Fda Issues Strongest Warning For Combining Opioids And Benzodiazepenes

In an announcement on August 31 (2016), the FDA declared that they are adding Boxed Warnings to the drug labeling of prescription opioid and benzodiazepene medications.

They are urging health care professionals to limit combining such drugs to cases where alternative treatments are not adequate. For cases when taking both types of medications is deemed necessary, doctors are urged to limit the dosages and duration of each drug to the minimum possible for the desired effect.

After conducting and reviewing several studies, the FDA has found serious risks in combining central nervous system (CNS) depressants. Namely, a high instance of slowed or difficulty breathing (and even deaths) when opioids and benzodiazepenes are taken together. This warning also applies to patients taking opioid cough medicines and/or opioid pain killers along with alcohol.

For those patients who are taking a combination of opioid and benzodiazepene drugs (or other CNS depressants, including alcohol), you are urged to seek medical attention immediately if you or someone you are caring for experiences unusual lightheadedness or dizziness, slowed or difficult breathing, extreme sleepiness, or becomes unresponsive (such as not answering or reacting normally, or being unable to wake them up).

Opioids are a class of powerful narcotic medicines that are used to treat severe pain. Certain opioids, such as codeine and hydrocodone, are approved in combination with other drugs to reduce coughing. The FDA states that these drugs carry serious risks including misuse and abuse, addiction, overdose, and death. Benzodiazepenes are a class of medicines which are widely used to treat conditions such as anxiety, seizures, and insomnia.

For those of you taking both types of medications, what do you think about these warnings from the FDA? Do you think your doctor will be adjusting your treatment plan as a result? Leave us a message below...


via FDA: Drug Safety Communication

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I have stage 4 kidney cancer w/ mets to bones ,lungs;and pancreas, I,ve been on and off oxycodone and valium for 11 yrs now with no problem. I dont believe it to be a safe combination in the beginning ,however a tolerance to these drugs build up over time I see no problem with the combination when taken as prescribed.

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So let's punish all the people with legitimate needs for both medications. Don't hold the people accountable that's abusing them. Great job government for screwing the people over once again. We are supposed to trust you? At one time coke was good for us remember? Yes that's Sarcasm. My point is why should we trust what you think is good for us at the time!? Start punishing the ones od'ing for taking it incorrectly or that shouldn't be using it at all because they don't have a script! Smh, this world we lived in is so screwed up. Next watch they will outlaw oxycodone. Mark my words they are trying to move towards that next! So if you are in any REAL pain I feel bad for you.

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I feel the same, I've been taking morphine 60mg. er. and Dilaudid 8mg. along with Xanax for several years due to to many health problems to mention, and you build up a tollarnce after taking them long term, I have no negative problems taking these meds.however, you should start at low doses and adjust as necessary as time goes by. I have a good relationship with my doctor, and that's important as well so he feels comfortable prescribing them. There are a lot of people in need of these meds to have somewhat of a quality of life, and the FDA, DEA, are making it more and more difficult to get the meds a lot of people need. Since I've been taking them for several years, I feel I'm kinda grandfathered in. I know to get these meds for someone who is just now having enough health problems to have these meds, doctors and pharmacy's are more reluctant to dispense these. I was at my pharmacy a couple months ago filling my Dilaudid when a new person came in with a Dilaudid script, the pharmacist told him he didn't have them, he said he's been all over town, then he gave me mine, rang it up and said "see you next month.
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I think yes people need to be careful but at the same time it's just going to make it way more difficult for the people, including myself, who LEGITAMATELY need those meds to get them! Also, I DO NOT think it's fair that the people who have been taking the meds for a long time for whatever health reasons are able to get them way easier than say someone who was just recently diagnosed with the same illness/pain issues as the people who were diagnosed and given the meds a long time ago! The only real difference is the timing of it all!!! And as for whoever said they "feel like they've been grandfathered in into getting the meds", I think that's bullsh*t cuz like I said, the ONLY REAL DIFFERENCE IS THE TIMING OF PEOPLE GETTING DIAGNOSED/INJURED TO WHERE THEY NEED THE MEDS! I SAY SHAME ON THE "ABUSERS" FOR CAUSING THIS WHOLE MESS CUZ NOW I'M SURE MANY PEOPLE!, INCLUDING MYSELF, ARE SUFFERING BCUZ U NEED TO BE DAMN NEAR TERMINAL TO GET ANY MEDS THAT HELP. AND EVEN THEN I'VE SEEN & KNOWN TERMINALLY ILL PEOPLE BE DENIED MEDS CUZ OF THIS BS!!!! SO SAD AND SO NOT RIGHT! !!!!!!!!

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I have an enormous battle going on presently after being on tramacet, celebrex and urbanol at the same time for a few years. I took only one of each every day. I have come off all three in the last few months but am now experiencing very severe restless legs and also insomnia to a point of really battling to sleep for longer than a few hours at night. Incidentally I have had restless legs on and off for many years but definitely not like now. Until reading this article of yours I have not been sure of what my problem was. The doctors have decided that I am anxious and need anti-depressants plus sleeping tablets which I am very reluctant to take because of masking symptoms.. I also have an underactive thyroid gland which has become overactive after my doctor increased my daily euthyrox as a result of a blood reading. Do you consider your article today to be relevant to what I am experiencing or is it possibly coincidental. Thank you.

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I've been on opioids for pain, as well as xanax for 15+ years. My Dr knows I take my meds properly and responsibly. I don't think it will affect how my doctor prescribes to me. We all know, if a person is going to abuse any type of drugs they are going to regardless, of what, or how the DEA makes or changes these laws. We already have a problem with chronic pain patients being able to properly receive the necessary medications to live a productive life. I advise all chronic pain patients, to get involved with the U.S. Pain Foundation and sign the petition that's being sent to the White House, to lobby for better treatment for us. Thanks

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Dean, you are so on point. People that plan on abusing medications will do so regardless of any regulations, and I'm sure the FDA must know this. So then it becomes a question of why bother releasing these new warnings? Are we to believe that doctors don't already know the potential interactions and that these new warnings suddenly alert them to this fact? Call me crazy but I wonder if this, along with the CDC's new guidelines from earlier this year, are part of an effort to encourage doctors to look into prescribing alternatives to the traditional narcotic meds? Do we really have a problem with so many legitimate patients handing out their drugs? Just trying to understand the main motivations behind the regulators.

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I have seen death up close and very personal from the combination of oral pain opioids and benzodiazepenes. I have personally gone through hell withdrawing from this combination.

FDA is so far behind on getting this issue under control it is criminal.

I understand that there are important and very needful uses for the combination of a variety of drug classes that would otherwise never be co-administered.

I have also had a 14 year old blow his last ORID breath in my face.

If you are sick, really sick, you know exactly what I mean when I sometimes shout about the value of life. Please speak up. Don't let junkies claiming illness as an excuse shout down the voices arguing for the safe, sane and non-addictive use of powerful drugs that teenagers need not experiment with. My generation dropped acid like as a party drug. Today's kids are dropping oxy's. Please people, think about it.

Sorry for the emotion. I am not over my experiences yet.

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Mark are you aware that less than 1% is allotted, to study effects of opioids, on chronic, legitimate pain patients? How sad. We already have enough suicides, of chronic pain patients, due to the fact of not receiving proper treatment with the medications they need, just to live a halfway normal life. People who have never experienced, or live daily, 24/7 with chronic pain have NO CLUE what it is like.

I ask does anyone want to live a life of existing, not living? Facts are so many are existing this way. Dr's are not stupid. They can tell who is a drug seeker and who is a legitimate chronic pain patient? In the state, in which I live it has become nearly impossible for druggies to receive these meds legally. The pain management that I see is very strict!!! I can assure you that he does NOT prescribe, unless you meet a very strict criteria, for reasons to be prescribed these types of meds. I just stopped 1 year of IV Infusions @28 days, of DMDT, for Multiple Sclerosis. They had to be stopped, due to a horrible flare, of a crippling RA I've been battling for 22+ years. The DEA, FDA are trying to lump us Chronic pain patients, in the same category as addicts!!! This has to stop!!! I would ask them this question. If you have a child suffering horribly, constantly, non stop, with debilitating, disabling, crippling pain, would you watch them suffer and deny them the proper medication, the ONLY medication/treatment, that would help them??"

We MUST get involved, if we want to keep our rights, for the proper meds and treatment!! Please, please get involved with the US Pain Foundation, who are fighting for our rights!!! We MUST come out in numbers and stick together, if we hope to change these things. Would a diabetic be denied the insulin their body needs to keep them healthy and alive? Would a cancer patient be denied their chemotherapy, or radiation to save their life? We chronic pain patients deserve the same rights, to our pain meds, to do the same. Thanks and have a great day!

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I wrote about my problem the day before yesterday but now need some positive help towards resolving it. To reiterate I was on opioids and benzodiazepenes for about three years before stopping. These were given to me under prescription. I was concerned about long term consequences so questioned an independent doctor about this approximately one and a half years ago. When I said I was 76 years old he passed it off as if to say I was old now so it didn't really matter. Then suddenly last year I started falling asleep early in the day, wanting to sleep when I was driving etc etc. This was when I decided to wean myself off all these tablets and now am going through an indescribable trial.. I cant sleep because of extremely severe restless legs. The only thing that helps is taking a certain tablet at night but I am very reluctant to do so. HELP!!! Can anyone suggest what I can do as I have reached saturation point and am desperate. Please!!!!

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MedsChat Admin, nothing states a doctor can't prescribe certain meds. Doctor do need to be careful when prescribing all their meds. It is still up to each individual doctor to prescribe what they believe is best for their patients.

I do expect many doctors to blame the way they change their prescribing on the CDC, FDA, etc instead of telling their patients in their medical opinion they believe a certain way was not in the patients best interest.

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Yes, that is correct BL - doctors can still prescribe both types of medications at the same time at their discretion. There will just be more warnings associated with that per the FDA. The question is to what extent individual doctors will follow the newest guidelines and how it could affect their treatment plans.

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MedsChat Admin, it will vary depending on the doctor and the patient. I have also found that where you live and the number of overdose deaths have an impact. In the coming months, I am sure you will see more and more posts at MedsChat on this topic when doctors change the way they have been prescribing. Insurance denials when both are prescribed may also increase.

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I've been on both for 20+ years and no problems. The only problem I have is the government shoving it's nose up my ass on my medical care. The way I see it me and my Doctor are the only ones who should know anything about my health. This has went on to long and needs to stop now!

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AGREED, this is well put! I totally agree. I believe when taken under the care of a Dr that actually does his or her job it's perfectly fine! They have a motive behind what theyou are doing. Question is what?!

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That same old s***. Control and money! I'm thinking about canceling both Medicare and my supplement and treating my self. Can't be any worse. What happened with the legal suit they were trying to get started?

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This is such total bs, along with the arbitrary opioid limits. Just because some poor soul with an addiction problem could od based on these guidelines. It is the job of the cdc and doctors to educate this population that needs Help, not the other poor souls living with chronic intractable and suicidal pain that is left out in the dark!

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WendyShawe you stated that last year you suddenly started falling asleep while driving. Don't you think that possibly thia could be caused by something else, medical condition, etc.and not the combination of meds, since you had already been on them for years? I say this because I have experienced the same at times, but when seeking medical attention, by 2 of my Specialists the falling asleep (for me) is caused by another medical condition, not the combination of meds I've safely taken for years.

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I appreciate your response Dean. I actually considered that possibility but now that I am no longer on the meds, the reverse is happening in that I am suffering terribly with a severe restless leg syndrome which is causing insomnia. I am really battling to sleep. As you say and you could be right about your opinion, possibly it is from something entirely different e.g a thyroid problem going from hypo to hyper as a result of an adjustment in the meds I have taken for that particular condition for years. This is being investigated at the moment. All extremely confusing. My feet underneath are red and blotchy with patches of blueness. Its not circulatory which has been confirmed by two independent doc tors. I also have enlarged varicose veins which the doctors say could be the cause of the problem on my feet.

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Same here, Joe. I've been on both for 25 years. Not pushing any daisies yet! I wish I could afford treatment in another country, that actually puts the patient first, but for now I'll just keep fighting best I can for inferior treatment! I wish you and all other CPP all the best. Jobe

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I really do feel sorry for people in the USA regarding their medical care. Here in the UK I get free treatment and all my prescriptions paid for by the government. I am on Opioids and Benzodiazepines, plus numerous Pain Relief medications all for no cost....

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