FDA Proposes Label Changes, Other Controls on ER/LA Opioids

Agency's Actions Serve as Reminder to Prescribe Judiciously, Says FP Expert

September 11, 2013 10:30 am Matt Brown

The FDA is proposing further steps to combat the misuse and abuse of extended-release and long-acting (ER/LA) opioids(www.fda.gov). Those steps are mandating class-wide label changes -- including a new boxed warning for pregnant women -- and imposing a research directive on manufacturers of the drugs.

Douglas Throckmorton, M.D., deputy director of regulatory programs in the FDA's Center for Drug Evaluation and Research, told AAFP News Now that the labeling changes will help ER/LA opioid prescribers tailor their prescribing decisions to a patient's individual needs. He said the drugs should be prescribed only to manage pain severe enough to require daily, around-the-clock, long-term treatment and are not indicated for as-needed pain relief.

"We are attempting to fundamentally change the use of these products from an arbitrary scale -- treating pain -- to a discussion about what 'pain' means to each patient in his or her everyday life," Throckmorton said. "Does this patient really need opioids to relieve his or her pain, or will other modalities work? These drugs are important, but by encouraging doctors to talk with their patients, we hope physicians can be more careful and targeted in their prescribing patterns and we can preserve access for the appropriate patients."

Story highlights
  • The FDA has proposed mandating class-wide label changes to extended-release and long-acting (ER/LA) opioids, including a new boxed warning for pregnant women, as well as imposing a postmarketing research directive on manufacturers of these drugs.
  • The FDA says ER/LA opioids should be prescribed only to manage pain severe enough to require daily, around-the-clock, long-term treatment and are not indicated for as-needed pain relief.
  • Chronic maternal use of ER/LA opioids during pregnancy can result in neonatal opioid withdrawal syndrome.

According to a Sept. 10 news release(www.fda.gov), the FDA also is sending letters(www.fda.gov) to manufacturers of ER/LA opioids requiring them to conduct postmarketing studies and clinical trials "to further assess the known serious risks of misuse, abuse, hyperalgesia, addiction, overdose and death associated with the long-term use of ER/LA opioid analgesics."

Throckmorton said the motivation behind the postmarketing research requirement is simple. "It is evident that, when it comes to these drugs, we don't know what we need to know," he said. "Once these studies are done, we will be able to ask questions to determine if, for example, there's a dose threshold over which we should be concerned or possibly a duration concern. With that information, we'll be able to make further labeling changes that will help prescribers."

The new boxed warning cautions that chronic maternal use of ER/LA opioids during pregnancy can result in neonatal opioid withdrawal syndrome, which can be life-threatening. Symptoms include poor feeding, rapid breathing, trembling, and excessive or high-pitched crying.

"Babies exposed to opioids in utero face consequences, but it is also true that there are pregnant women who need opioids to manage their pain," Throckmorton said. "So we are not saying 'never,' but we want doctors to be careful and talk with their patients."

In a recent blog post(blogs.fda.gov), FDA Commissioner Margaret Hamburg, M.D., said the proposed changes put a greater emphasis on the risks ER/LA opioids pose to newborns, but also highlight the importance of physician-patient communication.

"The goal of all of these labeling changes is to help physicians work with their patients to determine whether these potent pain relievers are the most appropriate treatment for their specific situation and, if so, to help them in managing their use," said Hamburg. "While our intent is to encourage safer and more appropriate use of these products, simply changing the labeling won't make an impact if these changes are not understood and integrated into practice by health care providers. So I am urging prescribers to spend some time going over this new labeling, when final, reflecting on what the language means to their practice, and communicating what they've learned to their patients."

Throckmorton said that after the safety labeling changes are finalized, modifications also will be made to the ER/LA Opioid Analgesics Risk Evaluation and Mitigation Strategy to reflect the updated information.

Robert Rich Jr., M.D., of Bladenboro, N.C., chair of the AAFP Commission on Health of the Public and Science's Opioid Abuse and Pain Management Workgroup, said the label changes serve as another warning sign that physicians should exercise caution in prescribing ER/LA opioids, but he added that he did not think the FDA's proposed actions, if implemented, would change much in terms of everyday practice.

"This may help to provide family docs with a better understanding of the risks and benefits of these medications," Rich said. "But I doubt it will change much in terms of prescribing habits, other than that some docs may exercise a little more caution with some of their more borderline or questionable patients. For the routine patients who clearly need these medications, it's just another reminder for us to be cautious."

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