(HealthDay News) — Because of the danger of “serious harm” to patients, the US Food and Drug Administration is advising doctors not to suddenly stop patients from taking opioid painkillers, or drastically lower the dose.
In a statement released Tuesday, the agency said it is adding a warning about sudden discontinuation of use to the prescribing information of opioid painkillers such as OxyContin (oxycodone), Vicodin (hydrocodone), morphine, and other drugs.
“Rapid discontinuation can result in uncontrolled pain or withdrawal symptoms,” the agency explained. “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.”
The new guideline is meant to help doctors allow patients who no longer require an opioid to safely wean themselves off the drug — cutting their risk for withdrawal symptoms. Instead of cutting a patient off from their prescription opioid, physicians 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,” the agency advised.
Statement by Douglas Throckmorton, M.D., Deputy Center Director for Regulatory Programs in FDA’s Center for Drug Evaluation and Research, on new opioid analgesic labeling changes to give providers better information for how to properly taper patients who are physically dependent on opioids [press release]. FDA; April 9, 2019.