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FDA Statement

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

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

For Immediate Release:
April 09, 2019
Statement From:
Statement Author
Leadership Role
Acting?
Leadership Role
Deputy Director for Regulatory Programs - About the Center for Drug Evaluation and Research
Acting?
Douglas Throckmorton MD

As the Department of Health and Human Services (HHS) continues to make progress against the opioid crisis, the FDA remains focused on striking the right balance between reducing the rate of new addiction by decreasing excessive exposure to opioids through rational prescribing, while still enabling appropriate access to treatment for patients living with serious pain. We are also committed to making sure that patients who use opioids take them correctly, and if opioid treatment is no longer needed, that patients and their healthcare providers know how to discontinue the medication safely. Proper discontinuation of opioids is important because everyone who is treated with opioids for any length of time develops a physical dependence—meaning there are withdrawal symptoms if the treatment suddenly stops. However, being physically dependent is very different than being addicted. In contrast to physical dependence, addiction also involves behaviors, thoughts and feelings such as: a strong desire to take the drug; difficulties in controlling drug use; persisting in drug use despite harmful consequences; and a higher priority given to drug use than to other activities and obligations.

Recently, the FDA has received reports of serious harm, including serious withdrawal symptoms, uncontrolled pain and suicide, in patients who are physically dependent on opioid pain medicines when these medicines are suddenly discontinued or when the dose is reduced too quickly, often without adequate patient communication, follow-up or support. These practices have also been associated with patients attempting to find other sources of opioids in order to minimize their withdrawal symptoms or self-medicate for pain. Patients may also attempt to treat their pain or withdrawal symptoms with illicit opioids, such as heroin and other substances. 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. 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.

Currently, FDA-approved labeling for opioid pain medications, as well as guidelines from the Centers for Disease Control and Prevention (CDC), describes the need to gradually reduce the dosage of an opioid medication over time, while monitoring carefully for signs of withdrawal. Yet, we know this is not always the way it’s handled in clinical practice. We need to do more to ensure that providers and patients have adequate guidance for safe opioid tapering.

That’s why today we’re requiring changes to the prescribing information for all opioid analgesic medicines used in the outpatient setting and issuing a Drug Safety Communication for health care providers and patients on this important issue. We’ll also engage with physician groups to walk through these updates, so they can provide the information to their members.

These changes will provide expanded information to health care providers on how to safely decrease the dose in patients who are physically dependent on opioids. This information is intended to be used when the health care provider and the patient have determined together that a decrease in dose or discontinuation of the opioid is appropriate.

When a health care provider and patient agree to taper the opioid, a variety of factors should be considered 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. These labeling changes also emphasize the importance of having informed discussions between patient and clinician and ensuring follow-up and support for patients managing pain and changes to their medication regimens.

There is no standard opioid tapering schedule suitable for all patients. Together, the health care provider and patient should agree on how to gradually reduce the dose of the opioid to avoid serious withdrawal symptoms, worsening of pain and psychological distress. Patients should be closely monitored during the opioid taper, and particularly for those who have been treated for a long duration and/or with higher doses for chronic pain, they should be offered a multimodal treatment approach including mental health support, as needed. If a substance use disorder is suspected, the patient should be assessed and treated using evidence-based strategies, such as medication-assisted treatment.

We’re constantly monitoring the safety of opioid pain medicines, and we’re also updating the prescribing information to include new information on other side effects of opioid use including central sleep apnea and drug interaction; we’ve also updated information on proper storage and disposal of these medicines consistent with the information available on our Disposal of Unused Medicines webpage.

At the FDA, we are continuing to aggressively confront the opioid crisis, while advancing policies to help make sure that patients with pain have access to appropriate, evidence-based care.

We’re working with the National Academies of Sciences, Engineering, and Medicine to help advance the development of evidence-based guidelines for appropriate opioid analgesic prescribing for acute pain resulting from specific conditions or procedures. The primary scope of this work is to understand what evidence is needed to ensure that clinical practice guidelines for opioid analgesic prescribing are sufficient and to identify what research is needed to generate that evidence in a practical and feasible manner.

Soon, we’ll also advance policies to require that immediate-release formulations of opioids be made available in fixed-quantity packaging – such as blister packs – that contain doses (e.g., tablets) more typical of what patients may need for common acute pain conditions and procedures. Our data shows that many acute pain indications for which opioids are prescribed, such as post-surgical indications, require just one or two days of analgesic medicines. By having opioids packaged in fixed-quantity units (e.g., one or two days of pills), we believe providers will be more likely to write prescriptions for these short durations, and it will discourage the dispensing of 30 pill supplies, a prescribing practice that is still too common.

The FDA remains committed to addressing the opioid crisis on all fronts, with a significant focus on decreasing unnecessary exposure to opioids and preventing new addiction; supporting the treatment of those with opioid use disorder; fostering the development of novel pain treatment therapies and opioids more resistant to abuse and misuse; and taking action against those involved in the illegal importation and sale of opioids. The agency will also continue to evaluate how opioids currently on the market are used, in both medical and illicit settings, and take regulatory action where needed.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

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