Throughout 2016, the FDA announced requirements for manufacturers to create new product labeling information for a variety of opioid medications.
A wide range of products, across virtually all opioids, have some form of new labeling information. Below are highlights from the new requirements:
- A new boxed warning for immediate-release (IR) opioids about the serious risks of misuse and abuse, which can lead to addiction, overdose, and death (announced March 22, 2016). The updated labeling clarifies that because of these risks, IR opioids should be reserved for pain severe enough to require opioid treatment and for which alternative treatment options (e.g., nonopioid analgesics or opioid combination products, as appropriate) are inadequate or not tolerated. The dosing information also provides clearer instructions regarding patient monitoring and drug administration, including initial dosage, dosage changes during therapy, and a warning not to abruptly stop treatment in a physically-dependent patient. This action also included several additional changes across all prescription opioid products also addressing the risk of these medications.
- Safety labeling changes for methadone and buprenorphine products when used by pregnant women for medication-assisted treatment (MAT) of opioid use disorder (announced May 26, 2016). This new labeling addresses a key concern over neonatal opioid withdrawal syndrome (NOWS), which can be effectively managed, but may be life-threatening if not recognized and treated. Our action requiring safety labeling changes for MAT-only methadone and buprenorphine products informs prescribers about the risks for NOWS without inadvertently discouraging treatment for pregnant women with opioid addiction.
- Class-wide changes to drug labeling that include information about the serious risks associated with the combined use of certain opioid medications and benzodiazepines (announced August 31, 2016). This includes boxed warnings and requirements for patients to receive Medication Guides when they get their prescriptions. Serious risks from combined use include extreme sleepiness, respiratory depression, coma, and death. Among other important information, these labeling changes encourage prescribers to use the lowest effective dose over the shortest duration of time necessary if analgesic opioids and benzodiazepines must be used concurrently. Additionally, the labeling says that opioid cough syrups should never be used simultaneously with benzodiazepines.
When the FDA requires new product labeling, manufacturers are given time to meet the requirements and submit the new labeling information to the FDA for approval. For regulatory efficiency and for a smoother transition of information for stakeholders, including prescribers, the FDA arranged to have all of these separately required changes to be effective on the same date.
The updated labels are an important part of the FDA’s continuing effort to educate patients and prescribers about the risks related to prescription opioids, including the importance of balancing the benefits and risks for each individual patient and emphasizing information important for appropriate patient selection.
Sharon Hertz, MD, is the Director, Division of Anesthesia, Analgesia, and Addiction Products (DAAAP), Office of New Drugs, Center for Drug Evaluation and Research, at the US Food and Drug Administration.