Stay of Action on the Implementation of Labeling Changes of Neonatal Opioid Withdrawal Syndrome (NOWS) Extended-Release and Long-Acting Opiod Analgesics.
cder 2013-8425 citizen petition stay of action open neonatal opioid withdrawal syndrome NOWS extended-release long-acting
2014-02-11
FDA-2013-P-1289-0004
05:00:00
https://api.regulations.gov/v4/comments/FDA-2013-P-1289-0004
Anonymous
Anonymous
The American College of Obstetricians and Gynecologists strongly opposes the black box warning on long-acting opioid medications directed toward pregnant women.Women who are pregnant and dependent on opioid medications should not be withdrawn from these medications during pregnancy whether they be prescribed or illegally obtained. Withdrawal from opioids during pregnancy is known to cause extreme fetal distress and fetal death.   Neonatal Abstinence Syndrome, which MAY result following maternal opioid use, is a fully treatable condition without subsequent patho-physiology for the child.  The warning proposed by the FDA concerning infant death has not been substantiated.  Moreover, opioid medications are the safest choice for use by pregnant women who experience moderate to severe pain.  They should not be denied adequate pain relief and untreated maternal pain further stresses the fetus.  Please reconsider this warning.   Thank you.