Women with early bilateral oophorectomy at high risk of Alzheimer’s Disease, reports research

A new study published in the Journal of Alzheimer’s Disease showed that Alzheimer disease risk is increased by early bilateral oophorectomy (BO). By 2050, it is anticipated that 12.7 million people 65 and older would have Alzheimer’s disease (AD). Two-thirds of the individuals with AD are female. Therefore, reducing the number of people who acquire AD requires an awareness of the unique risk and resilience variables associated with AD in women.

The decrease of 17β-estradiol (E2) during menopause is a significant sex-related component. A few studies have examined women’s risk for dementia from all causes using the UK Biobank, a prospective population-based database of over 500,000 people with comprehensive phenotypic and genetic data. However, the findings involving menopause are conflicting. In fact, there is currently ample evidence linking early BO to a higher risk of dementia and/or cognitive impairment.In order to compare the odds ratios of AD to those of women who experienced spontaneous menopause (SM), this study looked at the prevalence and determinants of AD in women with early BO.

Women with early BO or SM who were 60 years of age or older at baseline, with or without AD, were included in a UK Biobank cohort (n = 34,603). The ICD-10 or ICD-9 code associated with AD was used to determine AD. To model the relationship between menopausal type and AD, this study employed logistic regression. Age, education, menopausal age, hormone treatment (HT), APOE4, body mass index (BMI), history of cancer, and history of smoking were all model variables.

The odds of developing AD were 4-times higher for individuals with early BO than for those with SM. In the BO group, older age and APOE4 were linked to higher risks of AD. While ever using HT was linked to lower odds of AD exclusively for the BO group, more years of schooling were linked to lower risks of AD for both BO and SM.

Overall, the probabilities of AD in women with early BO were determined by this investigation. The probabilities of AD were significantly raised by early BO itself. In addition, among women with early BO, possessing one or more APOE4 allele was substantially associated with higher risks of AD. Higher BMI, more education, and ever using HT were linked to lower risks.

Reference:

Calvo, N., McFall, G. P., Ramana, S., Galper, M., Fuller-Thomson, E., Dixon, R. A., & Einstein, G. (2024). Associated risk and resilience factors of Alzheimer’s disease in women with early bilateral oophorectomy: Data from the UK Biobank. In Journal of Alzheimer’s Disease (Vol. 102, Issue 1, pp. 119–128). SAGE Publications. https://doi.org/10.3233/jad-240646

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Incorporating Arginine in fancy water beverages lowers erosive tooth wear potential of these beverages: Study

Researchers have reported that the addition of arginine (Arg) in flavored fancy waters significantly lowers their potential to cause erosive tooth wear. Erosive tooth wear is a progressive loss of enamel caused by acidic beverages, commonly seen among young people. A recent study was conducted by Mohammed N. and colleagues published in the Journal of Dentistry.

With the increased popularity of flavored sparkling and carbonated beverages, erosive wear is an important issue. The oral health benefits of L-arginine have been reported in various studies. In this study, the efficacy of five commercially available fancy waters containing L-arginine was tested in reducing tooth wear over a controlled period of 72 hours.

The five commercial fancy waters, Oasis Lemon, Oasis Lemon Mint, Perrier Lemon, Perrier Grapefruit, and Pellegrino Lemon, were enriched with 2% L-arginine (w/v). Deionized water was used as a negative control. Key parameters, such as pH, buffer capacity, and fluoride (F−) concentrations, were measured to determine the impact of arginine addition.

To prepare, specimens were subjected to baseline volumetric analysis using micro-CT imaging. The specimens were then placed in the beverages for 72 hours at 37°C, with solutions changed every 24 hours. Post-exposure, 3D volumetric assessments and structural reconstructions were conducted to quantify and visualize enamel wear.

Key Findings

Improved pH and Fluoride Concentrations::

  • Fancy waters with arginine had significantly higher pH and fluoride concentration compared to the control (p < 0.001).

Buffer Capacity:

  • Among the arginine-rich drinks, Perrier-Grapefruit had the highest buffer capacity, which was significantly higher than Oasis Lemon, Oasis Lemon Mint, and Pellegrino Lemon (p < 0.05).

Enamel Volume Retention:

  • The specimens treated with Oasis Lemon Mint (± arginine) and Pellegrino Lemon (control) showed significant volume loss compared to baseline (p < 0.05).

  • Arginine-containing drinks had higher specimen volume compared to the non-arginine counterparts, thus proving their protective role.

Surface Wear Evidence:

  • Surface contrast imaging showed evident wear from baseline (T0) to the final analysis (T1) in specimens treated with Oasis Lemon Mint (± arginine) and Pellegrino Lemon without arginine.

Arginine enrichment of flavored fancy waters may minimize their erosive potential. This may provide a preventive mechanism against enamel wear and tear. The current research findings suggest that the formulation of beverages should be addressed to meet oral health needs without compromising consumer appeal. This would help reduce the burden of dental erosion among at-risk populations by promoting arginine-enriched beverages.

Reference:

Bijle, Mohammed Nadeem & Sharaf, Dalya & BAHDAR, Moussa & Daood, Umer & Yiu, Cynthia. (2024). Preventive potential of arginine incorporated in fancy waters for erosive tooth wear. Journal of Dentistry. 153. 10.1016/j.jdent.2024.105500.

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New clinical practice guideline on process for diagnosing Alzheimer’s disease or related form of cognitive impairment or dementia

We have entered a new era of improved and emerging biologically-based diagnostic biomarkers for Alzheimer’s disease (AD) and AD-related neurodegenerative disorders (ADRD) that are rapidly impacting evaluation and care paradigms in every clinical setting: primary care, specialty care and dementia subspecialty care.

A comprehensive evaluation includes setting goals in partnership with the patient and usually a care partner; obtaining information about the patient’s risk profile for AD or a related disease (e.g., age, family history of dementia, hypertension, smoking); describing the history of symptoms and their impact on daily life; evaluating the patient’s ability to perform tests of thinking abilities; and obtaining a brain MRI or CT scan along with laboratory tests for conditions that may contribute to cognitive impairment. The integration of new brain scans, spinal fluid tests, or other specialized tests into this comprehensive evaluation will add critical value to the diagnostic formulation and care plan for persons in whom there is a clinical concern for AD or an ADRD.

A special issue of the journal Alzheimer’s & Dementia: The Journal of the Alzheimer’s Association highlights the new Alzheimer’s Association Clinical Practice Guideline for the Diagnostic Evaluation, Testing, Counseling and Disclosure of Suspected Alzheimer’s Disease and Related Disorders (DETeCD-ADRD CPG) that summarizes the process of diagnostic evaluation and disclosure for persons suspected of potentially having cognitive-behavioral impairment due to AD or ADRD. ADRDs include Lewy Body Disease, Frontotemporal Lobar Degeneration, Vascular Cognitive Impairment and Dementia (VCID), and a host of other diseases and conditions that may cause or substantially contribute to cognitive-behavioral impairment. Similar American guidelines are more than 20 years old and aimed at specialists or dementia subspecialists.

“With this guideline, we expand the scope of prior guidelines by providing recommendations for practicing clinicians on the process from start to finish,” said Brad Dickerson, M.D., Director of the Massachusetts General Hospital Frontotemporal Disorders Unit and Professor of Neurology at Harvard Medical School. “We recommend that medical professionals begin by making sure their thinking about the goals of the evaluation aligns with that of the patient, which usually requires a discussion to educate the patient on the specific steps of the process. Then we outline the steps involved in obtaining information about symptoms and examination, followed by a variety of diagnostic tests tailored to the patient, and summarize best practices regarding the diagnostic disclosure process.”

“We emphasize the importance of the involvement of a care partner throughout this process for most patients, since cognitive symptoms often compromise a person’s ability to process all of this information by themselves,” Dickerson added.

This guideline does not propose diagnostic or staging criteria for these diseases, which continue to evolve. Rather, it provides a framework for a high-quality process tailored to each individual patient that enables clinicians to establish a three-step diagnostic formulation including:

  • Cognitive Functional Status-the overall level of impairment, such as mild cognitive impairment or dementia.
  • Cognitive-Behavioral Syndrome- the symptoms the person is experiencing (e.g., progressive language difficulty and memory loss with depression).
  • The likely brain disease(s) or condition(s) causing the symptoms.

“The workgroup provides rigorous, evidence- and practice-informed foundational steps that capture the core elements of a high-quality evaluation and disclosure process,” Dickerson said. “The guidelines are formulated into 19 practical recommendations that are applicable to any practice setting, including primary care, along with additional guidance for specialists and subspecialists.”

In this special issue of Alzheimer’s & Dementia, the three executive summaries* by the DETeCD-ADRD CPG workgroup distill these recommendations, briefly summarize the evidence supporting them, and operationalize them as a series of steps in an evaluation process. A comprehensive report hosted online provides extensive details about the guideline development methodology, evidence review process, peer review process, rationale and recommendations for implementation, and specific narratives with evidence supporting each recommendation.

“The AD/ADRD field has entered a new era and is moving rapidly, which is very exciting,” said Alireza Atri, M.D., Ph.D., Chief Medical Officer, Banner Research, and Director of the Banner Sun Health Research Institute, Banner Health, Sun City and Phoenix, Arizona, and Lecturer on Neurology, Brigham and Women’s Hospital and Harvard Medical School. “This first U.S. interdisciplinary national evaluation guideline, designed for broad clinical settings, provides a comprehensive foundation summarizing a high-quality and personalized process within which specific tests are slotted and can be updated as the field evolves.”

“Some details of the guideline will likely require modification as new tools and biomarkers become sufficiently validated for appropriate clinical use in real-world practice. The workgroup leveraged best evidence and practices to empower persons with memory or thinking symptoms or concerns and their loved ones, clinicians, and health systems, to engage in a person-centered process that will enhance knowledge, appreciation and autonomy for the person with a potential illness — and facilitate doing what is right for them,” Atri said.

The DETeCD-ADRD CPG workgroup includes experts from multiple disciplines and multiple care settings, including primary care and specialty care. The guideline concludes that if clinicians use the recommendations in this guideline and health care systems provide adequate resources, outcomes should improve in most patients in most practice settings.

“We encourage clinicians to review these guidelines and incorporate them into their practice,” said Maria C. Carrillo, Ph.D., Alzheimer’s Association chief science officer and medical affairs lead. “These guidelines are important because they guide clinicians in the evaluation of memory complaints, which could have many underlying causes. That is the necessary start for an early and accurate Alzheimer’s diagnosis. In addition, these guidelines provide clinicians information about other underlying causes that may contribute to the memory complaints.”

Reference:

The Alzheimer’s Association Clinical Practice Guideline for the Diagnostic Evaluation, Testing, Counseling and Disclosure of Suspected Alzheimer’s Disease and Related Disorders (DETeCD-ADRD): Executive Summary of Recommendations for Primary Care,” Atri, et al. https://doi.org/10.1002/alz.14333

“The Alzheimer’s Association Clinical Practice Guideline for the Diagnostic Evaluation, Testing, Counseling and Disclosure of Suspected Alzheimer’s Disease and Related Disorders (DETeCD-ADRD): Executive Summary of Recommendations for Specialty Care,” Dickerson, et al. https://doi.org/10.1002/alz.14337

“The Alzheimer’s Association Clinical Practice Guideline for the Diagnostic Evaluation, Testing, Counseling and Disclosure of Suspected Alzheimer’s Disease and Related Disorders (DETeCD-ADRD): Validated Clinical Assessment Instruments,” Atri, et al. https://doi.org/10.1002/alz.14335

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Acetabular Dysplasia Linked to Increased Risk of Hip Osteoarthritis in Women and Older Adults: Research Suggests

Netherlands: A meta-analysis of data from over 18,000 hips revealed that acetabular dysplasia (AD) significantly raises the risk of developing radiographic hip osteoarthritis (RHOA) over a 4-8-year period. Hips with AD exhibited 1.8 times greater odds of progressing to RHOA compared to non-AD hips. The risk was notably higher among women, individuals aged 61-70, and those with a BMI under 25.

The findings, published in the journal Osteoarthritis and Cartilage, highlight the importance of monitoring individuals with AD for potential progression to osteoarthritis to enable early intervention and management.

Hip osteoarthritis (OA) has no curative nonsurgical treatment, making prevention vital. However, understanding risk factors for radiographic hip OA (RHOA) remains limited. Subtle hip shape abnormalities, such as acetabular dysplasia, may precede OA development and represent potential targets for prevention. AD, characterized by insufficient coverage of the femoral head by the acetabulum, leads to mechanical cartilage stress and may contribute to OA progression. Previous studies suggest an association between AD and RHOA, but inconsistencies and limited statistical power have hindered conclusive evidence.

Against the above background, Noortje S. Riedstra, Erasmus Medical Center, the Netherlands, and colleagues aimed to explore the relationship between various radiographic definitions of AD and incident RHOA, including subgroup analyses.

For this purpose, the researchers selected hips free of RHOA at baseline with a follow-up period of 4–8 years from the World COACH consortium. They calculated the Wiberg center edge angle (WCEA), acetabular depth width ratio (ADR), and modified acetabular index (mAI) to assess acetabular dysplasia. AD was defined as WCEA ≤ 25°, with secondary analyses using thresholds such as WCEA ≤ 20°, ADR ≤ 250, mAI ≥ 13°, and their combinations.

A logistic regression model with generalized mixed effects (3 levels) was applied, adjusting for age, biological sex, and body mass index (BMI). Descriptive statistics were reported stratified by age, sex, and BMI.

Key Findings:

  • The analysis included a total of 18,807 hips from 9 studies. Baseline characteristics included an average age of 61.84 years (± 8.32), a mean BMI of 27.40 kg/m² (± 4.49), and 70.1% of women.
  • Of the hips studied, 4766 hips (25.3%) had WCEA ≤ 25°.
  • During a follow-up period of 4–8 years (mean 5.8 ± 1.6), 378 hips (2.0%) developed incident RHOA.
  • There was an association between acetabular dysplasia and the development of RHOA (adjusted OR [aOR] 1.80).
  • Secondary analyses confirmed that all other definitions of AD were also associated with incident RHOA, with aOR values ranging from 1.52 to 1.96.
  • Descriptive statistics indicated a higher relative risk (RR) of developing RHOA in AD hips compared to non-AD hips in the following groups:
    • Age group 61–70 (RR 1.70)
    • BMI < 25 (RR 1.66)
    • Female hips (RR 1.73)

“Our study confirmed that acetabular dysplasia is a significant risk factor for the development of incident radiographic hip osteoarthritis (RHOA) in hips free of RHOA at baseline. Through an individual participant data (IPD) meta-analysis with large sample size, uniform AD measurements across radiographs, and a standardized RHOA outcome, the study provided a robust evaluation of the AD-RHOA association,” the authors wrote.

They emphasized that identifying modifiable risk factors like AD is critical for preventing hip osteoarthritis, improving quality of life, and advancing individualized care and the development of targeted treatments in the future.

Reference:

Riedstra NS, Boel F, van Buuren MMA, Ahedi H, Arbabi V, Arden N, Baart S, Bierma-Zeinstra S, Cicuttini F, Cootes TF, Crossley KM, Felson D, Giellis WP, Heerey J, Jones G, Kluzek S, Lane NE, Lindner C, Lynch JA, van Meurs JBJ, Mosler A, Nelson AE, Nevitt M, Oei E, Runhaar J, Tang J, Weinans H, Agricola R. Acetabular dysplasia and the risk of developing hip osteoarthritis within 4-8 years; an individual participant data meta-analysis of 18,807 hips from the World COACH consortium. Osteoarthritis Cartilage. 2024 Dec 8:S1063-4584(24)01479-1. doi: 10.1016/j.joca.2024.12.001. Epub ahead of print. PMID: 39657871.

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Pregnancy Vitamin D Supplementation Linked to Better Bone Health in Children: Study Finds

UK: A recent randomized controlled trial has highlighted the potential benefits of vitamin D supplementation during pregnancy, showing its positive impact on offspring bone health in mid-childhood. The findings suggest that mothers taking cholecalciferol (1000 IU/day) during pregnancy had children with higher bone mineral density (BMD) and greater lean mass compared to those whose mothers received a placebo.

The findings from the exploratory post-hoc analysis, published in The American Journal of Clinical Nutrition, indicate a clear association between maternal cholecalciferol use and improved bone health outcomes in their children.

Bone mineral density is a key marker of bone strength and overall skeletal health, and the research suggests that sufficient vitamin D during pregnancy could serve as a public health strategy to combat childhood bone-related disorders. Vitamin D plays a vital role in calcium absorption, which is critical for developing strong and healthy bones.

The Maternal Vitamin D Osteoporosis Study (MAVIDOS) trial provided evidence that gestational cholecalciferol supplementation positively influenced offspring bone mineral density (BMD) at age 4. Establishing whether this effect persists into later childhood is essential to determine if maternal vitamin D supplementation could be an effective public health strategy for improving long-term bone health. To this end, Rebecca J Moon, MRC Lifecourse Epidemiology Centre, University of Southampton, Southampton General Hospital, Tremona Road, Southampton, United Kingdom, and colleagues explored whether gestational vitamin D supplementation leads to increased offspring BMD at ages 6–7 years through a post-hoc analysis of data from the existing trial.

In the MAVIDOS randomized controlled trial, pregnant women under 14 weeks of gestation with singleton pregnancies and serum 25-hydroxyvitamin D levels between 25–100 nmol/L at three UK hospitals (Southampton, Sheffield, and Oxford) were randomly assigned to receive either 1000 IU/day cholecalciferol or a placebo. This supplementation began between 14 and 17 weeks of gestation and continued until delivery. Children born at term to mothers recruited in Southampton were invited to participate in the childhood follow-up at ages 4 and 6–7 years.

The children underwent dual-energy X-ray absorptiometry (DXA, Hologic Discovery) scans of the whole body excluding the head (WBLH) and lumbar spine. Measurements assessed bone area, bone mineral content (BMC), bone mineral density (BMD), and bone mineral apparent density (BMAD). Linear regression analysis was applied to compare the two groups while adjusting for potential confounding factors such as age, sex, height, weight, duration of breastfeeding, and vitamin D use at ages 6–7 years.

The analysis uncovered the following findings:

  • A total of 454 children were followed up at ages 6–7 years, with 447 having a usable DXA scan.
  • Gestational cholecalciferol supplementation was associated with higher whole-body less head bone mineral content (WBLH BMC), bone mineral density (BMD), bone mineral apparent density (BMAD), and lean mass compared to the placebo group.
  • Specifically, WBLH BMC was 0.15 SD higher, BMD was 0.18 SD higher, and BMAD was 0.18 SD higher. Additionally, lean mass was 0.09 SD higher in the cholecalciferol group.
  • The effects of gestational cholecalciferol supplementation on bone outcomes were consistent at ages 4 and 6–7.

“We showed that pregnant women who took 1000 IU/day of cholecalciferol during pregnancy showed higher offspring bone mineral density (BMD) and lean mass in mid-childhood compared to those who received a placebo, according to an exploratory post-hoc analysis,” the researchers wrote.

“These findings highlight that vitamin D supplementation during pregnancy could serve as a key public health strategy to enhance bone health in children,” they concluded.

Reference:

Moon RJ, D’ Angelo S, Curtis EM, Ward KA, Crozier SR, Schoenmakers I, Javaid MK, Bishop NJ, Godfrey KM, Cooper C, Harvey NC; MAVIDOS Trial Group. Pregnancy vitamin D supplementation and offspring bone mineral density in childhood follow-up of a randomized controlled trial. Am J Clin Nutr. 2024 Nov;120(5):1134-1142. doi: 10.1016/j.ajcnut.2024.09.014. Epub 2024 Sep 19. PMID: 39306330; PMCID: PMC11600048.

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Thoracentesis via wall suction as good as gravity drainage for procedural discomfort and dyspnea improvement, suggests study

Researchers have found that both wall suction and gravity drainage led to equivalent amounts of procedural chest pain and improvement in dyspnea among patients undergoing large-volume thoracentesis. A recent study was conducted by Samira S. and colleagues published in the journal Chest. Thoracentesis is a procedure to remove excess fluid from the pleural space and is frequently performed to help relieve symptoms such as breathlessness in patients suffering from pleural effusions.

Although previous studies showed no difference in procedural discomfort between manual aspiration and gravity drainage, the effect of wall suction drainage on chest discomfort has not been adequately addressed. This study aimed to bridge this gap by comparing wall suction with gravity drainage regarding procedural discomfort and related outcomes in patients with large free-flowing effusions.

This was a multicenter, single-blinded, randomized controlled trial that involved 228 patients, of whom 221 completed the study. Patients had large free-flowing pleural effusions of ≥ 500 mL and were randomly assigned at a 1:1 ratio to wall suction or gravity drainage.

  • Wall suction drainage: The technique involved a suction system with vacuum pressure set at full vacuum.

  • Gravity drainage: Carried out with a drainage bag located 100 cm caudal to the site of catheter insertion, connected via straight tubing.

Pain assessment was performed using a 100-mm VAS at preprocedure, during the procedure, and postprocedure. The main outcome measured was postprocedural chest pain at 5 minutes; other outcomes included pain, relief from dyspnea, procedure time, volume aspirated, and complications including pneumothorax and reexpansion pulmonary edema.

Key Findings

Chest Pain:

  • Procedural chest discomfort at 5 minutes was not significantly different between the wall suction and gravity drainage groups (p=0.08).

Dyspnea Relief:

  • No significant differences in dyspnea improvement were noted between the groups.

Procedure Time:

  • Gravity drainage took approximately 3 minutes longer than wall suction.

Fluid Volume:

  • Similar volumes of fluid were drained in both groups.

Safety:

  • The rates of pneumothorax and reexpansion pulmonary edema were matched between the groups, giving no evidence that either poses additional risk.

Thoracentesis performed using wall suction or gravity drainage resulted in similar levels of procedural chest discomfort, dyspnea improvement, and complication rates. The findings highlight the equivalence of these methods, allowing clinicians to tailor procedural techniques to individual patient needs and clinical settings.

Reference:

Shojaee, S., Pannu, J., Yarmus, L., Fantin, A., MacRosty, C., Bassett, R., Jr, Debiane, L., DePew, Z. S., Faiz, S. A., Jimenez, C. A., Avasarala, S. K., Vakil, E., DeMaio, A., Bashoura, L., Keshava, K., Ferguson, T., Adachi, R., Eapen, G. A., Ost, D. E., … Grosu, H. B. (2024). Gravity- vs wall suction-driven large-volume thoracentesis. Chest, 166(6), 1573–1582. https://doi.org/10.1016/j.chest.2024.05.046

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FDA Approves First Generic of Once-Daily GLP-1 Injection to Lower Blood Sugar in Diabetes patients

The U.S. Food and Drug Administration approved the first generic referencing Victoza (liraglutide injection) 18 milligram/3 milliliter, a glucagon-like peptide-1 (GLP-1) receptor agonist indicated to improve glycemic control in adults and pediatric patients aged 10 years and older with type 2 diabetes as an adjunct to diet and exercise.

The FDA approved the first generic in this class of medications last month with the approval of a generic referencing Byetta (exenatide).

Liraglutide injection and certain other GLP-1 medications are currently in shortage. The FDA prioritizes assessment of generic drug applications for drugs in shortage to help improve patient access to these medications.

“The FDA supports development of complex generic drugs, such as GLP-1s, by funding research and informing industry through guidance as part of our ongoing efforts to increase access to needed medications,” said Iilun Murphy, M.D., director of the Office of Generic Drugs in the FDA’s Center for Drug Evaluation and Research. “Generic drugs provide additional treatment options which are generally more affordable for patients. Today’s approval underscores the FDA’s continued commitment to advancing patient access to safe, effective and high-quality generic drug products.”

Type 2 diabetes is a chronic condition that occurs when the body does not use insulin well and cannot keep blood sugar at normal levels. It develops over many years and is usually diagnosed in adults, but has been increasingly diagnosed in children, teens and young adults.

Liraglutide improves blood sugar levels by creating similar effects in the body as GLP-1 in the pancreas, which is often found in insufficient levels in type 2 diabetes patients. According to the Centers for Disease Control and Prevention, more than 38 million Americans have diabetes, and 90% to 95% of those individuals have type 2 diabetes.

The prescribing information for the generic liraglutide injection approved today includes a Boxed Warning to advise health care professionals and patients about the increased risk of thyroid C-cell tumors. For this reason, patients who have had, or have family members who have ever had medullary thyroid carcinoma should not use liraglutide, nor should patients who have an endocrine system condition called multiple endocrine neoplasia syndrome type 2. In addition, people who have a prior serious hypersensitivity reaction to liraglutide or any of the product components should not use liraglutide. Liraglutide also carries warnings about pancreatitis, liraglutide pen sharing, hypoglycemia when used in conjunction with certain other drugs known to cause hypoglycemia including insulin and sulfonylurea, renal impairment or kidney failure, hypersensitivity and acute gallbladder disease. The most common side effects reported in the clinical trials for liraglutide injection include nausea, diarrhea, vomiting, decreased appetite, dyspepsia and constipation.

Addressing the challenges related to developing generics and promoting more generic competition is a key part of the FDA’s Drug Competition Action Plan and the agency’s efforts to help increase patient access to medicines.

The development of complex drug products such as liraglutide can be more difficult due to their complex active ingredient, formulation or mode of delivery. As a result, many complex drugs lack generic competition. To address this issue and facilitate timely development and approval of needed medications, particularly complex products, the FDA works to clarify regulatory expectations for applicants early in the development process, including through guidance for industry and the pre-ANDA program. These efforts make it more feasible for manufacturers to develop generic drugs and can enhance patient access to treatment by helping make these products more available, allowing patients in the United States to obtain the medicines they need.

The FDA granted the approval of generic liraglutide injection to Hikma Pharmaceuticals USA Inc.

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Prenatal substance use may increase sudden unexpected infant death risks through unsafe sleep practices: Study

A recent study used data from the Sudden Death in the Young Registry and highlighted the startling link between maternal substance use during pregnancy and increased risks of sudden unexpected infant death (SUID), particularly through unsafe sleep environments and social vulnerabilities. After analyzing cases from 2015 to 2020, the study published in the Pediatrics journal identified critical differences in sleep-related SUID among infants who were prenatally exposed to substances when compared to the ones not exposed.

Of the 2,010 infant sleep-related deaths studied, 283 (14%) involved infants exposed to substances prenatally. The data revealed that more than half of all deaths occurred in hazardous sleep environments, such as adult beds (52%) or when surface sharing with adults (53%). These risks were disproportionately higher among infants with prenatal substance exposure by suggesting the need for targeted prevention measures.

One of the most concerning findings was the impairment of supervisors at the time of infant death. Among prenatally exposed cases, 34% of supervisors were impaired (e.g., under the influence of drugs or alcohol) when compared to 16% of non-exposed cases. This points to the necessity of support systems to ensure safe infant care during periods when parents or caregivers might be unable to provide attentive supervision.

Beyond the immediate sleep environment, the study also identified stark social vulnerabilities contributing to these outcomes. Families impacted by prenatal substance use were significantly more likely to undergo barriers such as limited access to health care, involvement with child welfare systems, intimate partner violence, and inadequate insurance coverage. These factors collectively exacerbate the risks of unsafe sleep practices and SUID. 

The study emphasize that addressing these disparities requires a two-pronged approach, one being the targeted safe sleep education and the other by tackling the underlying social determinants of health. Safe sleep messaging should focus on discouraging adult bed-sharing and surface sharing, along with promoting the use of cribs or bassinets for infants. Support systems must be engaged to assist families during periods of impairment.

Also, the structural support is crucial where the families must have improved access to health care, safe sleep materials (like cribs), and interventions to reduce social vulnerabilities like addressing intimate partner violence and ensuring stable insurance coverage. Overall, this study brings out the importance of tailoring prevention efforts to meet the unique needs of substance-affected families.

Reference:

Deutsch, S. A., Loiselle, C. E., Hossain, J., & De Jong, A. (2024). Sleep-Related Sudden Unexpected Infant Death Among Infants Prenatally Substance Exposed. In Pediatrics. American Academy of Pediatrics (AAP). https://doi.org/10.1542/peds.2024-067372

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12 questions to ask for better brain health in 2024

Improving your brain health in the new year can start with a simple step, talking with your neurologist or primary care physician about 12 factors to protect your brain. The factors are outlined in an Emerging Issues in Neurology article developed by the American Academy of Neurology and published in the online issue of Neurology.

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More blood transfusions linked to lower 6-month mortality in heart-attack patients with anemia

Giving more blood to anemic patients after a heart attack may save lives, according to a Rutgers Health–led study. The study, published in NEJM Evidence, affirms research conducted in 2023 that suggested mortality rate or recurrent heart attacks were more frequent in anemic patients who received less blood.

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