FDA Requires Boxed Warnings to Address Combination Use of Opioids/Benzodiazepines

In making its announcement FDA Commissioner Robert Califf, M.D. stated 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.”  Click here for the full story and click here to begin a conversation with us re your safety surveillance of drug development program.