enews 4-1-2016

14-month old dies after dental visit
National news media reports this morning the death of a 14-month old Austin,
Texas, girl following a routine dental visit.  According to the 40-year pediatric
dental clinic spokesperson in an interview with the media, anesthesia had been
administered by an anesthesiologist.  The state medical examiner has yet to
report the cause of death.
New warnings and guidelines for opioids
The FDA announced last week it will now require stronger warnings for immediate-
release opioid analgesics.  The “black box” warnings will emphasize that these
medications are a last resort for severe pain when alternatives are ineffective or
can’t be tolerated by the patient.
The label will also highlight the risk of Neonatal Opioid Withdrawal Syndrome if
prescribed to pregnant women.  The label’s dosing information will instruct
prescribers how to administer the drug and monitor patients including a warning
not to “abruptly stop treatment in a physically dependent patient.”
In other action, the FDA announced guidelines to encourage the development
generic, abuse-deterrent formulations of opioids. These generics will face more
testing than other generics to prove the abuse deterrence is the same as the
brand-name drug.  Currently, there are no generic, abuse deterrent opioids on
the market and the brand-name ones represent only 10% of the market.
Related news…
The CDC has new guidelines for prescribing opioids. The guidelines offer three
recommendations:
(1) use non-drug and non-opioid therapies first;
(2) prescribe the lowest effective dosage; and
(3) closely monitor all patients.
The CDC’s recommendations target the overprescribing of opioids, which the
CDC cites as “key driver of America’s drug-overdose epidemic.”  The CDC
points out that sales of opioid prescriptions quadrupled from 1999 to 2014
even though the rate of chronic pain in the U. S. has been stable during that
period.