By Frank Lewis
September 12, 2013
PDT Staff Writer
At one point in time, over the last several years, Scioto County was arguably the epicenter of the prescription drug abuse problem plaguing the nation, and while many strides were made including the shutting down of all nine pain clinics in town, some issues surrounding the prescribing and the selling on the streets of those medications continue. Several anti drug abuse activists in the region have been involved in efforts to change the labeling of such drugs. Now, U.S. Representative Harold “Hal” Rogers (KY-05) is applauding 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. Tuesday’s announcement by the FDA will help ensure that these drugs are only prescribed for patients suffering from chronic, long-term pain.
FDA Commissioner Margaret Hamburg, M.D., said the agency invoked its authority to require safer labels “to combat the crisis of misuse, abuse, addiction, overdose, and death from these potent drugs that have harmed too many patients and devastated too many families.”
“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.”
The 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.
“I am happy to see that the FDA has finally taken some definitive action because it is way overdue,” Lisa Roberts RN, one of those on the front lines locally, said. “The Petition that was circulated by the Physicians for Responsible Opioid Prescribing basically held the FDA’s feet to the fire, and many of us in Scioto County signed that petition. The FDA partially responded to the requests of that Petition by invoking their authority to initiate these label changes, and striking ‘moderate to severe pain’ from the indication for ER/LA opioid analgesics, but they excluded other opioid pain medication such as immediate release opioids.
Roberts said the Petition was for all opioid pain medications.
“So this action does leave the door open for drug manufacturers to continue promoting high-dose, long-term opioid treatment for common chronic conditions where the risks are likely to outweigh the benefits,” Roberts said. “And by making these manufacturers in charge of their own research studies-well that is sort of a fox in the henhouse situation. I would not necessarily trust them to be impartial. We are talking about billions of dollars in profit here for these drug manufacturers”.
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.
The FDA is also 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.
Frank Lewis may be reached at 740-353-3101, ext. 252, or at firstname.lastname@example.org. For breaking news, follow Frank on Twitter @FrankLewisPDT.