The US Food and Drug Administration (FDA) says it is requiring two classes of drugs, opioids and benzodiazepines, to bear a boxed warning over serious and sometimes fatal risks when the two drugs are used in combination. Benzodiazepines like Valium and Xanax are prescribed for seizures, insomnia, and anxiety while opioids are used for pain. The warnings will list the dangers of using the medications in tandem, which include extreme sleepiness, respiratory depression, coma and death.
Advertisement
“Nearly one in three unintentional overdose deaths from prescription opioids also involve benzodiazepines”, said Baltimore Health Commissioner Dr. Leana Wen, who worked with the FDA to produce the new warning.
The drug safety agency announced on Wednesday, Aug. 31, that it has ordered almost 400 benzodiazepine products to carry “black box warnings” that inform consumers about the health risks involved in using the drugs with opioid medications. The combination makes an overdose more likely and the warning is aimed at making sure people understand that.
“One thing really stood out to me, that I heard consistently from each place on our trip – benzodiazepines and opioids were an increasing threat for overdose as seen in their emergency departments”, he said. Opioids carry serious risks of misuse, abuse, addiction, overdose, and death.
According to data reviewed by FDA, more than 2.5 million patients were prescribed both an opioid analgesic and benzodiazepine in 2014-a 41% increase since 2002.
Earlier this year, The Centers for Disease Control and Prevention warned doctors that outside of the treatment of cancer there is little reason to prescribe these two classes of medication together and the risks outweigh the rewards.
The CDC estimates that almost 15,000 people in the United States die every year of overdoses involving prescription painkillers. 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. Avoid prescribing prescription opioid cough medicines for patients taking benzodiazepines or other CNS depressants, including alcohol.
BACKGROUND: Opioids are powerful prescription medicines that can help manage pain when other treatments and medicines cannot be taken or are not able to provide enough pain relief.
Advertisement
The new warning requires changes in drug labeling to better inform patients and physicians on the risks associated with taking combinations of the drugs. Could there be a unsafe combination?’ ” she said.
