Breastfeeding Linked to Lower Risk of Early Puberty in Children, reports research

Breastfeeding within the first 4 to 6 months of life has been identified by researchers as being associated with a reduced risk of central precocious puberty (CPP) in children of both genders. CPP is the condition of early onset of puberty at an unnatural age, and it has been on the rise globally, triggering concerns about long-term consequences such as metabolic disorders, psychological distress, and enhanced risk of various diseases later in life. This study was published in JAMA Network Open by Yunsoo C. and colleagues.

It was a big retrospective cohort analysis that used data from the South Korean National Health Insurance Service Database from January 1, 2007, to December 31, 2020. There were 322,731 children who received regular health checkups at 4 to 6 months and once more at 66 to 71 months. Children with comorbidities, those who died during the follow-up period, those with missing data, or those diagnosed with CPP before age 6 years were excluded.

Infant feeding patterns were measured with caregiver-completed questionnaires during the 4–6-month visit. Children were categorized as being exclusively breastfed (46.0%), formula-fed (34.9%), or mixed-fed (19.1%). The main outcome was incidence of CPP, defined by diagnostic codes and verified with treatment with gonadotropin-releasing hormone agonists. Multivariable Cox proportional hazards models were applied to estimate adjusted hazard ratios (AHRs), and mediation analysis was conducted to test whether childhood overweight or obesity accounted for some of the association.

Results

  • The results indicated that the greatest risk of CPP was linked with formula feeding, followed by mixed feeding, relative to exclusive breastfeeding.

  • For boys, formula feeding raised the risk of CPP by 16% (AHR, 1.16; 95% CI, 1.10–1.21), whereas mixed feeding raised the risk by 14% (AHR, 1.14; 95% CI, 1.07–1.20).

  • The risks were even greater in girls. Formula feeding was linked to a 60% higher risk (AHR, 1.60; 95% CI, 1.24–2.06), and mixed feeding to a 45% higher risk (AHR, 1.45; 95% CI, 1.07–1.97).

  • Mediation analysis revealed that prepubertal adiposity mediated a part of the association. Excess weight in childhood explained 7.2% of the formula–CPP relationship in boys (bootstrap 95% CI, 4.5%–12.1%) and 17.8% in girls (bootstrap 95% CI, 6.6%–30.0%).

This large South Korean national study identified that sole breastfeeding during the first 4–6 months of life is linked to a reduced risk of central precocious puberty in both girls and boys, but formula feeding and mixed feeding were associated with much increased risks. Encouraging breastfeeding and the prevention of childhood obesity may be crucial in reducing the burden of early puberty.

Reference:

Choe Y, Ryu S, Choi J, et al. Breastfeeding, Prepubertal Adiposity, and Development of Precocious Puberty. JAMA Netw Open. 2025;8(8):e2527455. doi:10.1001/jamanetworkopen.2025.27455

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Sun Pharma Gets CDSCO Panel Nod for Phase IV Trial of Esomeprazole Dual Release Tablets 80 mg

New Delhi: Sun Pharma has received approval from the Subject Expert Committee (SEC), under the Central Drugs Standard Control Organisation (CDSCO), to conduct a Phase IV clinical trial of Esomeprazole Dual Release Gastro-resistant Tablets 80 mg, based on its revised study protocol.

According to the minutes of the 12th/25 SEC (Gastroenterology & Hepatology) meeting held on August 20, 2025, at CDSCO headquarters, the proposal was taken up under the SND Division.

In continuation with earlier SEC (Gastroenterology & Hepatology) recommendation dated 27/02/2025, the firm presented revised protocol for Phase-IV clinical trial of Esomeprazole Dual release gastro-resistant tablets 80 mg before the Committee.

The committee carefully examined the revised Phase IV clinical trial protocol presented by Sun Pharma. After detailed deliberation, the SEC issued its recommendation, stating:

“After detailed deliberation, the Committee recommended to grant the permission to conduct Phase IV clinical trial as per protocol presented by the firm.”

Esomeprazole is a proton pump inhibitor (PPI) widely used to reduce gastric acid secretion. Dual release formulations are designed to offer prolonged acid suppression, potentially improving therapeutic outcomes in acid-related gastrointestinal disorders such as gastroesophageal reflux disease (GERD) and peptic ulcer disease.

The Phase IV trial represents a post-marketing clinical investigation intended to generate additional safety and efficacy data under routine clinical use conditions. This aligns with regulatory requirements for monitoring the real-world performance of higher-dose or specialized formulations.

The SEC’s decision clears the way for Sun Pharma Laboratories Limited to move forward with its Phase IV clinical trial of Esomeprazole Dual Release Gastro-resistant Tablets 80 mg in accordance with the approved study protocol.

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Pharmacy Institutions Failing to Submit Data by Aug 31 to Lose 2025-26 Approval: PCI

New Delhi: The Pharmacy Council of India (PCI) has issued a final reminder to pharmacy institutions seeking approval under Section 12 for the 2025-26 academic session, directing them to submit complete additional information between August 26 and August 31, 2025.

The Council noted that despite repeated opportunities, some institutions have failed to provide the required details. As a result, such institutions were placed in the category of “Not to make admissions in the first year for 2025–26.”

According to the latest circular, several institutions had failed to submit the complete documents within the stipulated time, despite earlier notifications dated 3 July 2025 and 24 July 2025.

In this connection, the Pharmacy Council of India (PCI) informs that—

a) Some institutions have failed to submit the complete additional information regarding u/s 12 approval after repeated opportunities given.

b) Council has conveyed the decision to the institutions to not grant approval u/S 12 for the 2025-2026 academic session and the institutions for said course are placed under the category of “Not to make admission in 1st year” for the 2025-2026 academic session.

However, PCI has now given a last opportunity for compliance. Institutions must ensure that all required tabs on the PCI portal are completely filled within the specified window.

In view of the above, through the recent circular, it is stated,

“The last opportunity to submit the complete additional information and ensure that each and every tab should be filled for considering approval u/s 12 for the 2025-2026 academic session and the portal will be open from 26.8.2025 to 31.8.2025.”

The Council has cautioned that failure to meet this deadline will result in applications being summarily rejected and not considered for approval under Section 12 for 2025–26.

To view the official notice, click the link below:

https://medicaldialogues.in/pdf_upload/14-56circular2025-26-299193.pdf

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