News & Press: Patient Safety

Safety Alert: FDA Reports Harm to Patients From Sudden Discontinuation of Opioid Pain Medicine

Tuesday, April 9, 2019  

SIS Patient Safety Alert 04/09/2019: FDA Identifies Harm Reported From Sudden Discontinuation of Opioid Pain Medicines and Requires Label Changes to Guide Prescribers on Gradual, Individualized Tapering

This is an important alert from the Spine Intervention Society. SIS sends Patient Safety Alerts when it receives important information regarding products or services that can impact your patients' safety. When the Food and Drug Administration (FDA) issues a safety alert, or a company announces a recall or market withdrawal, the FDA posts the announcement as a public service. In such cases neither SIS nor the FDA endorse either the product or the company.

The U.S. Food and Drug Administration (FDA) has received reports of serious harm in patients who are physically dependent on opioid pain medicines suddenly having these medicines discontinued or the dose rapidly decreased. These include serious withdrawal symptoms, uncontrolled pain, psychological distress, and suicide.

While the FDA continues to track this safety concern as part of its ongoing monitoring of risks associated with opioid pain medicines, it is requiring changes to the prescribing information for these medicines that are intended for use in the outpatient setting. These changes will provide expanded guidance to health care professionals on how to safely decrease the dose in patients who are physically dependent on opioid pain medicines when the dose is to be decreased or the medicine is to be discontinued.

Rapid discontinuation can result in uncontrolled pain or withdrawal symptoms. 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.

Opioids are a class of powerful prescription medicines that are used to manage pain when other treatments and medicines cannot be taken or are not able to provide enough pain relief. They have serious risks, including abuse, addiction, overdose, and death. Examples of common opioids include codeine, fentanyl, hydrocodone, hydromorphone, morphine, oxycodone, and oxymorphone.

The FDA recommends that health care professionals should not abruptly discontinue opioids in a patient who is physically dependent. The FDA further recommends that when you and your patient have agreed to taper the dose of opioid analgesic, you should consider a variety of factors, 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. The FDA finds that no standard opioid tapering schedule exists that is suitable for all patients, and recommends that you 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 FDA recommends that patients taking opioid pain medicines long-term should not suddenly stop taking medicine without first discussing with their health care professional a plan for how to slowly decrease the dose of the opioid and continue to manage pain. The FDA notes that even when an opioid dose is decreased gradually, patients may experience symptoms of withdrawal (See Additional Information for Patients). The FDA recommends that patients contact their health care professional if they experience increased pain, withdrawal symptoms, changes in mood, or thoughts of suicide.

The FDA is continuing to monitor this safety concern and will update the public if they have new information. Because the FDA is constantly monitoring the safety of opioid pain medicines, they  are also including new prescribing information on other side effects including central sleep apnea and drug interactions. The FDA is also updating information on proper storage and disposal of these medicines that is currently available on their Disposal of Unused Medicines webpage.

To help the FDA track safety issues with medicines, the FDA urges patients and health care professionals to report side effects involving opioids or other medicines to the FDA MedWatch program.

Source: Food and Drug Administration - Accessed 04/09/2019

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