The Food and Drug Administration is requiring labeling changes for all opioid analgesics used in the outpatient setting, to provide additional guidance on safe opioid tapering.
The changes will provide more information on how to safely decrease the dose in opioid-dependent patients. However, as the agency noted in a press release, “there is no standard opioid tapering schedule suitable for all patients.” Therefore, the physician and patient must determine together how to gradually reduce the dose to avoid serious withdrawal symptoms; factors such as duration of treatment, type of pain, and the physical and psychological attributes of the patient should all be considered.
Reports of serious harm associated with sudden opioid discontinuation or dose reduction in physically dependent patients prompted the FDA to take action. “There is an appropriate, evidence-based, safe way to taper opioids that can avoid severe side effects and minimize risks,” said Douglas Throckmorton, MD, Deputy Center Director for Regulatory Programs in the FDA’s Center for Drug Evaluation and Research.
In a safety communication, the FDA advised healthcare providers not to abruptly discontinue opioids in patients who are physically dependent. Providers should create a specific care plan for patients that includes gradual tapering of the dose as well as ongoing monitoring and support. The agency recommended tapering by an increment of no more than 10-25% every 2-4 weeks; lower dosage strengths may need to be provided to the patient for effective tapering.
For those experiencing severe withdrawal symptoms, dose adjustments may need to be made. The most common withdrawal symptoms include restlessness, lacrimation, rhinorrhea, yawning, perspiration, chills, and myalgia.
Further efforts to improve opioid prescribing in order to combat the ongoing opioid crisis are being made, according to the FDA. “We’re working with the National Academies of Sciences, Engineering, and Medicine to help advance the development of evidence-based guidelines for appropriate opioid analgesic prescribing for acute pain resulting from specific conditions or procedures,” said Throckmorton. “We’ll also advance policies to require that immediate-release formulations of opioids be made available in fixed-quantity packaging – such as blister packs – that contain doses (e.g., tablets) more typical of what patients may need for common acute pain conditions and procedures.”
In addition to tapering information, the prescribing information for opioid analgesics will include new information on central sleep apnea and drug interaction, as well as proper storage and disposal of opioid medications.
For more information visit FDA.gov.