Common pregnancy complications may be a signal of future stroke risk, reveals study

Women who experience complications during pregnancy face a higher risk of stroke in the following decades according to research published in the European Heart Journal. 

The study, which included data on more than two million women over more than 40 years, found an increased risk for women who had diabetes or high blood pressure while pregnant, a preterm delivery or a baby with a low birth weight.

Researchers say these common pregnancy complications could act as an early signal for cardiovascular problems in the future, meaning women could receive help early in life to lower their risk of stroke.

A stroke happens when the blood supply to part of the brain is cut off, starving brain cells of oxygen and leading to possible cognitive and physical disabilities.

The study was led by Professor Casey Crump from the Department of Family & Community Medicine at UTHealth Houston, USA. He said: “We know that pregnancy is a ‘natural stress test’ that may reveal higher cardiovascular disease risks long before cardiovascular disease actually develops.

“Up to one-third of all pregnancies are affected by one of these complications. However, the long-term cardiovascular risks for these women remain poorly understood and so are often not considered in their routine clinical care.”

The researchers used data from a Swedish national cohort of all 2,201,393 singleton pregnancies between 1973 and 2015. Around 30% of the women (667,774) experienced at least one of the following complications: preterm delivery (less than 37 weeks), a baby born small for their gestational age (among the smallest 10%), high blood pressure during pregnancy including preeclampsia (dangerously high blood pressure) and pregnancy diabetes (high blood sugar).

Researchers also gathered data on which women went on to experience a stroke in the following years up to 2018 and compared rates of strokes between women who had pregnancy complications and women who did not.

The risk of stroke was almost doubled for women who had high blood pressure (not preeclampsia) or high blood sugar during pregnancy. For women who had a preterm delivery, the risk of stroke was around 40% higher, for women with preeclampsia, the risk was around 36% higher, and for women whose babies were born small for their gestational age, the risk was around 26% higher. Risks were even greater in women who experienced two or more of these complications.

The increased risks were generally highest in the first 10 years after delivery but continued throughout the women’s lives even 30 to 46 years after pregnancy. However, for women who had pregnancy diabetes, the increased risk became even higher over time.

The researchers also compared the risk of stroke between sisters in the cohort, who share similar genetic and environmental risk factors for stroke, but they found that this did not fully account for the link between complications during pregnancy and the risk of stroke.

Professor Crump said: “To our knowledge, this study is the largest ever to examine multiple pregnancy complications in relation to long-term stroke risks in the same cohort of women. Also, it is the first to assess whether families might share factors that predispose both to adverse pregnancy outcomes and stroke, but shared familial factors did not appear to explain our findings.

“These pregnancy complications share some common features, including placental abnormalities and inflammation, that may potentially affect the structure or function of small blood vessels. Those changes in the small blood vessels sometimes progress further after pregnancy, and this could be one factor in the women’s higher risk of stroke.

“Both women and their doctors should now recognise that pregnancy complications are an early signal for future stroke risk. This can help us identify high-risk women long before they suffer a stroke or other cardiovascular disease. Women who experience these complications need support to reduce other cardiovascular risk factors, including obesity, physical inactivity, unhealthy diet, smoking, high blood pressure, diabetes, and high cholesterol. These interventions should be implemented as early as possible, followed by long-term monitoring to reduce their stroke risk across the life course.”

In an accompanying editorial [2] Dr Abbi Lane from the University of Michigan, USA, said: “Stroke is a major cause of death and disability that may be preceded by distinct risk factors in women vs. men. Understanding earlier life, sex-specific stroke risk factors can help identify high-risk individuals who can be targeted for preventive intervention. The study presented in this issue of European Heart Journal by Crump and colleagues addressed this critical need by rigorously defining the associations between adverse pregnancy outcomes (APOs) and stroke. APOs were not rare; 30% of women had experienced at least one APO. All APOs were significantly associated with stroke over 46 years of follow-up.

“Perhaps more attention should be paid to the psychological and emotional toll associated with APOs. Not only does the complicated pregnancy/birth itself cause stress, but the psychological and/or medical sequelae of the APO can last for months or years. Managing medical and neurodevelopmental disorders can lead to months or years of emotional, logistical, and financial strain for parents.

“Effects of psychosocial stress may manifest to eventual stroke via two potentially overlapping pathways: direct physiological effects and poor coping behaviours. There are direct physiological

responses to stress that are also early events in the development of overt stroke risk factors. High stress is linked to unfavourable effects on lifestyle and coping behaviours, including

smoking, worse medication adherence, poor diet, low physical activity, and higher body weight.

“Interrupting the cascade from APO to stroke might involve a multifaceted approach to control blood pressure and address modifiable lifestyle habits that influence physical and mental health soon after APOs.

“As APOs occur in ∼30% of parous people and stroke is ∼90% preventable, implementing a multicomponent, preventive intervention aimed at modifiable stroke risk factors soon after delivery seems like an obvious win.”

Reference:

Casey Crump, Adverse pregnancy outcomes and long-term risk of stroke: a Swedish nationwide co-sibling study, European Heart Journal, ttps://doi.org/10.1093/eurheartj/ehaf366

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Early Childhood BMI Changes may increase non allergic Asthma Risk among boys: Study

Researchers have found in a new study that changes in Body Mass Index (BMI) during early childhood may significantly affect asthma risks. Specifically, boys with increasing BMI have a higher risk of non-allergic asthma (NA), while girls with consistently high BMI are more likely to develop allergic asthma (AA).

Few studies have explored the relationship between changes in body mass index(BMI) during early childhood and asthma prevalence divided by phenotypes and sex, and the limited results are conflicting. This study assessed the impact of BMI changes during early childhood on school‐age asthma, classified by phenotypes and sex, using a nationwide longitudinal survey in Japan. From children born in 2001 (n = 47,015), we divided participants into BMI quartiles (Q1, Q2, Q3, and Q4) and the following BMI categories: Q1Q1 (i.e., Q1 at birth and Q1 at age 7), Q1Q4, Q4Q1, Q4Q4, and others. Asthma history from ages 7 to 8 was analyzed, with bronchial asthma (BA) further categorized as allergic asthma (AA) or nonallergic asthma (NA) based on the presence of other allergic diseases. Using logistic regression, we estimated the asthma odds ratio (OR) and 95% confidence intervals (CIs) for each BMI category. Results: Q1Q4 showed significantly higher risks of BA, AA, and NA. In boys, BA and NA risks were significantly higher in Q1Q4 (adjusted OR: 1.47 [95% CI: 1.17–1.85], at 1.56 [95% CI: 1.16–2.1]), with no significant difference in AA risk. In girls, no increased asthma risk was observed in Q1Q4, but AA risk was significantly higher in Q4Q4 (adjusted OR: 1.78 [95% CI: 1.21–2.6]). The results demonstrated that BMI changes during early childhood impact asthma risks, particularly that the risk of NA in boys increases with BMI changes during early childhood, and the risk of AA in girls increases with consistently high BMI.

Reference:

Yabuuchi T, Ikeda M, Matsumoto N, Tsuge M, Yorifuji T, Tsukahara H. Changes in body mass index during early childhood on school-age asthma prevalence classified by phenotypes and sex. Pediatr Int. 2025 Jan-Dec;67(1):e70090. doi: 10.1111/ped.70090. PMID: 40457851; PMCID: PMC12130911.

Keywords:

Early, Childhood, BMI, Changes, may, increase, non allergic, Asthma, Risk, among, boys, Study, asthma, body mass index, child, phenotypes, sex, Yabuuchi T, Ikeda M, Matsumoto N, Tsuge M, Yorifuji T, Tsukahara H

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SGLT2 Inhibitors Linked to Higher Risk of Euglycemic Ketoacidosis after Surgery : JAMA

A study published in JAMA Surgery involving nearly 500,000 surgeries among U.S. veterans found that patients taking SGLT2 inhibitors faced a small but significant increase in the risk of euglycemic ketoacidosis after surgery. However, these patients also experienced lower rates of acute kidney injury and 30-day mortality.

Case reports and small retrospective studies have suggested that there is an increased risk of postoperative euglycemic ketoacidosis (eKA) and acute kidney injury (AKI) among patients using sodium-glucose cotransporter 2 inhibitors (SGLT2i) preoperatively. However, there has not been a representative assessment of the risks of these agents among patients undergoing surgery. A study was done to evaluate the risk of postoperative eKA, AKI, and mortality within 30 days after surgery among preoperative long-term SGLT2i users compared with nonusers. This is a multicenter, propensity-matched, retrospective case-control study from the Veterans Affairs Health Care System (VAHCS) National Registry performed from January 1, 2014, to December 31, 2022. Adult patients using SGLT2i preoperatively who underwent inpatient surgical procedures were compared with a 1:5 matched control group using propensity score matching, including the patient’s demographic characteristics, comorbidities, and surgical characteristics. Data analysis was performed from June 2023 to August 2024. Long-term use of SGLT2i, defined as having more than 3 fills of outpatient prescription or less than a 180-day gap of the last fill according to the VAHCS pharmacy registries. The primary outcome was the rate of postoperative eKA among SGLT2i users vs control patients. Secondary outcomes included postoperative AKI and 30-day mortality after surgery. Results Among 462 968 patients undergoing surgery, 7448 SGLT2i users (mean [SD] age, 67.7 [8.1] years; 7204 [96.7%] male) and 455 520 nonusers (mean [SD] age, 65.8 [11.0] years; 424 785 [93.3%] male) were identified. After propensity score matching, 7439 patients were identified as SGLT2i users and compared with 33 489 control patients. SGLT2i use was associated with an increased risk of eKA (odds ratio [OR], 1.11; 95% CI, 1.05-1.17) but reduced risks of perioperative AKI (OR, 0.69; 95% CI, 0.62-0.78) and 30-day mortality (OR, 0.70; 95% CI, 0.55-0.88). The mortality rate 30 days after surgery was 1.1% among SGLT2i users vs 1.6% among control patients. The median hospital length of stay among the patients presenting with eKA increased by 3 days (median [IQR], 6 [3-10] days for those with eKA vs 3 [2-6] days for those without eKA). Patients treated with SGLT2i had a small but significantly higher risk of postoperative eKA but lower risks of postoperative AKI and 30-day mortality.

Reference:

Tallarico RT, Jing B, Lu K, et al. Postoperative Outcomes Among Sodium-Glucose Cotransporter 2 Inhibitor Users. JAMA Surg. Published online April 30, 2025. doi:10.1001/jamasurg.2025.0940

Keywords:

SGLT2, Inhibitors, Linked, Slightly, Higher, Risk, Euglycemic, Ketoacidosis, Post-Surgery, JAMA, Tallarico RT, Jing B, Lu K, Postoperative Outcomes, Among, Sodium-Glucose, Cotransporter 2, inhibitor Users

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Study Unraveles Impact of Maternal Hypertensive Disorders on Neurodevelopment in Preterm Infants

Recent study aimed to investigate the associations between maternal hypertensive disorders of pregnancy (HDP), particularly preeclampsia, and neurodevelopmental outcomes in preterm infants at 2 years’ corrected age. A regional prospective cohort study of 395 preterm infants born at Յ32 weeks’ gestation was conducted. The main outcomes measured were structural brain magnetic resonance imaging at term-equivalent age and neurodevelopmental assessment using the Bayley Scales of Infant and Toddler Development (BSID), Third Edition, between 22 and 26 months’ corrected age. Preeclampsia affects 2% to 5% of pregnancies and is linked to premature birth and neurodevelopmental deficits due to disruptions in fetal brain development. Hypertensive disorders of pregnancy, including preeclampsia, impact 5% to 15% of pregnancies and share similar mechanisms with preeclampsia that can affect brain development, leading to cognitive, motor, and behavioral issues in children. While HDP exposure has been associated with suboptimal neurodevelopmental outcomes in full-term infants, findings in preterm infants have been inconsistent, with some studies showing worse outcomes, while others suggest a protective role.

Neurodevelopmental Outcomes

In the cohort of preterm infants, HDP-exposed infants had lower cognitive and language scores on the BSID at 2 years’ corrected age. Preeclampsia-exposed infants showed greater reductions in scores. Mediation analyses revealed that brain abnormalities partially mediated the effect of HDP on lower cognitive scores. Adjusting for histologic chorioamnionitis, a risk factor for preterm birth and adverse neurodevelopmental outcomes, was crucial in this study.

Study Strengths and Recommendations

The study’s strengths included population representation, precise exposure, and outcome assessments, standardized brain MRI scoring, and rigorous confounder control. Notably, the study highlighted the importance of addressing biases from inadequate adjustment of confounders and inappropriate adjustment of intermediate variables in previous research. The findings underscored the need for closer monitoring and early interventions in HDP-exposed preterm infants to improve long-term outcomes. Understanding the mechanisms through which HDP affects neurodevelopment, such as its impact on early brain development, is crucial for refining risk stratification and enhancing early identification of developmental delays for targeted interventions. Enhanced efforts to prevent or treat maternal hypertension may help reduce the risk of abnormal brain development and neurodevelopmental deficits in preterm infants.

Key Points

– The study aimed to investigate the associations between maternal hypertensive disorders of pregnancy (HDP), particularly preeclampsia, and neurodevelopmental outcomes in preterm infants at 2 years’ corrected age. Preeclampsia is linked to premature birth and neurodevelopmental deficits due to disruptions in fetal brain development.

– HDP exposure in preterm infants was associated with lower cognitive and language scores on the Bayley Scales of Infant and Toddler Development (BSID) at 2 years’ corrected age, with more significant reductions in scores observed in preeclampsia-exposed infants.

– Brain abnormalities partially mediated the effect of HDP on lower cognitive scores in preterm infants. Adjusting for histologic chorioamnionitis, a risk factor for adverse neurodevelopmental outcomes, was crucial in the analysis.

– The study emphasized the importance of population representation, precise exposure and outcome assessments, standardized brain MRI scoring, and rigorous confounder control. It highlighted the need to address biases in previous research related to inadequate adjustment of confounders and inappropriate adjustment of intermediate variables.

– Early monitoring and interventions are recommended for HDP-exposed preterm infants to improve long-term outcomes. Understanding the mechanisms through which HDP affects neurodevelopment, particularly its impact on early brain development, is crucial for risk stratification and early identification of developmental delays.

– Preventing or treating maternal hypertension may help reduce the risk of abnormal brain development and neurodevelopmental deficits in preterm infants. Efforts in this direction could lead to improved outcomes for preterm infants exposed to hypertensive disorders during pregnancy.

Reference –

Shipra Jain et al. (2025). Maternal Hypertension And Adverse Neurodevelopment In A Cohort Of Preterm Infants. *JAMA Network Open*, 8. https://doi.org/10.1001/jamanetworkopen.2025.7788.

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Empagliflozin Not Linked to Increased Risk of Urinary Tract Cancers: Study

Empagliflozin use in patients with type 2 diabetes (T2D) has not been shown to have a higher risk of urinary tract cancers (UTCs), such as bladder and renal cancers, compared to dipeptidyl peptidase-4 inhibitors (DPP-4i), according to researchers. The research provides reassurance about the cancer safety profile of empagliflozin, a widely prescribed sodium-glucose co-transporter 2 (SGLT2) inhibitor for the treatment of T2D. The study was published in Diabetes Obesity & Metabolism by Niklas S. and colleagues.

The research was a non-interventional, retrospective cohort study among adult patients with T2D who were new users of empagliflozin or DPP-4 inhibitors. The data covered the period between 2014 and 2020 in Sweden and Finland, and up to 2021 in the UK. A total of 151,055 propensity score-matched patients were contributed from the three nations. The analysis used an “as-treated” strategy and adopted a latency of 180 days after the first prescription to minimize confounding by the premature development of cancer.

The researchers calculated incidence rates (IRs) and hazard ratios (HRs) for UTCs by using Cox regression models that were controlled for age, sex, comorbidities, and other potential confounders. Random-effects meta-analysis was employed to combine results by country.

Results

  • The matched cohort consisted of 151,055 patients with T2D, the majority being female (between 59.6% and 67.8%), and the mean empagliflozin user’s age ranged between 57.0 and 63.2 years across countries.

The meta-analysis demonstrated:

  • There was no significant increase in total UTC risk among individuals using empagliflozin when compared to those using DPP-4i (adjusted HR = 0.88; 95% CI: 0.66–1.17).

  • Risk of bladder cancer was likewise unaffected (adjusted HR = 0.91; 95% CI: 0.63–1.33).

  • Risk for renal cancer was also not increased (adjusted HR = 0.89; 95% CI: 0.57–1.38).

In this multinational, large-scale cohort study, empagliflozin was not linked with a higher risk of urinary tract, bladder, or kidney cancers compared with DPP-4 inhibitors in adults with type 2 diabetes. The findings indicate the long-term safety of empagliflozin in terms of cancer risk and support its position in holistic diabetes management.

Reference:

Schmedt, N., Alhamdow, A., Tskhvarashvili, G., Saarelainen, L., Qiao, X., Lobier, M., & Hoti, F. (2025). Post-authorisation safety study to assess the risk of urinary tract cancer in people with type 2 diabetes initiating empagliflozin: A multi-country European study. Diabetes, Obesity & Metabolism. https://doi.org/10.1111/dom.16477

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Health Ministry Plans Licence Suspension for Drugs Failing Quality Standards: Report

New Delhi: The Union Health Ministry is planning a regulatory overhaul that could result in the immediate suspension of product licenses for drugmakers whose products are declared not of standard quality (NSQ) by government testing laboratories.

The move, aimed at ensuring drug quality and public safety, is currently under discussion with various state regulators.

According to a recent media report in the Economic Times, the government intends to issue a notification soon, mandating swift punitive action against companies whose products fail quality tests. Discussions are also underway with stakeholders including state governments and pharmaceutical industry bodies.

The proposal comes in the backdrop of concerns over the rising number of NSQ alerts issued by the Central Drugs Standard Control Organisation (CDSCO). While the health ministry leads the initiative, the CDSCO is in active consultation with pharma associations that have expressed strong reservations about the proposed measures.

Earlier, the Drugs Technical Advisory Board (DTAB) — the apex advisory body on technical matters related to drugs under the CDSCO — had recommended the idea of prompt regulatory action in such cases. As per the official minutes of the board meeting:

“The board noted that it is very important that once a drug is declared NSQ, the license of such product shall be suspended immediately in public interest unless a satisfactory corrective action and preventive action (CAPA) is submitted by such manufacturers. After detailed deliberation, DTAB recommended for the appropriate amendment in the Drug Rules in this regard and the suspension product licence should be revoked only after root cause analysis and corresponding CAPA has been implemented.”

A senior government official, speaking to ET on condition of anonymity, added:

“The health ministry and the CDSCO is taking a step forward by taking views of the states and pharma bodies as it would require a notification.”

Also Read: Substandard Drugs to Face Immediate License Suspension Under DTAB’s New Recommendation

Meanwhile, industry groups have voiced concern over the draft approach. In its representation to the government, the Federation of Pharma Entrepreneurs (FOPE) argued that NSQ incidents are often not due to intentional wrongdoing but technical lapses.

“NSQ is a global phenomenon, and most of the time, it is due to technical issues without any wrongful intent,” FOPE stated.

Pharma associations also pointed to inconsistencies in test results from government labs and raised questions about GLP (Good Laboratory Practices) compliance.

“This has been a long-standing concern. It is also necessary that the NSQ investigation includes a review of records and data from government testing laboratories, as well as GLP compliance by the Drugs Inspector,” a member of one such group told ET.

“It has been found that in many cases, samples declared NSQ by government labs, when challenged and tested by CDL Kolkata, have been declared as Standard Quality by CDL Kolkata, which is an appellate laboratory,” the person added.

In addition to questioning the reliability of some NSQ assessments, drugmakers emphasized the need to focus on enhancing the recall mechanism rather than imposing automatic licence suspensions.

FOPE also cautioned the ministry to undertake a detailed impact analysis before finalising the proposal, noting the potential unintended consequences:

“We fear it may lead to malpractices in the profession, and genuine manufacturers with investments of hundreds of crores in plant setup, product development, technical team development, brand development, business development, and goodwill, may be adversely impacted if actions like the suspension of product permission are taken without proper investigation.”

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Physical Activity Reduces Gout Risk in Hyperuricemia Patients, Says Machine Learning Study

Using machine learning models researchers have found in a new study that increased physical activity and reduced sedentary time significantly lower the risk of developing gout in individuals with hyperuricemia.

Individuals with hyperuricemia (HUA) are widely recognized as being at increased risk for gout. This study aimed to investigate how physical activity (PA) duration and sedentary duration impact gout risk in individuals with HUA and to develop predictive models to assess their risk of developing gout. They retrospectively collected clinical characteristics of 8057 individuals with HUA from the National Health and Nutrition Examination Survey (NHANES) consortium for the period 2007–2018. By developing and comparing four classic machine learning algorithms, the best-performing Random Forest (RF) model was selected and combined with the SHAP interpreting algorithm to analyze the dose–response relationship between PA duration, sedentary time, and gout risk. Additionally, the RF model was used to identify the most critical factors influencing gout risk and to develop a free online tool for predicting gout risk in HUA individuals. Results: The RF model outperformed others, achieving a Receiver Operating Characteristic (ROC) of 0.957 in the training cohort and 0.799 in the testing cohort. In the test cohort, it demonstrated an accuracy of 0.778, a Kappa of 0.247, a sensitivity of 0.701, a specificity of 0.785, a positive predictive value of 0.224, a negative predictive value of 0.967, and an F1 score of 0.340. SHAP analysis revealed the following insights: (1) hypertension, serum uric acid, age, gender, and BMI were identified as the top five factors for gout risk; (2) factors such as higher serum uric acid levels, age, BMI, creatinine, sedentary duration, lower PA, hypertension, male sex, and diabetes were associated with an elevated risk of gout; and (3) a PA duration of 1–7 h per week was linked to a lower risk of gout, while sedentary time exceeding 6 h per day increased gout risk, regardless of age, sex, or comorbidities. They encourage individuals with HUA to engage in 1–7 h of PA per week and limit daily sedentary time to less than 6 h to reduce gout risk. The developed prediction model is freely available as a web-based app at: https://sasuki.shinyapps.io/GoutRisk/.

Reference:

Jiao, Y., Cheng, Z., Lan, Z., Kan, S. and Du, Y. (2025), Exploring the Impact of PA and Sedentary Behavior on Gout Risk in Hyperuricemia: Insights From Machine Learning and SHAP Analysis. Int J Rheum Dis, 28: e70238. https://doi.org/10.1111/1756-185X.70238

Keywords:

Physical, Activity, Reduces, Gout, Risk, Hyperuricemia, Patients, Says Machine, Learning, Study, International Journal of Rheumatic Diseases, Jiao, Y., Cheng, Z., Lan, Z., Kan, S. and Du, Y

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Bharat Serums Gets CDSCO Panel Nod for Phase III Trial of IVIG in Chronic ITP

New Delhi: Bharat Serums and Vaccines has received approval from the Subject Expert Committee (SEC) functional under the Central Drugs Standard Control Organisation (CDSCO) to conduct a Phase III clinical trial of Human Normal Immunoglobulin for Intravenous Use (IVIG) 5% Solution.

This came after the firm presented the revised protocol — updated as per the recommendations given by the committee during the SEC meeting held on February 11, 2025 — for the proposed Phase III clinical trial titled:

“An Open-Label, Multicenter, Phase III Clinical Study in India to Evaluate the Efficacy and Safety of Human Normal Immunoglobulin for Intravenous Use (IVIG) in Chronic Immune Thrombocytopenia (ITP)”, vide Protocol No. BSV_IVIG_ITP_2023_02, Version 4.0, dated April 17, 2025.

Human Normal Immunoglobulin for Intravenous Use (IVIG) 5% solution is a plasma-derived product containing primarily IgG antibodies, used to enhance immunity in individuals with immune deficiencies or autoimmune disorders. Administered intravenously, it helps the body fight infections and regulate immune responses.

At the recent SEC (Hematology) meeting held on June 10, 2025, the expert panel reviewed the revised protocol and, after detailed deliberation, “recommended the grant of permission to conduct the Phase III clinical trial as per revised Protocol No. BSV_IVIG_ITP_2023_02, Version 4.0 dated 17.04.2025.”

Also Read: Sun Pharma Gets Relief on Packaging Norms for Pantoprazole-Levosulpiride FDC

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SEC Clears Hemopurifier Device for Cancer Study in Indian Patients

New Delhi: In a step toward advancing medical device-based cancer care, the Subject Expert Committee (SEC) under the Oncology division of the Central Drugs Standard Control Organisation (CDSCO) has granted permission to conduct a pilot clinical investigation of the Hemopurifier device in India.

The proposal, submitted by Qualtran Consulting, was reviewed during the 19th SEC (Oncology) meeting held on 5th June 2025 at CDSCO headquarters, New Delhi.

The firm presented Study Protocol No. AEMD-2024-01-Oncology-India, dated 24th May 2024, a proposal for grant of permission to conduct Pilot Clinical Investigation on proposed medical device Hemopurifier in the country on Indian population before the committee.

After detailed deliberation the committee recommended for;

“The grant of permission to conduct of Pilot Clinical Investigation to prove safety and feasibility of the device in removing circulating exosomes of individuals with solid malignancies on Indian Population as per Study Protocol no. AEMD-2024-01-Oncology-India dated 24.05.2024.”

The Hemopurifier is a blood filtration medical device designed to selectively remove circulating exosomes and tumor-derived particles from the bloodstream. These components are known to play a role in tumor progression, immune evasion, and resistance to cancer therapies.

Also Read: 58 Drug Batches, Including Dexona Fail CDSCO Quality Standards

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AI in health care needs patient-centered regulation to avoid discrimination, say experts

A new commentary published in the Journal of the Royal Society of Medicine warns that current risk-based regulatory approaches to artificial intelligence (AI) in health care fall short in protecting patients, potentially leading to over- and undertreatment as well as discrimination against patient groups.

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