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FDA Decision Agrees with Attorney General Morrisey and 42 Other States to Add Better Warnings on Opid Prescriptions
“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,” Attorney General Morrisey said. “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-threating conditions in their unborn child. This is an area that other state attorneys general and I have been particularly concerned about.”
In May, Attorney General 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.
In its Sept. 10 release, 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.” The FDA said symptoms of NOWS may include poor feeding, rapid breathing, trembling, and excessive or high-pitched crying.
In addition, the FDA said because long-lasting and extended-release opioid-based analgesics carry a risk of addiction, abuse, misuse, overdose or death, physicians should only prescribe them to patients with “around-the-clock” pain for whom alternative options are either ineffective, not tolerated, or are ineffective. The FDA 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.”