U.S. Rep. Harold "Hal" Rogers (KY-05) applauds the Food and Drug Administration's (FDA) new class-wide safety labeling changes for prescription painkillers. For more than a decade, Rogers has pushed the FDA to take action to reduce the abuse of these powerful medications. Specifically, Rogers has urged that the indication for opioid narcotics be changed from "moderate-to-severe pain" to "severe pain" only, so that physicians are fully aware of the safety concerns before unnecessarily prescribing highly addictive painkillers to patients. Today's announcement by the FDA will help ensure that these drugs are only prescribed for patients suffering from chronic, long-term pain.
"Step by step, we are paving the way for smarter, life-saving practices for prescription painkillers. For far too long, misguided labels, over-prescription, and misunderstanding about the power of pain pills have led to unnecessary addictions. These practices have resulted in untold societal costs of drug treatment, lost wages and jobs, drug-exposed babies, and thousands of accidental overdose deaths nationwide," said Rogers, co-founder and co-chairman of the Congressional Caucus on Prescription Drug Abuse. "This announcement by the FDA is potentially a game-changer, and I applaud Dr. Hamburg for using her authority to tighten the guidelines for prescribing these powerful drugs. Lives will be saved because of this decision."
FDA Commissioner Margaret Hamburg, M.D. said the agency invoked its authority to require safer labels "to combat the crisis of misue, abuse, addiction, overdose, and death from these potent drugs that have harmed too many patients and devastated too many families."
This decision comes after Rogers and six members of the Congressional Caucus on Prescription Drug Abuse pressed the FDA to take action on safety labeling of opioids in August 2012. In a letter to the FDA, the Caucus noted that the Centers for Disease Control and Prevention (CDC) had reported the amount of painkillers sold was four times larger in 2010 than in 1999. The letter warned the FDA of the correlation between increased sales and the growing number of overdose deaths and substance abuse treatment admissions.
The new labels will include a new boxed warning on neonatal opioid withdrawal syndrome, and new postmarked study requirements for all extended-release and long-acting (ER/LA) opioid analgesics intended to treat pain.
FDA is requiring a new boxed warning on ER/LA opioid analgesics to caution that chronic maternal use of these products during pregnancy can result in neonatal opioid withdrawal syndrome (NOWS), which may be life-threatening and require management according to protocols developed by neonatology experts. NOWS can occur in a newborn exposed to opioid drugs while in the mother’s womb. Symptoms may include poor feeding, rapid breathing, trembling, and excessive or high-pitched crying.
In Kentucky, reports show a 2,400% increase in drug-exposed newborns in a decade. In 2011, 730 babies were reportedly diagnosed with neonatal abstinence syndrome (NAS) compared to only 67 in 2001. Meanwhile, nurseries across the nation reported a 330% increase in NAS from 2000 to 2009, according to the Journal of the American Medical Association. These new FDA labels are designed to raise awareness of newborn dependency as well.
Rogers co-founded the bi-partisan Congressional Caucus on Prescription Drug Abuse to raise awareness of abuse and to work toward innovative and effective policy solutions, incorporating treatment, prevention, law enforcement and research. Rogers has served Kentucky’s 5th Congressional District since 1981. With a focus on economic development, job creation, fighting illegal drugs and preserving Appalachia’s natural treasures, he has a reputation for listening to his constituents and fighting for the region he represents. For more information, visithttp://halrogers.house.gov/ or follow Rogers on Twitter https://twitter.com/#!/RepHalRogers or on Facebookhttps://www.facebook.com/#!/CongressmanHalRogers.