be the exception to the rule. I suffer from a rare, severe form of Parkinson’s syndrome. It includes muscle spasms and severe pain. I need both Clonazepam and Tramadol to control these symptoms. Fortunately for me, Tramadol acts as a stimulant on me. So I won’t have trouble breathing.

    • What kind of Parkinson’s do you have if you don’t mind? I’m on that exact regiment (and I’m 29 years old) but Parkinson’s runs in my family. This may be something to bring to my doctors attention.

  • I don’t know where to start , for I already have issues to deal with . My belief is that this is not right . I know my life was never important to anyone , meaning to who put me on all this medication . I been dealing with pain for number of reasons , and naturally I did sick help , and of course we go to doctors and not someone on the street cause they supposed to know what they doing , what they giving us , and we trust that they will do what’s good for us . I was never person that like medication , but when I go to see doctor they always say I can’t help you if you don’t follow orders , so I , for one had no knowledge ( I’m not doctor , I don’t have that diploma that states that I have finished school for being doctor and “handling ” medication ) . I’m taking at least 16 different medications for last decade or longer, few of them two decades . I was never in fear that one of them will kill me cause it’s taken with another . Why??? Cause I trust my doctors , I trusted that they will never put my life in risk . Well , seems like I was wrong , for the same doctor that put me on one medication , now , after decade or so telling me that I’ll die cause I’m taking it . And when I ask if I should stop , she’s telling me that’s not opinion , to take less , not option either . What to do ? Keep doing what you do and wait for dead . I asked why she put me on that medication at first place if is gonna kill me . And she said seemed ok then . Now I don’t know what to do . Called my pharmacy and talked to pharmacist . Told them what my doctor told me , hoping to hear reassuring reply . But , to my shock , she didn’t say I will die , but she did say that my breathing will slow down and that complicated everything . I don’t know how can they still be practicing like they did nothing wrong. Why is no one doing anything to help us , patients who are stuck and pretty much have no way out . I , really have no idea what to do . I even asked my doctor to send me to hospital to get me if medication and she none sholantly said , no one would pay for that . Who gave them right to play with anyone’s life ? Who???
    I need help , but don’t know where to find it , where to look for , more less where to find it .

    • Ada,

      That is the thing … these medications AREN’T going to kill us, or they already would have. What CAN kill us, is when doctors start taking medications away that we have been taking for a decade. That is what makes this all so absurd. Many of us have been taking these meds for years, with no problems, but now because of this new warning, they are insisting on making changes.

  • my husband and i have taken hydrocodone and xanax togeather for years and now they are saying we cant we have to decide if you want to sleep or not be in pain aint that a bitch i have never took one more pill than i was supposed to in a day and i just turned 71 and having a lot of issues and they want us to decide which one we want the one for pain or the one to help with anxiety my mother took xanax for years and never had a problem and now people who misuse medicines and steal them and overdose on them are making my life unbearable the first thing to decide is if i want to be pain free or sleep aint that a bitch i have taken both of these medicines for years and never had a problem and now i know i will go through a living hell not being able to have both their is something wrong with this picture each medicine for each person should be looked at and decided if that person is abusing it dont punish me for what someone else is doing been going through hell trying to go without hydrocodone and xanax doesnt take away pain nor make you sleepy when you hurt from head to to all i am saying it should be an individual thing not just snatch someones life away because of what someone else is doing my husband and i are both miserable and in pain that xanax will not take care of my mother took xanax for years god love her hope well to all that is in our situation dont know what i will do go crazy i guess thanks dea for picking on an old woman who has tried to be a good person all her life god bless all and have a good day all shelby in ga

  • I totally agree with these ladies. I have been on both medications for many years, and now some none caring meathead that has no idea what I deal with says it,s unsafe. You would think after years with absolutely no problems you would make exceptions, or grandfathered in, or something. You can’t study a bunch of addicts and make generalizations that affect everyone. I agree it doesn’t need to be just general practice, but there should be exceptions.

  • She’s right!!!!! I agree with everything she’s saying n I’m so so sorry for your loss .I could only imagine what you’re going through. I too have rheumatoid n spinal stenosis n other problems. You should receive both just try not to take them together. These drug addicts n thieves need to b dropped
    . There are people like us who actually are in pain I too have chronic back pain n legs hurt my neck. My PT has said that I basically hurt all over. You can take both because you definitely need both . My neurologist told me I was on the perfect combination of meds. I just want you to know this… God loves you .Talk to your primary care doctor. Prayer also helps. God Bless You

  • I’m having the same exact problem! How are we supposed to function on a daily basis? I’m 59 years old. I’m in constant pain from multiple back surgeries. On top of that I have both osteoarthritis and rheumatoid arthritis. I’m single and totally disabled and have had 3 nervous breakdowns starting in 1985, all of them major one’s. I’m in a wheelchair from the back pain and I can’t stand up by myself for over 2 minutes at a time. Since I’m totally disabled I’m only able to receive $1199 income a month from my SSA so for one thing, only one of the reasons I’m so very stressed out with worries is whether or not I’ll be able to pay all my bills from all the extra medical costs that aren’t covered from my insurances. I am a very responsible person and if I wanted to commit suicide there are so many other ways to do that but it’s wrong and I’d never even consider it, if I was I think I would going to do it I’d of done it 19 years ago when my ONLY SON! My 9 year old son was murdered by a classmate the same age of 9 years old. He was shot in the face by this boy and because he was only 9 years old Illinois law forbids him from being prosecuted. Since my psychiatrist took me off the clonazepam and tried alternative medications and they all make me sick as a rabid dog, and she even wanted to put me back on seroquel (a medicine for lunatics, if someone asked you for matches so they could set your house on fire with you in it, you’d be Yeah here you go and without any recollection of even saying it) in October 2018 until now June 11th 2019. I can’t eat because my stomach is in knots from being so stressed out. I’ve went from 236 lbs to 155 lbs and still losing weight. My family doctor can’t figure out what’s causing it except for my nerves but doesn’t feel comfortable prescribing me the clonazepam because of the FDA which was working wonderfully for me! I’ve had every test possible to figure out what the problem is to no other conclusion except my nerves. She asked about sending me to another psychiatrist but they all want me to go to counseling and relive all the horrible experiences I’ve been through just to give me the same medications that do not work I’ve already tried them all and beside, I’m trying to move forward with life not to keep dwelling on how I got this way to begin with. There’s nothing to gain and nothing that’s going to make me feel better about what’s happened or how I feel about it all. I need the clonazepam back it’s the only medication that helps me cope and deal with everyday life. All the other medications for OA & RA medications also have opioid in them to. So now I’m screwed. I feel like a rat in a maze because of the FDA’s new rules and the damn drug addicts. I’ve never asked or tried to refill any medications early, nor have I ever reported any of them lost or stolen to try and get more than I need. It’s not right that people in our conditions should not have to suffer because the FDA thinks all people are the same. People like us need both medications to live our lives as close to normal as it gets!!!

    • I totally agree with you. God help you. I have not suffered the loss you have. I can’t comprehend how you feel. I also have had nervous breakdowns. I have been on medication for over 40 years and still struggle with being in public. Five years ago I was diagnosed with RA and Osteoporosis. I have had 7 spinal fractures. Some now but because my bones are so brittle I can’t have any more. They have changed my pain meds because of the combination of both medicines. I stay so sick from the pain. My family doctor knows I would never commit suicide. I always take the medicine 3 hours apart. But I hear others brag about how much medicine they get. But honest people who for real is in pain suffer. Sometimes I think because I have a mental illness I am discriminated against. Trust me I would love to be like normal people. I just don’t think it’s fair. If they would look at the individual it would be different. But evidently that’s too much work for the doctors. They need to do their job so we can have a quality of life.

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