Tuesday, September 10, 2013

FDA Announces Labeling Changes, Postmarket-Study Requirements for Opioids Analgesics

Today, the Food and Drug Administration (FDA) mandated safety labeling changes and new postmarket study requirements for all extended-release and long-acting (ER/LA) opioid painkillers. The ruling was prompted by the high incidence of overdose-related deaths and misuse of opioid drugs, which was reportedly used by 2.4 million Americans in 2010, according to government data.

The new class wide-labeling changes for ER/LA opioids will include detailed information to assist clinicians with tailoring medication to patients' individual needs, as well as a boxed warning to caution about drug use during pregnancy, which can result in neonatal opioid withdrawal syndrome. The FDA noted that the medications are intended for patients who exhibit “around-the-clock” pain and have exhausted all other options—such as non-opioid medication and immediate-release opioids—to alleviate pain. In addition, the FDA is requiring all ER/LA opioid manufacturers to conduct clinical trials that will assess the serious risks for misuse, abuse, increased sensitivity to pain, addiction, overdose, and death of these medications.

“The FDA’s primary tool for informing prescribers about the approved uses of medications is the product labeling,” said Douglas Throckmorton, M.D., deputy director for regulatory programs in the FDA’s Center for Drug Evaluation and Research. “Today’s safety labeling changes reflect the FDA’s current understanding of the risks and benefits of these products. The FDA will evaluate the results of the postmarket studies, continue to monitor relevant safety data, and take further safety action, as warranted.”

For more information about FDA regulation regarding opioid analgesics, see the articles  "Caution Urged for Clinicians Who Prescribe Opioids" and "FDA Opioid Abuse Proposal Said to Be Too Weak" in Psychiatric News.

(Image: Courtesy of FDA.gov)


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