Reports of withdrawal symptoms, uncontrolled pain, psychological distress and suicide in patients who are physically dependent on opioid pain medication who abruptly discontinue or rapidly decrease their dosage has prompted the Food and Drug Administration (FDA) to require that opioid manufacturers update the safety labels to guide prescribers on gradual, individualized tapering.
The label update will be required on opioids that are intended for outpatient use, and will provide more information to health care professionals on how to safety decrease the dosage in patients who are physically dependent on the mediation in situations where the drug needs to be decreased or discontinued.
“Rapid discontinuation can result in uncontrolled pain or withdrawal symptoms,” the FDA said in a Safety Communication. “In turn, these symptoms can lead patients to seek other sources of opioid pain medicines, which may be confused with drug-seeking for abuse. Patients may attempt to treat their pain or withdrawal symptoms with illicit opioids, such as heroin and other substances.”
According to the National Institute on Drug Abuse, 80% of people who use heroin, first misused prescription opioids.
The FDA advised health care professionals not to abruptly discontinue opioids in patients who are physically dependent and instead consider a variety of factors including the dose, the duration of treatment, the type of pain being treated, and the physical and psychological attributes of the patient.
“No standard opioid tapering schedule exists that is suitable for all patients,” the agency cautioned. Thus, doctors should “create a patient-specific plan to gradually taper the dose of the opioid and ensure ongoing monitoring and support, as needed, to avoid serious withdrawal symptoms, worsening of the patient’s pain, or psychological distress.”