Combining opioid pain or cough medicines with benzodiazepines may cause serious risks and death

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Combining opioid pain or cough medicines with benzodiazepines may cause serious risks and death

Opioids are a class of powerful narcotic medicines that are used to treat pain and cough.They also have serious risks including misuse and abuse, addiction, overdose, and death. Opioids such as codeine and hydrocodone are also approved in combination with other medicines to reduce coughing. Benzodiazepines are used to treat anxiety, insomnia, and seizures. FDA review has found that the growing combined use of opioid medicines with benzodiazepines or other drugs that depress the central nervous system (CNS) has resulted in serious side effects, including slowed or difficult breathing and deaths.

FDA conducted two studies that showed an increasing trend in concomitant dispensing of opioid analgesics and benzodiazepines, and an increasing frequency of combined benzodiazepine and prescription opioid misuse, abuse, and overdose, as measured by national emergency department (ED) visit and overdose death rates.The first study examined concomitant use patterns of opioid analgesics and benzodiazepines. Between 2002 and 2014, the annual number of patients dispensed an opioid analgesic increased 8 percent, from 75 million to 81 million, and the annual number of patients dispensed a benzodiazepine increased 31 percent, from 23 million to 30 million. During this period, the proportion of opioid analgesic recipients receiving an overlapping benzodiazepine prescription increased by 41 percent, which translates to an increase of more than 2.5 million opioid analgesic users receiving concomitant benzodiazepines in 2014, compared to 2002. The subgroups with the highest probability of receiving concomitant prescriptions were women, patients older than 65, and chronic users of opioid analgesics. Two additional studies published in the medical literature show more direct evidence of increased risk of adverse events occurring in patients dispensed both opioid analgesics and benzodiazepines.

Recent studies in the literature show that concomitant use of opioid analgesics and CNS depressants other than benzodiazepines, including alcohol, is also associated with serious adverse events. One study reported that opioid analgesics contributed to 77 percent of deaths; where benzodiazepines were determined to be a cause of death, and benzodiazepines contributed to 30 percent of deaths where opioid analgesics were determined to be a cause of death. This study also analyzed the involvement of other CNS depressants (including barbiturates, antipsychotic and neuroleptic drugs, antiepileptic and antiparkinsonian drugs, anesthetics, autonomic nervous system drugs, and muscle relaxants) in these deaths and found that these CNS depressants were contributory to death in many cases where opioid analgesics were also implicated.

Additional information for patients

·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 bemisused 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 health care professional if you have any questions or concerns about opioids, benzodiazepines, or other medicines you are taking.

·Report side effects from opioids, benzodiazepines, or other medicines

Additional information to health care professionals

·      Concomitant use of opioid pain or cough medicines and benzodiazepines, other central nervous system (CNS) depressants, or alcohol may result in profound sedation, respiratory depression, coma, and/or death.

·      Reserve concomitant prescribing of opioid analgesics with benzodiazepines or other CNS depressants for use in patients for whom alternative treatment options are inadequate.

·      Avoid use of prescription opioid cough medications in patients on benzodiazepines or other CNS depressants.

·      If the decision is made to concomitantly prescribe a benzodiazepine or other CNS depressant for an indication other than epilepsy with an opioid analgesic, prescribe a lower initial dose of the benzodiazepine or other CNS depressant than indicated in the absence of an opioid, and titrate based on clinical response.

·      If an opioid analgesic is initiated in a patient already taking a benzodiazepine or other CNS depressant, prescribe a lower initial dose of the opioid, and titrate based on clinical response.

·      Monitor patients closely for respiratory depression and sedation.

·      Advise both patients and caregivers about the risks of respiratory depression and sedation if opioids are used with benzodiazepines, alcohol, or other CNS depressants (including illicit or recreational drugs).

·      Advise patients not to drive or operate heavy machinery until the effects of concomitant use of the opioid and benzodiazepine or other CNS depressant have been determined.

·      Screen patients for risk of substance-use disorders, including opioid abuse and misuse, and warn them of the risk for overdose and death associated with the use of additional CNS depressants, including alcohol and illicit or recreational drugs.

·      Report adverse events involving opioids, benzodiazepines, or other medicines