The Food and Drug Administration (FDA) issued a safety announcement Tuesday warning doctors and other healthcare professionals not to suddenly cut opioid pain medications for patients who are physically dependent on the drugs.
The FDA said it has received reports of “serious harm” in patients when medications are discontinued or the dose rapidly decreased, including serious withdrawal symptoms, uncontrolled pain, psychological distress, and suicide.
The FDA’s announcement comes at the same time the Centers for Disease Control and Prevention (CDC) clarified its controversial federal guideline for prescribing opioids, which it issued three years ago in the face of the opioid epidemic sweeping the country. The CDC made clear the guideline was not intended to deny chronic pain patients relief from opioids and encouraged physicians to use their “clinical judgment” in prescribing the medications.
Doctors and other healthcare experts have worried that efforts to curb opioid prescriptions have been detrimental to pain patients, even driving some chronic pain patients to suicide when medications have been cut off or reduced too quickly.
In a statement, the FDA said it is requiring changes to the prescribing information for all opioid analgesic medicines used in outpatient settings and has issued a drug safety communication (PDF) for healthcare providers and patients.
“This information is intended to be used when the healthcare provider and the patient have determined together that a decrease in dose or discontinuation of the opioid is appropriate,” said Douglas Throckmorton, M.D., deputy center director for regulatory programs in the FDA’s Center for Drug Evaluation and Research.
Doctors should consider a variety of factors in tapering opioids, including the dose of the drug, the duration of treatment, the type of pain being treated, and the physical and psychological attributes of the patient, he said.
“There is no standard opioid tapering schedule suitable for all patients,” he said, adding it is up to healthcare providers and patients to agree on how to gradually reduce the dose to avoid withdrawal symptoms, worsening of pain and psychological distress. Doctors should monitor patients closely when tapering opioids.
Today, FDA announced required changes to prescribing information for all opioid analgesics; changes will provide expanded information to health care providers on how to safely decrease the dose in patients who are physically dependent on opioids. https://t.co/qAOQb9M2dz pic.twitter.com/cbaHdw9SFs— Jennifer Rodriguez (@FDASpox) April 9, 2019
The American Medical Association, the country’s largest physician organization, said with overdoses and deaths from opioids continuing in communities across the country, it supports the FDA’s changes to prescription opioid labels to include tapering guidance.
“This patient-centric approach will encourage discussions between patients and physicians on whether a decrease in dose or discontinuation of the opioid is the best approach,” said Barbara L. McAneny, M.D. AMA president, in a statement. “If so, the patient and physicians should discuss how to safely decrease dosages.”