FDA Clarifies Policies for Compounders as National GLP-1 Supply Begins to Stabilize
The FDA has resolved the shortage of semaglutide injection products, a glucagon-like peptide 1 (GLP-1) medication, meeting US demand, ending a nearly 3-year shortage. Patients and prescribers may still see intermittent and limited localized supply disruptions as the products move through the supply chain from the manufacturer and distributors to local pharmacies.
KEY FINDINGS: The FDA has resolved the shortage of semaglutide injection products, a glucagon-like peptide 1 (GLP-1) medication, meeting US demand, ending a nearly 3-year shortage. Patients and prescribers may still see intermittent and limited localized supply disruptions as the products move through the supply chain from the manufacturer and distributors to local pharmacies.
BACKGROUND: FDA has determined the shortage of semaglutide injection products, a glucagon-like peptide 1 (GLP-1) medication, is resolved. Semaglutide injection products have been in shortage since 2022 due to increased demand.
DETAILS: FDA confirmed with the drug's manufacturer that their stated product availability and manufacturing capacity can meet the present and projected national demand. Patients and prescribers may still see intermittent and limited localized supply disruptions as the products move through the supply chain from the manufacturer and distributors to local pharmacies.
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To avoid unnecessary disruption to patient treatment, the agency does not intend to take action against compounders for violations of the FD&C Act arising from conditions that depend on semaglutide injection products’ inclusion on FDA’s drug shortage list:
- For a state-licensed pharmacy or physician compounding under section 503A of the FD&C Act: compounding, distributing or dispensing semaglutide injection products that are essentially a copy of an FDA-approved product within 60 calendar days from today's announcement, until April 22, 2025.
- For outsourcing facilities under section 503B of the FD&C Act: compounding, distributing or dispensing semaglutide injection products that are essentially a copy of an FDA-approved drug product within 90 calendar days from today’s announcement, until May 22, 2025. FDA may still take action regarding violations of any other statutory or regulatory requirements, such as to address findings that a product may be of substandard quality or otherwise unsafe.
Current shortage status of other GLP-1 products (as of February 21, 2025):
FDA continues to actively monitor drug availability and is currently working to determine whether the demand or projected demand for each drug in shortage exceeds the available supply.
- Dulaglutide injection: In shortage. Manufacturer has reported all presentations are available.
- Liraglutide injection: In shortage. Manufacturer has reported two presentations are available, and three have limited availability.
Source: FDA cLarifies Policies for Compounders as National GLP-1 Supply Begins to Stabilize. FDA. Published: February, 21, 2025.
Potassium Binders May Support Continued RAAS Inhibitor Therapy in Chronic Kidney Disease and Heart Failure
Second-generation potassium binders were associated with greater persistence of RASi and MRA therapy than first-generation binders. Continued RASi use was associated with lower observed mortality and hospitalization, but not with a clear difference in 3P-MACE. These findings suggest potassium binders may facilitate sustained RAASi therapy in CKD and HF.
KEY FINDINGS: In this Swedish nationwide observational cohort, second-generation potassium binders were associated with greater persistence of RASi and MRA therapy at 6 months than first-generation binders. RASi persistence was also associated with lower observed all-cause mortality and hospitalization, although no clear difference in 3P-MACE was identified. The findings support the potential role of potassium binders in maintaining guideline-directed RAASi therapy in patients with CKD and/or HF.
BACKGROUND: Renin–angiotensin–aldosterone system inhibitors (RAASi) provide important cardiorenal benefits in chronic kidney disease (CKD) and heart failure (HF), but their use can increase the risk of hyperkalemia. Hyperkalemia frequently leads to RAASi discontinuation despite the benefits of continued therapy. This study evaluated whether potassium binders, particularly second-generation agents, were associated with greater persistence of RAASi and mineralocorticoid receptor antagonist (MRA) therapy.
DETAILS:
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Source: Furuland, H., Larsson, A. O., Uhde, M., et al. Potassium Binders and Continuation of Renin–Angiotensin System Inhibitors/Mineralocorticoid Receptor Antagonist in Chronic Kidney Disease and Heart Failure (the DEMONSTRATE Database. Journal of Internal Medicine. 2026; 300(2): 179-192. Published: Augusts, 2026. DOI: 10.1111/joim.70087.
Hyponatremia Treatment Guidelines: Maintain Cautious Correction to Prevent Osmotic Demyelination
Current hyponatremia correction safeguards should be maintained. For chronic hyponatremia with sodium 120 mmol/L or lower, correction should generally remain within 10-12 mmol/L in 24 hours and 18 mmol/L in 48 hours; high-risk patients require a stricter limit of 8 mmol/L in 24 hours. Frequent monitoring and desmopressin may prevent overcorrection.
KEY FINDINGS: Current safeguards for severe hyponatremia remain warranted despite recent evidence questioning restrictive correction limits. Correction should be particularly cautious in patients with sodium ≤105 mmol/L or other ODS risk factors. Frequent serum sodium measurement and urine-output monitoring are essential because spontaneous water diuresis can cause rapid sodium increases. Desmopressin may help prevent or reverse excessive correction.
BACKGROUND: Severe hyponatremia can cause life-threatening neurologic complications, while overly rapid correction can result in osmotic demyelination syndrome (ODS). Recent retrospective evidence has questioned whether existing correction limits are overly restrictive. This review reassesses the evidence supporting current treatment safeguards and emphasizes continued caution when correcting severe hyponatremia.
DETAILS: The review examines the evidence underlying international recommendations for limiting the rate of serum sodium correction, with particular attention to patients with severe or chronic hyponatremia. The authors discuss evidence linking rapid correction with ODS and review data that have challenged the need for conservative correction limits.
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For chronically hyponatremic patients with serum sodium ≤120 mmol/L who are at normal risk for ODS, the US/Irish expert panel recommends limiting correction to 10–12 mmol/L during any 24-hour period and 18 mmol/L during any 48-hour period, with a minimum correction of 4–8 mmol/L. Patients at increased risk of ODS—including those with sodium ≤105 mmol/L, alcohol use disorder, hypokalemia, malnutrition, or advanced liver disease—should have correction limited to 8 mmol/L in any 24-hour period, with a minimum daily correction goal of 4–6 mmol/L.
For patients with severe symptoms, European and US/Irish recommendations support bolus administration of hypertonic saline to increase serum sodium by approximately 5 mmol/L or 4–6 mmol/L, respectively, within a few hours. The review notes that this initial increase can substantially reduce intracranial pressure and may reverse impending brain herniation.
The review concludes that current safeguards for treating severe hyponatremia should not be abandoned. Excessive increases in serum sodium can occur because of sudden elimination of dilute urine rather than excessive saline administration. Water diuresis may increase serum sodium by more than 2 mmol/L per hour, emphasizing the need for frequent serum sodium measurements and close monitoring of urine output in patients with sodium ≤120 mmol/L.
Desmopressin can be used to prevent or reverse inadvertent overcorrection. A strategy involving scheduled desmopressin with controlled hypertonic saline administration, termed the "DDAVP clamp"", has been reported to help achieve correction targets, although comparative evidence remains limited.
The review highlights that patients with sodium ≤105 mmol/L and additional risk factors for ODS are particularly vulnerable. If correction exceeds 8 mmol/L in less than 24 hours in these high-risk patients, relowering the serum sodium should be considered.
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Source: Sterns, R. H., Rondon-Berrios, H., Adrogué, H. J., et al. Treatment Guidelines for Hyponatremia: Stay the Course. Clinical Journal of the American Society of Nephrology. 2026; 19(1): 129-135. Published: January, 2024. DOI: 10.2215/CJN.0000000000000244.
First Birth by Cesarean Delivery Associated With Reduced Subsequent Live Birth and Increased Use of Assisted Reproduction
First birth by cesarean delivery was associated with an 11% lower likelihood of a subsequent live birth and a 28% greater likelihood of IVF or any ART use to achieve a second birth. The findings persisted across elective and emergency cesarean deliveries, although causality cannot be established from this observational study.
KEY FINDINGS: In this large population-based cohort, women whose first birth was by cesarean delivery had an 11% lower likelihood of a second live birth within the 12-year study period and were 28% more likely to use IVF or any ART to achieve a subsequent birth after adjustment for measured confounders. The associations were observed for both elective and emergency cesarean deliveries. No meaningful association with miscarriage was identified, and the difference in interpregnancy interval was small.
BACKGROUND: Cesarean delivery is one of the most common obstetric interventions worldwide. Although cesarean delivery can be medically necessary and life-saving, its potential long-term effects on subsequent reproductive outcomes remain incompletely understood. This study evaluated whether cesarean delivery at first birth was associated with subsequent live birth, use of in vitro fertilization (IVF) or other assisted reproductive technologies (ART), interpregnancy interval, and miscarriage.
DETAILS: This retrospective population-based cohort study included women who had their first spontaneously conceived, singleton live birth in Victoria, Australia, between January 2005 and December 2015. Follow-up for subsequent births continued through December 2017. Women with prior ART use, multiple pregnancies, stillbirths, missing mode of delivery, or unreliable linkage between first and second births were excluded.
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The final cohort included 298,241 women: 205,164 (68.8%) had a vaginal first birth and 93,077 (31.2%) had a cesarean delivery. Among the cesarean deliveries, 33,041 (35.5%) were elective and 60,036 (64.5%) were emergency procedures. A total of 184,061 (61.7%) women had both their first and second births during the 12-year study period.
The primary outcomes were the likelihood of a second live birth within the study period and the requirement for IVF or other ART to achieve a second birth. Secondary outcomes included interpregnancy interval and miscarriage. Analyses adjusted for maternal age, Socio-Economic Indexes for Areas (SEIFA) quintile, chronic hypertension, and preexisting diabetes; age at second birth was additionally considered for outcomes involving a second birth.
First birth by cesarean delivery was associated with a lower probability of a subsequent live birth. The crude hazard ratio was 0.86 (95% CI, 0.85—0.87), while the adjusted hazard ratio was 0.89 (95% CI, 0.88—0.90), corresponding to an 11% reduction after adjustment. The association persisted in the cohort restricted to women whose first birth occurred before 2013, with an adjusted hazard ratio of 0.89 (95% CI, 0.88—0.90).
Among women who had a second live birth, IVF use was increased by 70% in the crude analysis (RR, 1.70; 95% CI, 1.52—1.89) and by 28% after adjustment (adjusted RR, 1.28; 95% CI, 1.15—1.43). Use of any ART was also increased by 28% (adjusted RR, 1.28; 95% CI, 1.15—1.43). These associations persisted when analyses were stratified by elective versus emergency cesarean delivery and when restricted to term births.
No significant difference in miscarriage was identified after adjustment (adjusted RR, 1.01; 95% CI, 0.98—1.03). Although cesarean delivery was associated with a small increase in the median interpregnancy interval, the adjusted median difference was 0.08 months (95% CI, 0.01—0.16), which the investigators considered unlikely to be clinically significant.
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Source: Pritchard, N. L., Hiscock, R. J., Hastie, R., et al. The Impact of First Birth by Cesarean Delivery on Subsequent Reproductive Outcomes—a Population Cohort Study. American Journal of Obstetrics & Gynecology. 2026; 235(2): 338-346. Published: August, 2026. DOI: 10.1016/j.ajog.2026.03.006.
FDA Launches TEMPO Pilot to Evaluate Digital Health Devices for Chronic Disease Management
FDA's TEMPO pilot selected its first participant, Dexcom Glucose Health Program, to evaluate digital health technology for chronic disease management within the CMS ACCESS Model. The pilot will generate real-world evidence on safety, performance, and patient outcomes while exploring technology-enabled approaches for metabolic health care.
KEY FINDINGS: The FDA's TEMPO pilot establishes a regulatory pathway for evaluating digital health devices designed to improve chronic disease outcomes through real-world evidence generation. The first selected participant, Dexcom's Glucose Health Program, focuses on metabolic monitoring, AI-supported insights, and behavioral guidance for individuals aligned with the CMS ACCESS Model. The pilot may provide important insights into how digital health technologies can be incorporated into future models of preventive and chronic disease care while maintaining patient safety standards.
BACKGROUND: Digital health technologies are increasingly being developed to support chronic disease prevention and management through remote monitoring, real-time data collection, and personalized care interventions. The U.S. Food and Drug Administration (FDA), in collaboration with the Centers for Medicare & Medicaid Services (CMS) Innovation Center, launched the Technology-Enabled Meaningful Patient Outcomes (TEMPO) for Digital Health Devices Pilot to promote access to selected digital health devices while maintaining patient safety oversight and generating real-world evidence.
DETAILS: The FDA announced the first manufacturer selected for the TEMPO pilot: Dexcom, Inc. The selected device program, Dexcom Glucose Health Program, will be evaluated for intended uses within the CMS Innovation Center's Advancing Chronic Care with Effective, Scalable Solutions (ACCESS) Model.
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The Dexcom Glucose Health Program is intended to allow patients participating in the ACCESS Model, along with healthcare professionals and caregivers, to monitor metabolic and nutritional status, receive individualized guidance, and use real-time data and artificial intelligence (AI)-based insights to support decision-making and behavioral modifications. The program is also intended to assist in screening for prediabetes and type 2 diabetes using integrated digital health metrics and may contribute to improved glycemic control and lower HbA1c levels in individuals with prediabetes.
Manufacturers participating in TEMPO will collect, monitor, and report real-world data related to device performance and intended clinical uses. The pilot is designed to help FDA and CMS understand how digital health technologies perform in real-world healthcare settings and their potential role in improving outcomes for individuals living with chronic diseases.
The FDA plans to select up to approximately 10 TEMPO pilot participants in each of four ACCESS Model clinical use areas. Selection considerations include potential patient safety risks, expected patient benefit, real-world data collection plans, monitoring strategies, and alignment with measurable clinical outcomes.
The first TEMPO participant selection represents an initial step toward integrating digital health technologies into technology-supported chronic disease care pathways. The FDA will continue evaluating participating technologies through real-world evidence collection rather than relying solely on traditional premarket assessment approaches for the pilot setting.
The Dexcom Glucose Health Program will be assessed within early cardio-kidney-metabolic (eCKM) and cardio-kidney-metabolic (CKM) clinical use areas under the ACCESS Model. The evaluation will focus on whether digital monitoring, personalized guidance, and AI-supported insights can support improved patient outcomes in chronic metabolic disease management.
The FDA emphasized that the effectiveness of selected devices for their intended uses within the TEMPO pilot has not yet been established and that the program is intended to generate evidence while expanding responsible access to digital health innovations.
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Source: FDA Announces First Participant Selected for TEMPO for Digital Health Devices Pilot. Food and Drug Administration. 2026; Published: July 22, 2026.
2026 Dyslipidemia Guideline Expands Eligibility for Primary Prevention Statin Therapy in US Adults
The 2026 dyslipidemia guideline substantially expands primary prevention statin eligibility in US adults, with an estimated 87.5 million adults (56.6% of the target population) eligible for therapy, including 21.5 million newly eligible individuals. The expansion primarily affects younger, lower-risk adults compared with prior recommendations.
KEY FINDINGS: The 2026 dyslipidemia guideline substantially increases the number of US adults recommended for primary prevention statin therapy. This expansion includes a large group of individuals who were not previously considered candidates for statins and who generally have lower estimated 10-year ASCVD risk. The findings highlight the potential impact of updated risk assessment strategies on preventive cardiovascular care and clinical decision-making regarding statin initiation.
BACKGROUND: The 2026 American Heart Association/American College of Cardiology/multisociety guideline on dyslipidemia introduced updated recommendations for estimating atherosclerotic cardiovascular disease (ASCVD) risk and determining eligibility for primary prevention statin therapy. This study evaluated the projected population-level impact of these updated recommendations compared with the 2018 lipid guidelines.
DETAILS: This nationally representative cross-sectional study analyzed data from nonpregnant adults aged 30 to 79 years without known ASCVD who participated in the National Health and Nutrition Examination Survey (NHANES) from 2017 to 2023. The analysis included 4366 participants representing 154.5 million US adults. Data were analyzed from March to May 2026.
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The study compared statin eligibility under the 2026 dyslipidemia guideline with recommendations from the 2018 lipid guidelines. The investigators assessed the proportion of adults eligible for primary prevention statin therapy, including individuals qualifying based on low-density lipoprotein cholesterol (LDL-C) levels, diabetes, chronic kidney disease, or ASCVD risk estimation.
The study estimated that the 2026 guideline would expand primary prevention statin eligibility to 21.5 million US adults who were not previously recommended statin therapy. Overall, 87.5 million US adults (56.6% of the target population) were estimated to be eligible for statins under the new guideline.
Among the weighted sample, 5.5% (95% CI, 4.7%-6.6%) had untreated LDL-C below 70 mg/dL, 17.8% (95% CI, 16.3%-19.5%) reported current statin use, and 8.6% (95% CI, 7.6%-9.8%) met criteria for statin therapy independent of ASCVD risk estimation based on LDL-C of 190 mg/dL or greater, diabetes, or chronic kidney disease.
Eligibility increased substantially among older adults, with more than 93% of adults aged 70 to 79 years and 85% of adults aged 60 to 69 years meeting criteria for primary prevention statin therapy, compared with 11% of adults aged 30 to 39 years.
The newly eligible population generally represented younger and lower-risk adults compared with those previously recommended statins. The mean estimated 10-year ASCVD risk was 3.1% (95% CI, 2.7%-3.5%) among newly eligible individuals compared with 6.1% (95% CI, 5.8%-6.4%) among those previously eligible.
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Source: Anderson, T. S., Wilson, L. M., and Sussman, J. B. Implications of the 2026 Dyslipidemia Guideline for Primary Prevention Statin Therapy. JAMA. 2026; Published: July 20, 2026. DOI: 10.1001/jama.2026.11246
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