The Food and Drug Administration (FDA) notes that an epidemic of addiction and overdose deaths from prescription painkillers is ongoing in the US. The agency is attacking this issue on several fronts. One is the September 10 announcement that major changes in labeling requirements for opioids. Opioids are strong narcotics that come from the same drug family as morphine and heroin; they have a high risk of addiction.
The FDA notes that consumers and healthcare professionals will soon find updated labeling for extended-release and long-acting opioid pain relievers to help ensure their safe and appropriate use. In addition to requiring new labeling on these prescription medications, the agency is also requiring manufacturers to study certain known serious risks when these drugs are used long-term. The FDA notes that long-acting forms of opioid pain killers, such as OxyContin, should be used only when there is no alternative. Until now, the agency had said the drugs were appropriate for the treatment of “moderate-to-severe” pain. The new drug label drops the word “moderate” and says it should be used only to manage “pain severe enough to require daily, around-the clock, long-term treatment.” The drugs will also contain a new boxed warning that cautions about using the drugs while pregnant. U.S. hospitals have seen a surge in newborns dependent on the drugs, according to a study in the Journal of the American Medical Association.
“The new labeling requirements and other actions are intended to help prescribers and patients make better decisions about who benefits from the use of these medications. They also are meant to reduce problems associated with their use,” noted Douglas Throckmorton, M.D., deputy director of regulatory programs in FDA’s Center for Drug Evaluation and Research. He added, “Altogether, the actions we’re now announcing are part of FDA’s efforts to make opioids as safe as possible for those who need them.” He explained that the actions come after careful analysis of new safety information, including reviews of medical literature, and consideration of input from patients, experts and many other interested parties.
Opioids work by changing the way the brain perceives pain. They are available by prescription as pills, liquids, and skin patches. Extended-release and long-acting (ER/LA) forms pose a greater safety concern because—as their names suggest—they produce their effects for a longer period, and many contain higher doses compared with immediate release or opioid/non-opioid combination products. They include, to name a few, long acting versions of opioids such as morphine, oxycodone, and fentanyl. ER/Las contain a much larger load of the drug, designed to trickle into the bloodstream over several hours. Drug abusers have learned to break the time-release mechanism by crushing, snorting or injecting the pills to get all the drug at once for a heroin-like high.
The “limitations of use” portion of the new labeling retains language indicating that the drugs are not intended for use as an “as-needed” pain reliever. Furthermore, the new labeling adds: “Because of the risks of addiction, abuse and misuse with opioids, even at recommended doses, and because of the greater risks of overdose and death with extended-release opioid formulations, reserve [Drug Name] for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or immediate-release opioids) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.”
This new labeling language emphasizes that patients in pain should be assessed not only by their rating on a pain intensity scale, but also based on a more thoughtful determination that their pain—however it may be defined—is severe enough to require daily, around-the-clock, long-term opioid treatment, and for which alternative treatment options are inadequate.
This framework better enables prescribers to make decisions based on a patient’s individual needs, given the serious risks associated with ER/LA opioids, against a backdrop of alternatives such as immediate release (IR) opioids and non-opioid pain relievers. It allows prescribers to make an assessment of pain relative to a patient’s ability to perform daily activities or enjoy a reasonable quality of life.
FDA-approved labeling of these pain relievers already describes the effects on newborns of exposure to these drugs while in the mother’s womb and warns against use by women during pregnancy and labor and while nursing. The new labeling, however, will provide more detail and will elevate the risk of neonatal opioid withdrawal syndrome (NOWS) to the most prominent position in labeling—a boxed warning. Symptoms of NOWS may include poor feeding, rapid breathing, trembling, and excessive or high-pitched crying.