U.S. Senate Republican Leader Mitch McConnell praised the decision by the Food and Drug Administration today to change the labeling requirements for extended-release and long-acting opiate painkillers. Also for the first time, manufacturers of these drugs will be required to include a boxed warning on neonatal opioid withdrawal syndrome. Kentucky has seen an inundation of babies being born addicted to opiates, and they are filling hospitals around the commonwealth.
“In Kentucky the pain pill epidemic has destroyed thousands of lives and ravaged communities in all 120 counties of our Commonwealth. I continue to hear heartbreaking stories from constituents about individuals who needlessly lost loved ones to opiate drug overdose. The problem is so acute that more Kentuckians die from drug overdose than from car accidents each year,” Senator McConnell said. “Today’s announcement by the FDA is another positive step forward in efforts to fight painkiller abuse in Kentucky. I appreciate FDA Commissioner Margret Hamburg making these changes, which will better inform physicians of the risks of addiction and abuse that this class of drug poses to our communities, and ultimately help to reduce the likelihood of misuse and abuse across Kentucky.”
In addition to the label changes, FDA is requiring post-market studies to gather more information on the safety of chronic opioid use, which they say is currently unclear.
For more information on today’s decision by the FDA click here: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm367726.htm