CHARLESTON — State Attorney General Patrick Morrisey said the U.S. Food and Drug Administration is right in its decision to change safety labels on extended-release and long-acting opioid analgesics.
The FDA announced Sept. 10 it will require new labels on the analgesics to warn of the risk of misuse, abuse, overdose or death.
It also is adding a warning about how the medication can impact unborn children and newborns.
“This is an important step for this nation to take in addressing the scourge of prescription drug abuse that is afflicting West Virginia and many other states,” Morrisey said in a statement.
“It is especially nice to see the FDA will include a new boxed warning that says the use of these products by women while pregnant could result in serious, possibly life-threatening conditions in their unborn child. This is an area that other state attorneys general and I have been particularly concerned about.”
In May, Morrisey and attorneys general from 42 other states and territories sent a letter to the FDA asking that it place “black box” warnings on opioid-based pain killers to alert pregnant women that using the medicine during pregnancy could cause significant problems in newborns.
The FDA said the new warning will explain that chronic maternal use of extended-release opioid-based analgesics during pregnancy may “result in neonatal opioid withdrawal syndrome (NOWS), which may be life-threatening and require management according to protocols developed by neonatology experts.”
Symptoms of NOWS may include poor feeding, rapid breathing, trembling, and excessive or high-pitched crying.
In addition, the FDA said physicians should only prescribe the analgesics to patients with “around-the-clock” pain for whom alternative options are either ineffective, not tolerated or are ineffective.
“The FDA’s primary tool for informing prescribers about the approved uses of medications is the product labeling,” said Douglas Throckmorton, M.D., deputy director for regulatory programs in the FDA’s Center for Drug Evaluation and Research.
“These labeling changes describe more clearly the risks and safety concerns associated with ER/LA opioids and will encourage better, more appropriate, prescribing, monitoring and patient counseling practices involving these drugs.”
The FDA said it also will require drug manufacturers to conduct further studies and clinical trials to further assess “the known serious risks of misuse, abuse, increased sensitivity to pain (hyperalgesia), addiction, overdose and death.”
“If West Virginia and other states ever hope to win this battle against prescription pill abuse, we must have help from doctors, pharmacists, drug manufacturers and everyone in the medical community,” Morrisey said.
“There is no silver bullet fix for this problem, but these new safety measures by the FDA definitely are a step in the right direction.”