New labeling requirements for extended-release and long-acting opioids

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135524151As we have discussed previously, deaths from drug overdoses, particularly opioids, are on the rise. In an effort to ensure safe use of these extended-release and long-acting narcotic pain relievers, the FDA is mandating new labeling requirements for these medications, as well as requiring the modification of the educational materials accompanying them. These changes are a result of analyzing safety information, new medical literature and input from patients and experts. Extended-release and long-acting (ER/LA) opioids may pose greater safety risks than immediate-release opioids due to the fact that they come in higher doses so their effects may be prolonged as compared to the shorter-acting versions. The duration of these effects may not be known to some patients more used to the shorter-acting preparations, which can lead to serious adverse reactions.

Currently, labels on these medications say they are to be used for the relief of moderate to severe pain in patients requiring continuous, around-the-clock opioid treatment for an extended period of time. An addition to this warning will indicate that this form should only be used after other treatments have been considered. In the limitations of use section of the label, a similar addendum will be made. These two additions encourage (if not mandate) prescribers to assess a patient s individual needs before choosing to use these medications. The risk of neonatal opioid withdrawal syndrome (NOWS) to newborns will now occupy the most prominent position in labeling, - and will be described in more detail. Finally, educational materials will be edited to take into account the new labels.

Dr. Douglas Throckmorton, deputy director of regulatory programs in the FDA s Center for Drug Evaluation and Research says, This is not the first or last initiative, and we will continue supporting broader efforts to solve the serious public health problems associated with the misuse and abuse of opioids.

ACSH s Dr. Gilbert Ross had this to say: The increasing problem of opioid abuse and its ramifications, especially overdose, is garnering more attention from state and federal authorities, both professional and regulatory. The problem is balancing the appropriate prescribing of potent painkillers for patients with chronic painful conditions vs. the likelihood of giving medications of abuse to addicts gaming the system. Too much stringency leads to needless pain, while overly lax oversight increases abuse. Right now, the pendulum has swung towards tighter enforcement we hope the balance achieved will not cause too much suffering while preventing overdose deaths.