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FDA Warns Doctors: Suddenly Stopping Opioid Painkillers is Harmful

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Something chronic pain patients have long known––that suddenly discontinuing opioid medication can be harmful and even dangerous––has finally been confirmed by the FDA.

On April 9, 2019, the U.S. Food and Drug Administration (FDA) announced that it had “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.” They noted that the harm included serious opioid withdrawal symptoms, uncontrolled pain, psychological distress, and suicide.

Acting on this information, the FDA is now going to require changes to prescribing information for opioid medications that are intended for use in the outpatient setting. The changes will include expanded guidance for prescribers on how to safely taper patients off of opioids, decreasing the dose gradually and individualizing the plan for each patient.

How the Opioid Epidemic Has Affected Chronic Pain Patients

Hardly a week goes by that we don’t hear something about the opioid epidemic. Legislators on both federal and state levels are tripping over each other to try to enact increasingly tougher laws related to prescribing opioids. Unfortunately, chronic pain patients are being trampled in the government’s rush to try to curb the opioid abuse problem.

Because of increasing scrutiny by the DEA (Drug Enforcement Administration), more and more doctors are running scared. They are either drastically cutting back on the amount of opioid medications they prescribe, or are choosing to refuse to prescribe opioids at all––regardless of the circumstance. I frequently hear from chronic pain patients who have suddenly been told that their opioid prescriptions will no longer be refilled. They’re not offered a plan to gradually taper them off; they’re just told no more, period.

When that happens, patients quickly face serious and painful opioid withdrawal symptoms. According to the FDA,

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.

How the FDA Announcement Helps Chronic Pain Patients

Fortunately, in their announcement under “Additional Information for Health Care Providers,” the FDA gives doctors fairly detailed recommendations for how to go about tapering patients off of opioids. They also stress the fact that every patient is different and the tapering plan should be adapted to fit the needs of the individual.

Since not all doctors may be aware of the new FDA recommendations, if you currently take opioids on a regular basis and have any concerns that you may be cut off, you may want to be prepared. Take a printout of the FDA announcement to your next appointment, or at least have it easily accessible on your phone to show your doctor if it becomes necessary.

The FDA announcement also has recommendations for patients.

Patients taking opioid pain medicines long-term should not suddenly stop taking your medicine without first discussing with your health care professional a plan for how to slowly decrease the dose of the opioid and continue to manage your pain. Even when the opioid dose is decreased gradually, you may experience symptoms of withdrawal (See Additional Information for Patients). Contact your health care professional if you experience increased pain, withdrawal symptoms, changes in your mood, or thoughts of suicide.

Fibromyalgia Treatment Involving Opioids

Although some studies seem to indicate that opioid medication may not be helpful as a fibromyalgia treatment, many patients disagree.

One thing that may have complicated the issue revolves around tramadol––a pain medication that many fibromyalgia patients find very helpful. In the past, there has been some confusion as to whether tramadol should be classified as an opioid. Originally, it was not considered to be an opioid, however, in 2014, the DEA announced that tramadol is now a schedule IV controlled substance.

Interestingly, a 2015 study compared three groups of fibromyalgia patients: one using opioids, one using tramadol and one using neither. While all three groups showed a reduction in pain severity, the opioid group had the least improvement. Notably, the tramadol group showed greater improvements and reported fewer visits to the doctor.

A 2016 article in the journal Future Medicine addresses why tramadol may work better for fibromyalgia than other opioids. “There is no evidence that pure opioids are effective in fibromyalgia but there is some evidence that opioids with additional actions on the norepinephrine-related pain modulatory pathways, such as tramadol, can be clinically useful in some patients.”

Despite what studies may show one way or the other, if you currently take opioids––including tramadol––for fibromyalgia, then this FDA announcement will also affect you.

Unintended Consequences of Changes in Opioid Prescribing Guidelines

An article published on April 24th, 2019 in the New England Journal of Medicine gives added emphasis to the importance of the FDA announcement. The three article authors, who were also authors of the CDC’s Guideline for Prescribing Opioids for Chronic Pain in 2016, point out that some of the policies and practices currently being used go far beyond the intent and recommendations of the guidelines.

An unintended consequence of expecting clinicians to mitigate risks of high-dose opioids is that rather than caring for patients receiving high dosages or engaging and supporting patients in efforts to taper their dosage, some clinicians may find it easier to refer or dismiss patients from care. Clinicians might universally stop prescribing opioids, even in situations in which the benefits might outweigh their risks. Such actions disregard messages emphasized in the guideline that clinicians should not dismiss patients from care, which can adversely affect patient safety, could represent patient abandonment, and can result in missed opportunities to provide potentially lifesaving information and treatment.

We can only hope that the FDA announcement, coupled with this new journal article, will help encourage doctors to work with their patients who take opioids rather than just cutting them off and leaving them to fend for themselves.


Karen Lee Richards is ProHealth’s Editor-in-Chief. A fibromyalgia patient herself, she co-founded the nonprofit organization now known as the National Fibromyalgia Association (NFA) in 1997 and served as its vice-president for eight years. She was also the executive editor of Fibromyalgia AWARE magazine. After leaving the NFA, Karen served as the Guide to Fibromyalgia and Chronic Fatigue Syndrome for the New York Times website About.com, then worked for eight years as the Chronic Pain Health Guide for The HealthCentral Network before coming to ProHealth. To learn more about Karen, see “Meet Karen Lee Richards.”


Resources:

U.S. Food and Drug Administration. FDA identifies harm reported from sudden discontinuation of opioid pain medicines and requires label changes to guide prescribers on gradual, individualized tapering. April 9, 2019. https://www.fda.gov/Drugs/DrugSafety/ucm635038.htm. Accessed April 24, 2019.

Peng X1, Robinson RL, Mease P, Kroenke K, Williams DA, Chen Y, Faries D, Wohlreich M, McCarberg B, Hann D. Long-term evaluation of opioid treatment in fibromyalgia. Clin J Pain. 2015 Jan;31(1):7-13. doi: 10.1097/AJP.0000000000000079.

Littlejohn GO, Guymer EK, Ngian GS. Is there a role for opioids in the treatment of fibromyalgia? Future Medicine. 2016 Jun. doi: 10.2217/pmt-2016-0012.

Dowell D, Haegerich T, Chou R. No Shortcuts to Safer Opioid Prescribing. N Engl J Med. 2016 April. Doi: 10.1056/NEJMp1904190

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