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.

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“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’m sick and tired of all the B/S about Ppl who really need pain meds and anxiety meds. Being treated like drug seeker. When the Ppl who are O/Ding
    Are the ones who are taking them wrong or taking to many. All it is doing is making it hard for the people who take them the rt way. Get them!!!!!

  • I’ve been treated for anxiety since I was 19yrs. old. I had panic attacks and swore it was a heart attack. I’d go to the ER and say I was having a heart attack. They checked me out and time and time again I was told it is your nerves! Prescribed things like Ativan, valium, serax, etc. I finally was convinced it was my nerves and have been treated with benzos. Later in my early 30’s I found out the pain in my back and neck was degenerative disc disease. After 2 surgeries at L4 and L5 and facing a fusion there and neck surgery also, I’m on Percocet 10 mg. twice a day and 2mg of klonopin a day for anxiety. I take my meds as prescribed, do not take street drugs and I think under my circumstances its not a bad combo. I have known so many people overdosing but they are getting meds from doctors and buying off the street. Some people are so under the influence in public. I’ve seen many, many people abusing their meds and at least 20 to 30 people shooting whatever they can, combining alcohol, marijuana, cold meds, 8 and 10 Xanax, etc. These people passed out and never woke up and they are making it hard for people like me and a lot of others that don’t abuse their meds. I feel safe about what I take and I honestly don’t fear my respiratory system shutting down, passing out and dying. Yet my doctor that gives me the 2 Percocet a day cut me off and said It was because of the 2mg. of klonopin I get from my psychiatrist. And my psychiatrist cut off my 2mg. klonopin because of the 2 Percocet I get. Now I have neither one and that’s not fair to me. I’m a nervous wreck and in a lot of pain. I have no idea what the hell I’m gonna do. I can pass a drug test anytime and have never failed one. I’m a good patient. I take vitamins and take good care of myself. But lately I’ve been treated like a strung out alley cat. It really sucks and there is nothing you can do when youre getting the ax from the doctor. They will say no, no, no, and that’s it. No discussion!!!!!

    • I totally get it! I don’t suffer with the same issue. We should be able to sign off on medications we are willing to take despite side effects.
      You know, I don’t drink and look at the side effects of drinking and the lives lost because of it. Yet people can have it and as much as they want.
      I just want to be able to take Norco for chronic pain that I have suffered with for 20 yrs.

  • They fail to tell you that most of those overdoses are from people taking illegal prescription medications and that’s why it’s so hard for people that actually need them to get them anymore

  • I should probably also included in my comment-that I don’t just take an anxiety med and a pain pill to deal with my health problems. I take nerve block and anti inflammatory also for pain and see a chiropractor-but even with that said…I am never completely pain free and have already explored surgery as an option because injections in my lower back only worked the FIRST time….after that-what a waste of money! and I also take a replacement hormone because I don’t have a thyroid and a heart pill-because of my heart rate being high all the time-I have developed tachycardia…..and now the dea is making me choose my condition because I can’t be treated for both?? I am LIVID….it isn’t fair!!

    • I WISH I could “check on” to rehab and magically walk out of there pain and anxiety free-but I CANT. I have to live my issues. forever.
      there are days I think dying would be better than the pain I live with-last now for example, I slept maybe 3hrs without being interrupted by the throbbing in my hips…..it’s not fair that the people who abuse their meds are ruining for those of us who need them.
      as I am sitting here getting ready for my drs appt-the madder I get!
      I shouldn’t have to go to a handful of drs to get my mess. I can’t! my insurance won’t pay for it….
      if I was going to die in my sleep-I would have before now! I have been on these meds since 2012! that’s when I was diagnosed with cancer and had my thyroid removed….I am so mad-my anxiety and heart rate are already sky high bcoz of this appt. it’s crap!

    • I meant “check in” to rehab.
      I should not type when i’m mad, clearly because I can’t type…I didn’t even spell my name right

  • I have severe pain from arthritis and osteo arthritis. Most of this was caused by a spinal cord injury C-5,6,7. I also have anxiety, which could be caused by my pain and not being able to do things I use to do. I am taking Hydrocodone 10/325 3 times a day and 1mg Xanax twice a day. My doctor has just recently reduced my Xanax 1mg to once daily per the CDC due to health warnings by using both. I don’t know how the reduction of my Xanax to only once a day is going to work. What should I do if my anxiety gets worse?

  • i have been on xanax and pain meds for a long time i was very ill almost ready to give up and my drs worked together and i get pain meds from a pain dr and anxity from a mental dr i was told i had to chooce one of them cause of the dea so i geuss i get to go mentaly crazy i half to have my pain meds or i dont function iam on ssd and if it was not for my drs working together and giving me both meds i hate to say it but i was so sick i would rather be dead then feel the sickness again thanks to all the pepole that abused there medication now the pepole that dont abuse there meds get to suffer thanks to them

    • i’ve had it with the junkies ruining it for those of us who truly need pain medication and anxiety meds!
      I have degenerative disc disease, sciatica in both hips, and I have major anxiety because I do not have a thyroid-I am in remission from thyroid cancer and my levels have to stay “dome suppressed” because of cells, chance of cancer returning etc-so I am symptomatic with being “hyper thyroid”….this caused me to have heart issues, because of accelerated heart rate-I HAVE to take anxiety medication to SLEEP. I will lay there on my back (the only way I can sleep because of hip/back pain) and stare at the ceiling…..I have taken a combination of anxiety and pain meds for years without abusing them-I don’t drink alcohol…..I cannot function normally without them. because of on going heath issues.
      and now I have to see my dr tomorrow because dea says I can’t any longer be on both meds??
      really???
      I am so over it. I have been taking “random” drug screens for years because of the abusers and never have failed any of drug tests….I just don’t understand why those of us who need these meds have to choose which is worse-pain or anxiety?
      it is not fair.

  • Interesting. 80 million patients received prescriptions for opioid pain meds, 30 million of them were prescribed benzodiazapines. Correct me if I’m wrong, but isn’t that just over a third?
    Now let’s look at the current hysteria about benzos being involved in 30% of opioid overdose deaths. If 30% of patients taking opiates also take benzos, and benzos are involved in 30% of opioid overdose deaths, this would suggest that the risk of overdose is not influenced by the concurrent use of benzodiazapines.
    Why do physicians prescribe the two medications together? Because the combination is proven effective clinically.
    Wait, I forgot. The CDC claims there is no evidence that Opioids are effective for management of chronic pain. Perhaps those 80 million prescriptions constitute evidence? Or does the CDC contend that
    physicians are either stupid, or corrupt, and would prescribe these medications for no legitimate reason?

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