Opioids and benzodiazepine drugs may result in serious risks when misused. Therefore FDA has recently issued boxed warnings and labeling changes for the safe use of the drug.

‘Opioids and benzodiazepines require strong labeling changes and warnings from FDA to avoid side effects and serious risks.’

After receiving citizen petitions from numerous public and health care officials for concomitant use of opioids and benzodiazepines, the FDA has inititated review for safety informations on the combined use of opioids with benzodiazepines.




FDA requires boxed warnings and medication guides for about 400 opioid and benzodiazepine drugs. These drugs must have their serious side effects and risks mentioned in the warnings which includes sleepiness, respiratory depression, coma and death.
Robert Califf, M.D., FDA commissioner said that, “It is nothing short of a public health crisis when you see a substantial increase of avoidable overdose and death related to two widely used drug classes being taken together,”
“We implore health care professionals to heed these new warnings and more carefully and thoroughly evaluate, on a patient-by-patient basis, whether the benefits of using opioids and benzodiazepines – or CNS depressants more generally – together outweigh these serious risks.” he added.
According to a data reviewed by the FDA from 2004 - 2011, the use of opioids and benzodiazepine drugs without prescriptions has increased over the period and the number of overdose deaths were found to be tripled.
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The warnings must be taken seriously to reduce opioid misuse and abuse and proper care should be initiated for safe use of the drugs.
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Source-Medindia