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 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.

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