FDA Requires New Opioid Label Warnings Over Risks Of Suddenly Stopping Treatment

Federal regulators have called for new label warnings on opioid drugs about the risks of quitting the addictive pain killers suddenly or too quickly, which can lead to withdrawal, use of illicit drugs, and recurrence of severe pain and other complications.

The FDA issued a drug safety communication on Monday, warning that it has received reports of serious harm occurring when patients who are physically dependent on opioid pain medications quit them too quickly.

The agency is requiring changes to the prescribing information for any opioids intended for use in an outpatient setting, providing information about the sudden discontinuation risks for consumers, and a guide for doctors on how to safely decrease, and eventually discontinue, opioid treatment.

According to the agency, rapidly stopping opioid pain killers can lead to uncontrolled pain and withdrawal symptoms. This can cause patients to seek other opioids, including illegal drugs. The FDA notes that in these cases, patients attempting to alleviate pain using heroin and other substances are not necessarily addicted.

“These may be signs of addiction (or opioid use disorder), but they may also be signs that a patient is physically dependent and has stopped opioid treatment too suddenly,” Dr. Douglas Throckmorton, deputy director of the FDA’s Center for Drug Evaluation and Research, said in a press statement on April 9. “There is an appropriate, evidence-based, safe way to taper opioids that can avoid severe side effects and minimize risks. Critically important, any taper must be tailored to the individual patient’s clinical and personal situation because of the many factors involved.”

Throckmorton noted the FDA has received reports of serious harm, withdrawal symptoms, uncontrolled pain and suicide among patients who were physically dependent on opioids, but not considered addicted.

The FDA is advising health care professionals not to abruptly discontinue opioids in patients who are physically dependent. Instead they should develop a patient-specific plan to taper the dose based on their current dosage, the duration of treatment, the type of pain being treated and other factors.

The agency notes there is no standard opioid tapering schedule suitable for all patients, so individual plans will be needed which should seek to avoid serious withdrawal symptoms, worsening the patient’s pain, and which should seek to avoid psychological distress.

Patients are advised not to suddenly stop taking opioids without first consulting with their health care professional for a plan on slowly decreasing use while continuing to manage pain. The FDA notes that even when the discontinuation is managed, patients may still experience withdrawal symptoms, and they should contact their health care professional if they experience increased pain, changes in mood or thoughts of suicide.

Throckmorton said that the FDA plans to soon put forward new policies to address the ongoing opioid crisis, including evidence-based prescribing guidelines and fixed-quantity packaging for immediate-release formulations.

The opioid crisis claims more and more lives each year, due to accidental and intentional overdoses associated with the powerful and addictive pain medications. In fact, Americans are now more likely to die from an opioid overdose than from a car crash.

A report by the U.S. Centers for Disease Control and Prevention published late last year indicated opioids accounted for nearly 70% of all drug overdose deaths.

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