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Medication Safety Alerts

Opioid Medicines with Benzodiazepines MedWatch

08/31/2016

On August 31, 2016, the United States Food and Drug Administration (FDA) issued a MedWatch to warn that using of opioid medicines with benzodiazepines or other drugs that work on the central nervous system (CNS) can cause serious side effects, including slowed or difficult breathing and deaths.

A list of all approved prescription opioid pain and cough medicines, and benzodiazepines and other CNS depressants is provided here.

The FDA recommends that plan members taking opioids with benzodiazepines, other CNS depressant medicines, or alcohol, and caregivers of these patients, should seek medical attention immediately if they or someone they are caring for experiences symptoms of unusual dizziness or lightheadedness, extreme sleepiness, slowed or difficult breathing, or unresponsiveness. 

The FDA has provided the following information for members:

  • Combining opioid pain or prescription opioid cough medicines with medicines called benzodiazepines, which are used for anxiety, insomnia, and seizures, can result in extreme sleepiness, slowed or difficult breathing, coma, or death. These serious side effects result because both opioids and benzodiazepines impact (depress) the central nervous system (CNS). The CNS controls most of the functions of the brain and body.
  • These serious side effects can also occur when opioids are combined with other medicines that depress the CNS or alcohol (see List of Prescription Opioid Pain and Cough Medicines, and List of Benzodiazepines and Other CNS Depressants).
  • Do not drink alcohol with any of these medicines. Alcohol also depresses the CNS and can increase the risk for these serious and life-threatening side effects.
  • Given the serious side effects that may occur, if you are already taking both opioids and benzodiazepines or other medicines that depress the CNS, talk to your health care professional to see if continued combined use is needed.
  • Do not take opioid pain medicines with benzodiazepines or other medicines that depress the CNS without discussing it with your health care professional. Do not take opioid cough medicines with benzodiazepines or other medicines that depress the CNS.
  • Always inform all your doctors about all the medicines you are taking, including prescription and over-the-counter (OTC) medicines. It is helpful to keep a list of all your current medicines in your wallet or another location where it is easily retrieved. You can fill out and print a copy of My Medicine Record.
  • If you are taking an opioid pain or cough medicine or a benzodiazepine and don’t know if you are also receiving other medicines that may interact, contact your pharmacist or doctor.
  • If you are taking both an opioid pain medicine and a benzodiazepine or other medicine that depresses the CNS, avoid driving or operating heavy machinery until you know how the medicines affect you. 
  • Opioids are powerful medicines that can help manage pain when other treatments and medicines are not able to provide enough pain relief.  However, even when used properly, opioids also carry serious risks, and they can be misused and abused, causing addiction, overdose, and death. Benzodiazepines also carry the risk of dependence.
  • It is important to lock up opioids and benzodiazepines and to dispose of them properly to keep them from being taken accidentally by children or falling into the wrong hands.
  • Talk to your doctor if you have any questions or concerns about opioids, benzodiazepines, or other medicines you are taking.
  • Read the patient Medication Guide or patient information leaflet that comes with your filled prescription(s).
  • Report side effects from opioids, benzodiazepines, or other medicines to the FDA.

CVS Caremark Response: There have been no recalls issued on this product by the manufacturers because of this action. CVS Caremark Mail Service Pharmacy will continue to dispense these products.

If you are currently taking opioid pain medicines with benzodiazepines and have questions, please call your doctor or call the FDA consumer inquiry line toll-free at 1‑888‑INFO‑FDA (1‑888‑463‑6332) or visit www.fda.gov.

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