1 jun 2018 ano - FDA sent safety labeling change notification
letters to drug companies with approved opioid
analgesic products intended for use in an
outpatient setting, which require the companies
to include new safety information regarding the
Opioid Analgesic REMS in the Boxed Warning and
Warnings and Precautions sections of prescribing
information due to a general lack of awareness of
the REMS among all opioid analgesic prescribers.