Lance's Corner

FDA Issues Safety Alert on Opioids

Aug 4, 2025

Per the notice below, the United States Food and Drug Administration (FDA) has issued a safety alert on use of opioid drugs.

MedWatch - The FDA Safety Information and Adverse Event Reporting Program

TOPIC: FDA is Requiring Opioid Pain Medicine Manufacturers to Update Prescribing Information Regarding Long-Term Use.  Class-Wide Action Will Further Emphasize and Characterize Risks of Long-Term Use to Help Patients, Health Care Professionals Make Informed Treatment Decisions: Drug Safety Communication

AUDIENCE: Patient, Health Care Professional, Pain Management

ISSUE: In May 2025, the FDA convened a joint meeting of the Drug Safety and Risk Management Advisory Committee and the Anesthetic and Analgesic Drug Products Advisory Committee to discuss two recently completed observational studies examining the risks of misuse, abuse, addiction, and fatal and non-fatal overdose in patients on long-term opioid analgesic (also referred to as opioid pain medicine) therapy.  These studies (postmarketing requirements [PMR] 3033-1 and 3033-2) provided new, quantitative data on risks of these serious adverse outcomes in patients prescribed opioid pain medicines long term.  After reviewing the study findings and the medical literature, as well as considering the committees’ and public input, FDA has determined that this new information should be included in drug labeling to help health care professionals and patients better understand the benefit-risk profile of opioid pain medicines when prescribed long term and to make more informed decisions.  Separately, a prospective, randomized, controlled clinical trial will address a different PMR to examine the risks relative to the efficacy of long-term opioid use.  For more information about this alert, click on the red button "Read Alert" below.

BACKGROUND: Opioid pain medicines are powerful prescription medicines that can help manage pain when other treatments and medicines are not able to provide enough relief.  However, opioid pain medicines also carry serious risks, including misuse and abuse, addiction, overdose, and death.

RECOMMENDATIONS:

Health Care Professionals

  • In assessing the severity of pain, discuss with the patient the source of the pain and the impact of the pain on their ability to function and their quality of life.
  • If the patient’s pain is severe enough to require an opioid pain medicine and alternative treatment options are insufficient, prescribe the lowest effective dose of an immediate-release (IR) opioid pain medicine for the shortest duration of time needed to reduce the risks associated with these products.
  • Reserve extended-release/long-acting opioid pain medicines only for severe and persistent pain that cannot be adequately treated with alternative options, including IR opioid pain medicines.
  • For all patients prescribed opioid pain medicines, discuss opioid overdose reversal agents, such as naloxone and nalmefene.
  • Regularly re-evaluate the benefit-risk profile for any individual taking opioid pain medicines for more than a few days.  If you determine opioid pain medicines are indicated, consider an IR opioid pain medicine as an as-needed, first-line treatment.
  • Avoid rapidly reducing or abruptly discontinuing opioid pain medicines in patients who may be physically dependent on the medication because such changes have resulted in serious withdrawal symptoms, uncontrolled pain, and suicide.

Patient or Parent/Caregiver

  • Always take your opioid pain medicine exactly as prescribed.  Do not take more of the medicine or take it more often than prescribed without first talking to your health care professional.  Talk with them if your pain increases, you feel more sensitive to pain, or if you have new pain, especially from touch or other things that are not usually painful such as combing your hair.
  • Store your opioid pain medicines securely, out of sight and reach of children and pets, and in a location not accessible by others, including home visitors.  Do not share these medicines with anyone else, and immediately dispose of unused or expired opioid pain medicines or take them to a drug take-back site, location, or program.  If provided, use the prepaid mail-back envelopes included with the prescription.
  • Seek emergency medical help or call 911 immediately if you or someone you are caring for experiences symptoms of respiratory problems, which can be life-threatening.  Signs and symptoms include slowed, shallow, or difficult breathing, severe sleepiness, or not being able to respond or wake up.
  • Talk to your health care professionals about the benefits of naloxone and nalmefene, which can reverse an opioid overdose, and how to obtain these drugs.
  • Be aware that overdose risks are increased with higher opioid pain medicine doses and that the risks of serious harms persist over the course of therapy.  Avoid rapidly reducing or abruptly discontinuing opioid pain medicine treatment without consulting a health care professional.

[07/31/2025 - Drug Safety Communication - FDA]
[07/31/2025 - Press Release - FDA]

Health care professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
  • Complete and submit the report online.
  • Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on form, or submit by fax to 1-800-FDA-0178.
Read Alert Button

USDOL Issues Comprehensive Employer Guidance on Long COVID

The United States Department of Labor (USDOL) has issued a comprehensive set of resources that can be accessed below for employers on dealing with Long COVID.

Supporting Employees with Long COVID: A Guide for Employers

The “Supporting Employees with Long COVID” guide from the USDOL-funded Employer Assistance and Resource Network on Disability Inclusion (EARN) and Job Accommodation Network (JAN) addresses the basics of Long COVID, including its intersection with mental health, and common workplace supports for different symptoms.  It also explores employers’ responsibilities to provide reasonable accommodations and answers frequently asked questions about Long COVID and employment, including inquiries related to telework and leave.

Download the guide

Accommodation and Compliance: Long COVID

The Long COVID Accommodation and Compliance webpage from the USDOL-funded Job Accommodation Network (JAN) helps employers and employees understand strategies for supporting workers with Long COVID.  Topics include Long COVID in the context of disability under the Americans with Disabilities Act (ADA), specific accommodation ideas based on limitations or work-related functions, common situations and solutions, and questions to consider when identifying effective accommodations for employees with Long COVID.  Find this and other Long COVID resources from JAN, below:

Long COVID, Disability and Underserved Communities: Recommendations for Employers

The research-to-practice brief “Long COVID, Disability and Underserved Communities” synthesizes an extensive review of documents, literature and data sources, conducted by the USDOL-funded Employer Assistance and Resource Network on Disability Inclusion (EARN) on the impact of Long COVID on employment, with a focus on demographic differences.  It also outlines recommended actions organizations can take to create a supportive and inclusive workplace culture for people with Long COVID, especially those with disabilities who belong to other historically underserved groups.

Read the brief

Long COVID and Disability Accommodations in the Workplace

The policy brief “Long COVID and Disability Accommodations in the Workplace” explores Long COVID’s impact on the workforce and provides examples of policy actions different states are taking to help affected people remain at work or return when ready.  It was developed by the National Conference of State Legislatures (NCSL) as part of its involvement in USDOL’s State Exchange on Employment and Disability (SEED) initiative.

Download the policy brief

Understanding and Addressing the Workplace Challenges Related to Long COVID

The report “Understanding and Addressing the Workplace Challenges Related to Long COVID” summarizes key themes and takeaways from an ePolicyWorks national online dialogue through which members of the public were invited to share their experiences and insights regarding workplace challenges posed by Long COVID.  The dialogue took place during summer 2022 and was hosted by USDOL and its agencies in collaboration with the Centers for Disease Control and Prevention and the U.S. Surgeon General.

Download the report

Working with Long COVID

The USDOL-published “Working with Long COVID” fact sheet shares strategies for supporting workers with Long COVID, including accommodations for common symptoms and resources for further guidance and assistance with specific situations.

Download the fact sheet

COVID-19: Long-Term Symptoms

This USDOL motion graphic informs workers with Long COVID that they may be entitled to temporary or long-term supports to help them stay on the job or return to work when ready, and shares where they can find related assistance.

Watch the motion graphic

A Personal Story of Long COVID and Disability Disclosure

In the podcast “A Personal Story of Long COVID and Disability Disclosure,” Pam Bingham, senior program manager for Intuit’s Diversity, Equity and Inclusion in Tech team, shares her personal experience of navigating Long COVID symptoms at work.  The segment was produced by the USDOL-funded Partnership on Employment and Accessible Technology (PEAT) as part of its ongoing “Future of Work” podcast series.

Listen to the podcast

HHS OIG Issues Annual Report on State MFCUs

Per the notice below, the Office of the Inspector General (OIG) of the United States Department of Health and Human Services (HHS) has issued its annual report on the performance of state Medicaid Fraud Control Units (MFCUs).

Medicaid Fraud Control Units Fiscal Year 2023 Annual Report (OEI-09-24-00200) 

Medicaid Fraud Control Units (MFCUs) investigate and prosecute Medicaid provider fraud and patient abuse or neglect. OIG is the Federal agency that oversees and annually approves federal funding for MFCUs through a recertification process. This new report analyzed the statistical data on annual case outcomes—such as convictions, civil settlements and judgments, and recoveries—that the 53 MFCUs submitted for Fiscal Year 2023.  New York data is as follows:

Outcomes

  • Investigations1 - 556
  • Indicted/Charged - 9
  • Convictions - 8
  • Civil Settlements/Judgments - 28
  • Recoveries2 - $73,204,518

Resources

  • MFCU Expenditures3 - $55,964,293
  • Staff on Board4 - 257

1Investigations are defined as the total number of open investigations at the end of the fiscal year.

2Recoveries are defined as the amount of money that defendants are required to pay as a result of a settlement, judgment, or prefiling settlement in criminal and civil cases and may not reflect actual collections.  Recoveries may involve cases that include participation by other Federal and State agencies.

3MFCU and Medicaid Expenditures include both State and Federal expenditures.

4Staff on Board is defined as the total number of staff employed by the Unit at the end of the fiscal year.

Read the Full Report

View the Statistical Chart

Engage with the Interactive Map

GAO Issues Report on Medicaid Managed Care Service Denials and Appeal Outcomes

The United States Government Accountability Office (GAO) has issued a report on federal use of state data on Medicaid managed care service denials and appeal outcomes.  GAO found that federal oversight is limited because it doesn't require states to report on Medicaid managed care service denials or appeal outcomes and there has not been much progress on plans to analyze and make the data publicly available.  To read the GAO report on federal use of state data on Medicaid managed care service denials and appeal outcomes, use the first link below.  To read GAO highlights of the report on federal use of state data on Medicaid managed care service denials and appeal outcomes, use the second link below.
https://www.gao.gov/assets/d24106627.pdf  (GAO report on federal use of state data on Medicaid managed care service denials and appeal outcomes)
https://www.gao.gov/assets/d24106627_high.pdf  (GAO highlights on federal use of state data on Medicaid managed care service denials and appeal outcomes)

CMS Issues Latest Medicare Regulatory Activities Update

The Centers for Medicare and Medicaid Services (CMS) has issued its latest update on its regulatory activities in the Medicare program.  While dentistry is only minimally connected to the Medicare program, Medicare drives the majority of health care policies and insurance reimbursement policies throughout the country.  Therefore, it always pays to keep a close eye on what CMS is doing in Medicare.  To read the latest CMS update on its regulatory activities in Medicare, use the link below.
https://www.cms.gov/training-education/medicare-learning-network/newsletter/2024-03-14-mlnc