FDA Calls for Better Opioid Safety Labeling
The changes are based on observations from a May meeting between the Drug Safety and Risk Management Advisory Committee and the Anesthetic and Analgesic Drug Products Advisory Committee, which met to discuss two postmarketing requirement studies that assessed risk for abuse, addiction, and overdose in long-term use of opioid analgesics.
One of the observational studies showed that over 12 months of use, 1%-6% of the more than 2000 total participants met criteria for opioid addiction, 9% met criteria for prescription opioid abuse, and 22% met criteria for prescription opioid misuse.
In the second study, 5-year cumulative incidence estimates for opioid overdose-related death ranged from 1.5%-4.0%. In addition, 17% of first opioid overdoses over the entire 5-11 year study period were fatal.
The new safety-labeling requirements are a result of these findings, committee and public comments from the meeting, and recognition that there is currently an 'absence of adequate and well-controlled studies on long-term opioid effectiveness,' the FDA noted in a press release.
'The death of almost 1 million Americans during the opioid epidemic has been one of the cardinal failures of the public health establishment,' FDA commissioner Marty Makary, MD, said in the release.
30-Day Warning
The FDA has also called for a new prospective, randomized controlled trial to be conducted that will focus primarily on assessing risks and benefits of opioids used over the long term.
For now, the updated labeling should include a better explanation of risks, stronger warnings about higher doses, clarification about use limits, an emphasis that long-acting or extended-release opioids should only be used if shorter-acting opioids or other medications have proven inadequate, and a reminder about serious harm that can come if a patient who becomes physically dependent does not stop opioid use.
Additionally, the revised labels should provide information on possible opioid-related problems with the esophagus; on opioid overdose reversal agents; on toxic leukoencephalopathy, which can occur after overdose; and on negative drug-drug interactions, including gabapentinoids.
'This long-overdue labeling change is only part of what needs to be done — we also need to modernize our approval processes and postmarket monitoring,' Makary said. The release noted that OxyContin's drug application was first approved without supportive long-term use data.
The FDA added that manufacturers have 30 days to submit the newly required labeling updates for review.
Hashtags
Try Our AI Features
Explore what Daily8 AI can do for you:
Comments
No comments yet...
Related Articles
Medscape
39 minutes ago
- Medscape
Meta-Analysis Finds Biologic Switches Effective in Psoriasis
TOPLINE: Interclass biologic switching is effective and safe in patients with psoriasis, though switching from an anti-tumor necrosis factor (anti-TNF)-alpha to an anti-interleukin (IL)-17A treatment was associated with higher risk for adverse events (AEs), according to a meta-analysis. METHODOLOGY: To evaluate the safety and effectiveness of switching treatments after an initial biologic treatment fails, researchers conducted a meta-analysis of 24 randomized clinical trials published through January 25, 2025, which included 12,661 adults with psoriasis who switched from one biologic agent to another within the same class or in a different class. Eight switching categories were analyzed. The primary endpoint was the Psoriasis Area and Severity Index (PASI) 90 score, and secondary endpoints included safety. TAKEAWAY: PASI 90 improved significantly in patients after interclass biologic switching both at week 4 (11 studies; odds ratio [OR], 6.53; 95% CI, 2.58-16.51) and long term (OR, 28.61; 95% CI, 12.89-63.47). All switches were effective in the short term, whereas most switches achieved a PASI 90 response in the long term, except for switches from anti-IL-17A agents to anti-IL-17A/F agents. Long-term, marked improvements were observed when switching from anti-TNF-alpha agents to anti-IL-23p19 agents (OR, 23.72; 95% CI, 4.29-130.98) and from anti-IL-12/23p40 agents to anti-IL-23p19 agents (OR, 19.87; 95% CI, 10.40-37.94). No major safety differences were observed overall, except for increased serious adverse events (AEs) when switching from an anti-TNF-alpha agent to an anti-IL-17A agent (OR, 2.45; 95% CI, 1.25-4.83). Switching from anti-TNF-alpha agents to anti-IL-23p19, anti-IL-17A, or anti-IL-12/23p40 agents was associated with infection rates of 0.62%, 0.54%, and 0.39%, respectively. The highest risk for Candida infection (0.16%) was observed when switching from anti-TNF-alpha agents to anti-IL-17A/F agents. Switching to a different biologic class showed comparable effectiveness and safety with continuing the same agent, with regards to AEs. IN PRACTICE: This systematic review and meta-analysis found that 'interclass biologic switching was effective, and there were no safety differences for most patients,' the study authors wrote. 'Switching to anti-IL-23p19, anti-IL-17A, or anti-IL-12/23p40 agents from anti-TNF-alpha agents posed the greatest risk of infection,' they added, recommending 'vigilance for infections while switching to different biologics.' SOURCE: The study was led by Miao Zhang, MD, Department of Dermatology, Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai, China, and was published online on August 6 in JAMA Dermatology. LIMITATIONS: Limitations included heterogeneity in study designs, potential differences between biologics and batch variability which could have affected effectiveness comparisons after switching, insufficient data for several comparisons. DISCLOSURES: The study was supported by the National Natural Science Foundation of China, the Key Discipline Construction Project of Shanghai's 3-Year Action Plan for Strengthening the Construction of Public Health System, Shanghai Oriental Talent Program for Top-notch Project, CACMS Innovation Fund, Shanghai Healthy Special Project, The Shanghai 2022 Science and Technology Innovation Action Plan Medical Innovation Research Special Project, the Clinical Research Plan of Shanghai Shenkang Hospital Development Center, the High-level Chinese Medicine Key Discipline Construction Project, Evidence-based dermatology base sponsored by State Administration of Traditional Chinese Medicine, and the Shanghai Hospital Development Center Foundation. The authors reported having no conflicts of interest. This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.
Medscape
39 minutes ago
- Medscape
As Copay Aid Recedes, Retina Treatment ‘Unsustainable'
A funding shortfall for a key copay assistance program to help make eye injections more affordable for low-income patients has caused widespread disruption in treatment, researchers have found. Good Days is a nonprofit charitable organization set up to help people on Medicare who have retinal disease and other chronic conditions cover copays for treatments, such as intravitreal injections to treat age-related macular degeneration (AMD), diabetic macular edema, diabetic retinopathy, and geographic atrophy. Retina practices have reported the program, which receives financial support from Regeneron, stopped accepting new enrollees in 2025. According to the group's 2024 financial statements, Good Days — an arm of the Chronic Disease Fund, Inc. — provided funding to more than 422,000 patients that year and reported more than $480 million in contributions and grants. The new analysis, of more than 280,000 treated eyes in a national database of electronic health records, found people in low-income zip codes have been disproportionately affected by the loss of assistance. Ghassan Ghorayeb, MD, MBA 'There is clear evidence that the loss of copay assistance triggered widespread disruptions in evidence-based care,' Ghassan Ghorayeb, MD, MBA, a vitreoretinal specialist at West Virginia University in Morgantown, West Virginia, told Medscape Medical News . Ghorayeb presented the findings at the 2025 meeting of the American Society of Retina Specialists (ASRS) 2025 Annual Meeting in Long Beach, California. Ghorayeb said he and colleague Philip Niles, MD, MBA, undertook the two-part study — a survey of ASRS members paired with an analysis of real-world data — after 'the abrupt underfunding' of the Good Days program in late 2024. Most Vulnerable, Most Harm The analysis used electronic health record data from 340 retina specialists in 68 US practices collected from January 2024 to June 2025. The study included 146,551 eyes treated for AMD, 113,375 treated for diabetic macular edema, and 95,925 treated for geographic atrophy. The analysis calculated the effect of the funding shortfall on people who had switched out of more costly branded treatments to off-label bevacizumab (Avastin), which can cost between $50 and $80 per injection before copays. Bevacizumab is a cancer drug compounding pharmacies repackage for off-label ocular administration. Medicare and Medicaid cover the off-label use for retinal disease. According to a schedule posted by Retina Specialty Institute, a retina practice in three Southeastern states, out-of-pocket costs for branded intravitreal injections can range from $88 and $137 for ranibizumab 0.3 and 0.5 mg to $558 for a ranibizumab biosimilar and $537 for aflibercept 8 mg. 'We saw significant increases in off-label Avastin switching, sample reliance, and treatment discontinuation,' Ghorayeb told Medscape Medical News . 'These shifts were not benign: real-world data and physician surveys both linked them to higher rates of visual decline, particularly in economically disadvantaged zip codes. The most vulnerable patients experienced the most harm.' The analysis found switching from branded drugs to lower-cost bevacizumab has increased 45.6% for AMD and 37% for diabetic macular edema from 2024 to 2025, Ghorayeb reported. That translated into an increase in vision loss of 26% for the former patients and 19% for the latter. Clinicians in the study also relied more on using samples of medicines that were previously reimbursed, with a 44% increase for AMD injections, 8.3% for diabetic macular edema, and 203% for geographic atrophy, Ghorayeb said. While injections for geographic atrophy increased by 40% from 2023 to 2024 as new agents won FDA approval, injections for the indication have declined by 1% so far in 2025, he said. The study also tracked what Ghorayeb described as 'unsustainable' practices in clinics, when patients receive multiple samples of the same drug in a single eye or were switched to off-label bevacizumab despite declining vision with the drug. 'We found a sharp increase in unsustainable care patterns across the board, more than 30% in diabetic macular edema and hovering around 60% in wet AMD and geographic atrophy,' he told attendees at the meeting. Vision decline after switching from on-label therapies to bevacizumab were 44% more common in lower-income zip codes, Ghorayeb said. 'Not Marginal Effects' 'These are not marginal effects,' Ghorayeb told Medscape Medical News. 'They reflect real harm attributable to affordability-driven treatment changes.' Programs such as Good Days are 'fundamental to equitable care delivery,' he said. 'Even patients with Medicare or Medicare Advantage were unable to maintain their treatment regimens without supplemental support. Loss of assistance led to downgraded therapy, missed injections, and vision loss. We believe that maintaining copay support is a clinical and economic imperative.' Looming Medicaid cuts and reductions in Medicare reimbursements 'could tip the balance from unsustainable to untenable,' Ghorayeb said. 'Without systemic support, we risk abandoning our most vulnerable patients and undermining the gains made in treating retinal disease over the past two decades.' The study underscores a broader truth, he added: 'When the cost of care becomes a barrier, outcomes suffer.' Michael Lai, MD, PhD 'The study findings show that the economics of intravitreal injections are extremely fragile and tightly tethered to copay assistance programs,' Michael Lai, MD, PhD, a retina specialist at the Retinal Group of Washington, DC, told Medscape Medical News. 'A significant number of Medicare and Medicare Advantage patients depend on supplemental financial support to obtain necessary vision-saving retinal therapies.' The study demonstrated that disparities of care in lower-income communities 'are even greater than we had assumed,' Lai said. 'The underfunding of Good Days caught many patients and retina specialists off guard,' he added. 'All of the coping mechanisms we have resorted to so far, including switching to repackaged Avastin, using free samples and skipping or postponing injections, are unsustainable.' 'I sincerely hope that the information and data from this presentation will motivate all relevant stakeholders including industry partners, policymakers, and our societies to come together to find a solution to help our patients.' Ghorayeb had no relevant disclosures. Lai had served as a consultant to Apellis Pharmaceuticals.
Medscape
an hour ago
- Medscape
Brain Retraining Yields Lasting Relief of Chronic Back Pain
Psychological therapy that changes an individual's beliefs about pain can provide lasting relief for chronic back pain (CBP), long-term follow-up results of a randomized controlled trial showed. More than half of those who received the brain-focused pain reprocessing therapy (PRT) reported being nearly or completely pain-free 5 years later, outperforming placebo and usual care. While improved coping with chronic pain is the goal of some psychological treatments, 'our findings indicate that PRT can provide durable recovery from CBP for some patients,' noted the authors, led by Yoni Ashar, PhD, Department of Psychiatry, Weill Cornell Medical College, New York City. The study was published online on July 30 in JAMA Psychiatry . Retraining the Brain CBP is a leading cause of disability, and durable, nonpharmacologic treatments are scarce. PRT educates patients about the role of the brain in generating chronic pain, helps them reappraise their pain as they engage in movements that they had been afraid to undertake, and helps them address emotions that may exacerbate pain. The original study included 151 adults (54% women; mean age, 41 years) who had had primary CBP of low-to-moderate severity (mean pain intensity, 4 of 10) for an average of 10 years. In all, 50 participants were randomly allocated to PRT (one telehealth session with a physician and eight PRT sessions over 4 weeks), 51 to placebo (subcutaneous saline injection in the back), and 50 to continue their routine, usual ongoing care. As previously reported by Medscape Medical News , PRT led to large reductions in CBP severity, with benefits generally maintained through 1-year follow-up. A total of 113 (75%) participants completed the 5-year follow-up, including 38 in the PRT group, 39 in the placebo group, and 36 in the usual care group. At 5 years, PRT participants reported significantly lower pain intensity than placebo and usual care participants; the adjusted mean pain intensity was 1.93 in the PRT group vs 3.19 in the placebo and 2.60 in the usual care groups; PRT was superior to both comparators ( P = .006 vs placebo; P = .04 vs usual care). In the PRT group, 55% of PRT patients were nearly or completely pain free at 5 years vs 26% in the placebo and 36% in the usual care groups ( P = .03). Beyond pain intensity, PRT yielded significant improvements in pain interference, depression, anger, reduced kinesiophobia, and stronger attribution of pain to mind-brain processes. PRT had no significant differential effects at 5 years on sleep, anxiety, positive effect, catastrophizing, or perceived controllability of pain. The authors noted that the original sample had low-to-moderate baseline pain severity, and trials in higher-severity populations are needed to evaluate generalizability.
