FDA Announces Labeling Changes for Immediate-Release Opioids


From DCAT Value Chain Insights (VCI)

By Regulatory News posted 03-29-2016 14:48

  

In a continuing effort to educate prescribers and patients about the potential risks related to opioid use, the US Food and Drug Administration has announced required class-wide safety labeling changes for immediate-release (IR) opioid pain medications. Among the changes, the FDA is requiring a new boxed warning about the serious risks of misuse, abuse, addiction, overdose, and death. The actions are among a number of steps the agency recently outlined in a plan to reassess its approach to opioid medications. The plan is focused on policies aimed at reversing the epidemic while still providing patients in pain access to effective relief.

The FDA is also requiring several additional safety labeling changes across all prescription opioid products to include additional information on the risk of these medications. This is part of the agency’s overall effort to help inform prescribers about the importance of balancing the serious risks of opioids with their role in managing pain.

The updated indication clarifies that because of risks, IR opioids should be reserved for pain severe enough to require opioid treatment and for which alternative treatment options (e.g., non-opioid 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.

As part of the boxed warning on IR opioid analgesics, the FDA now requires a precaution that chronic maternal use of opioids during pregnancy can result in neonatal opioid withdrawal syndrome (NOWS), which may be life-threatening if not recognized and treated using protocols developed by neonatology experts. NOWS may occur in a newborn exposed to opioid drugs for a prolonged period while in utero.

In 2013, the FDA required class-wide labeling changes for ER/LA opioid analgesics that included modifications to the products’ indications, limitations of use, and warnings, including boxed warnings to more effectively communicate to prescribers the serious risks associated with these drugs. The FDA is now requiring similar changes to the labeling of IR opioid analgesics.

Additionally, the FDA is requiring updated labeling for all opioids (both extended-release/long acting (ER/LA) and IR products) to include safety information about potentially harmful drug interactions with other medicines that can result in a serious central nervous system condition called serotonin syndrome. Updated labeling will also include information about opioid effects on the endocrine system, including a rare but serious disorder of the adrenal glands (called adrenal insufficiency) and decreased sex hormone levels (androgen deficiency). These labeling changes will also make it clear that these negative outcomes can occur whether a patient is taking an opioid to treat pain or if the product is being used for medication-assisted treatments. The FDA issued a Drug Safety Communication outlining these risks.

The FDA is also aware of, and is reviewing, available scientific information about potentially serious outcomes related to interactions between benzodiazepines and opioids. Once a review of all available scientific information is completed, the FDA said it will take necessary actions to ensure prescribers and the public are informed of the risks involved with the use of these medications.

Source: US Food and Drug Administration

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