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.
“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.
I currently take Alprazolam 0.5mg twice a day for anxiety. Have been for a year now. I just had acl/meniscus surgery yesterday and I’m having a hard time handling the pain because I’m so nervous about the interaction. I’ve spaced them out for 4 hours in between, but It’s still a little unsettling. Is that a safe amount of time to wait in between? I’ve asked my pharmacist and she said to wait 3-4 hours. Has anyone else had to deal with this? Any feedback would be great. Thanks!
I have taken 1mg alprazolam with 10/325 Hydrocodone every day for more than 10 years. I take them at the same time, and I have never had ANY side effect, let alone a bad one. These medications have been prescribed together for decades, and millions of people have taken them together. These new “rules” are ridiculous, and are aimed at preventing doctors from prescribing opioid pain medications at the expense of patients suffering.
I see postings from people with the same kinds of problems I have. If you scroll down you will see my previous post. Every month is a fight. I’m in so much pain. What is this site for? How is it going to help us? Is there someone keeping track of our comments that has a plan? How do we stop the madness?
My fiance has ptsd with generalized panic disorder. The only mesication which has controlled her symptoms is zanax. She also has Peripheral Neuropathy, which is crippling without opioid pain management. Her medication is Methadone. Her Dr retired last year, and she has been unable to find a Dr willing to prescribe both, leaving her either a quivering sobbing hysterical mess or bedbound and screaming in pain. Is this not a presentation of multiple diagnosis, which individually would indicate her prescription, legitimate scientifically based reason to prescribe both?
It should be noted she took both for 15 years before her previous Dr retired.
At this time I am ready to check her in for an inpatient evaluation, as her mental and emotional condition is deteriating without proper treatment of her very real symptoms.
Nxt time this author wants to make blanket statements like this about the legitimacy of a medical practice he should consider the entire issue instead of only one aspect.
I have been on both Hydrocodone 10/325 and 2mg of Klonopin for years. I never take them together. I take 4 Hydrocodone for chronic pain due to breaking my back and take Klonopin for Generalized Anxiety Disorder. I also take 200mg of Zoloft. I have never had any problems? I have never abused any of my medications.
I had my first nervous breakdown at the age of 11. Tough time growing up. Have been on anxiety medication all my life. Then 4 years ago I started getting spinal fractures from osteoporosis. I have had 7. I also have RA and lupus. So I suffer with extreme pain daily. I understand there are rules and guidelines. But I have never abused any drug. So because of the law, and they won’t look at each individual case, I have to suffer on a daily basis. Very little quality of life. I personally don’t think I should be punished because I sure did not ask to have mental health. And definitely not osteoporosis. I wish there was a way I could be helped. It’s very depressing!!!
This is completely bias torward the abuser who take these for a buzz. I currently take .5 klonopin once or twice per day and percocet for my severe back pain. I don’t abuse my meds. I have some left over nearly every month. I don’t think I’m addicted but I use it only when needed for my panic attacks and back pain as directed. If you use them as directed you wont die. No different than using anything responsibly. If you use your rear view mirrors while backing out of your driveway you wont run over the kids. Directions and warnings are on the bottle. 2 different drugs to treat different conditions. It’s up to you to follow directions. Don’t prescribe certain things to known abusers. Most deaths occur because the small number of bad doctors and the black market. You can’t just cut off people who really need the meds.
It’s ridiculous!!! I don’t take them together!!! There are meds given ,but u need to wait hours to take them!! It’s wrong I’m 66 yrs old & I’m not stupid !! The heroin junkies are making it bad for everyone!! And know one should tell me what to do with my pain management!!I have pain &I have muscles spasms & anxiety orders!! I don’t take stuff together!!!
Absolutely my friend. You spread the time out. I’ve had 4 back surgeries. Real pain. This anxiety disorder is an unfortunate problem resulting from the years of dealing with the pile on my plate. Low testosterone from years of meds probably doesn’t help it either.
I get the risk, but I have severe chronic pain, terrible muscle spasms and anxiety. Not only is it hard for me to fall asleep but the chronic pain wakes me up after less than a hour. After 2 years of trying pain management, a dozen different drugs (unmanageable side effects), physical therapy, acupuncture, and steroid injections my Neurologist came up with a combination of 5 mg of Oxycodone and 1 mg Clonazapam at bed time so I can get some sleep. I have been taking this combination for 10 years. It has been a life saver but now my primary physician won’t prescribe it. Circumstances required me to change insurance. So I went back to my original Neurologist (which is out of my insurance Network) for prescriptions. I’m so angry. Look at the dose I’m taking. It is so small and it works. I’ve signed all the damn papers saying I’m informed, I had to buy Narcan (?), I have submit to random drug tests. I follow all the rules but every month is a fight to get them filled. My new insurance company keeps wanting me to try drugs and therapy I already tried. The combination at the lowest dose possible works for me. Stop trying to take them away from me.
Within the last year my PCP prescribed a Fentanyl patch 25mcg every 72 hours and Percocet 10/325 x 3 daily for severe chronic low back pain. She KNEW I was taking alprazolam 2mg x 3 daily because I keep a constantly updated medication list along with my health history and all surgeries I have had. Upon a recent regular scheduled visit with my psychiatrist I mentioned these Opioids to him and the look of horror on his face said it all! He immediately decreased my alprazolam to 1mg x 3 daily and told me I could have stopped breathing in my sleep and died. Upon my next visit with my PCP (she does have me see her every three months as long as I’m on the opioids) I mentioned my psychiatrist’s concerns and she didn’t appear to be phased by it! I have now requested to be weaned off the Fentanyl patch safely. My PCP is a good doctor except for this error and I find it extremely unforgivable. I do my part by keeping complete records with me at all times yet doctors continue make errors such as this. I am now more diligent then ever because of high doses of heart medications I must take for the rest of my life because of very serious cad and chf due to bad heart genes I inherited from my dad. My neurologist, without informing me, recently doubled my dosage of gabapentin from 300mg 4x daily to 600mg 4x daily. I currently have stage 3b ckd (my gfr is 32) and I’m concerned about toxicity with that high of a dose also. The hospital I go to has recently transitioned to Northwestern Healthcare and my patient portal is a mess. It has me taking omeprazole on a regular basis which I have not taken in years because it can interfer with the clopidigrel I will be on for the rest of my life. My cardiologist warned me about taking these two together because it can lessen the effect of the clopidigrel and leave me at greater risk for a heart attack or stroke.
I am a 75 year old female, widowed 4 years ago and live by myself and have to be extra diligent about my medications because doctors don’t seem to be doing their job! I will actually call a pharmacist everytime I’m prescribed a new medication and check for any interactions before I’ll take it.
Healthcare is not improving, it appears to be going downhill and doctors need to be better educated. I am actually very lucky to still be here because my psychiatrist caught a very serious error.
Hope you can get off the patch soon. Fentanyl is scary
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