NCHR Statement about Hydexor at FDA Opioid Advisory Committee Meeting

There is clear evidence that opioid REMS have not worked in the past, and it is not possible to enforce them.  NCHR encourages the committee to encourage the FDA to not approve an opioid that has not even been studied for efficacy compared to non-opioid pain meds, given the unproven ability to enforce REMS compliance.

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FDA Updates Black Box Warning for Benzodiazepines

The FDA announced that they are updating the “black box warning” for benzodiazepines. FDA will require Medication Guides and prescribing information for benzodiazepines to warn about the risks of physical dependence, withdrawal reactions, misuse, abuse, and addiction.

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