FDA Approves New Safety Labeling for Opioid Medications

The U.S. Food and Drug Administration (FDA) has approved and implemented updated warning labels for all opioid prescriptions, part of a continuing effort to reduce unsafe opioid use and risk for overdose, as well as to urge healthcare professionals to take a more patient-centered approach when prescribing opioid analgesic products. The updated labels include the following information:

• The risk for overdose increases as the dosage increases for all opioid pain medicines.

• Immediate opioids should not be used for an extended period of time unless a patient’s pain remains severe enough to require them and alternative treatment options continue to be inadequate.

• Many acute pain conditions treated in the outpatient setting require no more than a few days of an opioid pain medicine.

• It is recommended to reserve extended release/long-acting opioid pain medicines for severe and persistent pain that requires an extended treatment period with a daily opioid pain medicine and for which alternative treatment options are inadequate.

The update also includes a new warning about opioid-induced hyperalgesia and how to differentiate between that condition and symptoms of opioid tolerance and withdrawal. Despite these changes, FDA emphasized that pain management requires collaboration between providers and patients.

“While FDA understands the importance of ensuring patients continue to have access to opioid analgesics in their pain management regimens, we believe it is equally important to ensure that patients and prescribers are fully aware of all the benefits and risks of treatment with opioid pain medicines,” said Patrizia Cavazzoni, MD, the director of the Center for Drug Evaluation and Research at the FDA. “Approving these class-wide labeling updates facilitates safer use of these medicines and furthers our goal to reduce the risks of nonmedical use and overdose.”