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Content Writing Tips: Improve Your Skills & Productivity

by Dr. Michael Lee – Health Editor
written by Dr. Michael Lee – Health Editor

The Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) has announced it is assessing new data on the potential risk of neurodevelopmental disorders (NDDs) in children born to men treated with valproate during spermatogenesis. The announcement comes after controversial new precautionary measures for the treatment of male patients with valproate medicines were imposed in January 2024.

The cautionary approach to valproate — a medicine used to treat epilepsybipolar disorders, and in some countries migraine — came about as a result of a post-authorization safety study (PASS) funded by a consortium of marketing authorization holders for valproate and related substances. After examining the results, PRAC recommended that valproate treatment in male patients be started and supervised by a specialist in the management of epilepsy, bipolar disorderor migraine. It also said that valproate treatment of male patients should be reviewed regularly to consider whether it remains the most suitable treatment, particularly if the patient is planning to conceive a child.

Original Study Suggests Risk

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PASS was a population-based retrospective study that used data from multiple Scandinavian registry databases in Denmark, Norway, and Sweden, together with other available information, to evaluate the association between paternal exposure to valproate and the risk of NDDs in offspring, including autism spectrum disorders, intellectual disability, communication disordersattention deficit/hyperactivity, and movement disorders, as well as congenital abnormalities.

The results suggested a potential increased risk to children born to men treated with valproate during the 3 months before conception. This led PRAC , and later the UK’s Medicines and Healthcare products Regulatory Agencyto recommend precautionary measures for the treatment of male patients with valproate medicines. These measures were in addition to restrictions already in place since 2018 to avoid valproate exposure in pregnancy due to evidence of an increased risk of malformations and developmental problems.

Second Study Casts Doubt

At that time, the committee acknowledged that the PASS data had limitations but concluded that the potential risk warranted informing patients and healthcare professionals.

However, a study published in JAMA in June 2024 using a subset of the same data cast doubt on the PASS findings.

That study aimed to replicate the PASS results using the nationwide Danish data sources that had been used in PASS. In this later study, 1336 children among the total cohort of 1,235,353 children had been born to fathers who filled prescriptions for valproate during spermatogenesis. No association was found between paternal valproate use and risk of major congenital malformations or NDDs, the researchers said.

The researchers highlighted that the PASS results stemmed from an observational study report prepared by contract research organization IQVIA. “We were unable to replicate the IQVIA study results,” they said.

Latest Study Shows No Risk

The same research team subsequently published a research letter in JAMA in May 2025, in which they said that they had access to only limited information about the IQVIA study at the time of their 2024 report. Following publication of the detailed IQVIA report, the team conducted analyses to explore the impact of methodological choices and definitions used in that study.

“Paternal valproate exposure was not associated with an increased risk of NDDs,” they concluded. This was the case for the composite endpoint of all NDDs and “remained robust” across analyses of specific NDDs, expanded definitions of NDDs, valproate dose, time trends, polytherapy, and analyses restricted to fathers with epilepsy.

PRAC said that, in the light of this latest study’s inability to replicate the signal for NDDs in children with paternal valproate exposure and a more recent systematic review from Australia that also showed “no clear evidence for an adverse impact of paternal antiseizure medication use on offspring outcomes,” the committee has initiated a signal procedure to understand the difference in the findings across the studies.

It has also requested further information and analysis from valproate marketing authorization holders. The EMA will communicate further when more information becomes available, it said.

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Entertainment

Richard Gere chastised by Paul Simon’s daughter over demolition of her childhood home

by Julia Evans – Entertainment Editor
written by Julia Evans – Entertainment Editor
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News

Explosion in Rome: Claudio Ercoli, the inspector who was injured after the outbreak of the distributor who died

by David Harrison – Chief Editor
written by David Harrison – Chief Editor

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Rome Gas Station Explosion Claims Life

Inspector succumbs to severe burns days after incident.

A devastating explosion at a Rome petrol station has claimed the life of **Claudio Ercoli**, a 67-year-old inspector. He died Wednesday at Sant’Eugenio hospital, succumbing to injuries sustained in the blast that occurred last Friday.

Tragic Outcome After Extensive Treatment

**Ercoli** suffered third-degree burns across 55% of his body. ASL Roma 2 reported that he underwent a complex skin graft procedure on Tuesday. Despite every effort by the medical team, his condition gradually worsened due to the severity of the burns.

A first responder, a member of the Carabinieri, rescued **Ercoli** from his burning vehicle. He was transported to the emergency room, where he was identified as the most critically injured victim.

Mayor Expresses Condolences

Roberto Gualtieri, the Mayor of Rome, shared his sorrow: “With deep pain I learned of **Claudio Ercoli’s** tragic disappearance… In this moment of sadness, the whole city joins the condolence for this loss. On behalf of Rome I wish to express our sincere closeness to his family, to his friends and those who loved him.”

Remembering a Helpful Friend

**Marco**, a childhood friend of **Ercoli**, fondly recalled their shared history in the Villa Gordiani district: “With **Claudio** we are grown together in the Villa Gordiani district… A good person, altruistic. If there was someone to help, he was always the first to run. I hoped until the last that would make it.”

**Marco** also spoke of **Ercoli’s** love for animals and his 40-year marriage to **Mariagrazia**. He described visiting **Ercoli** at the petrol station and his disbelief upon hearing the news.

Other Victims

Another patient remains in critical but stable condition with burns covering 25% of their body, according to ASL Rome 2. Police inspector **Marco Neri** and police officer **Francesco D’Onofrio**, who sustained serious burns, were scheduled to undergo reconstructive surgery at the Policlinic Umberto I.

Company Clarification

Initially misidentified as an Eni employee, the company clarified that **Ercoli** was not directly employed by them. Eni stated that the petrol station is operated by Ecogasauto srl, which uses the Eni brand, and that Ecogasauto manages the LPG on site.

Ongoing Fire Emergency

The incident occurs amid an ongoing fire emergency in the capital. Recent reports indicate that 90% of wildfires are started by humans (NIFC 2023).

Another fire broke out in Fiumicino, near Rome, adding to the challenges faced by emergency services.

For more updates, sign up for the Corriere Roma newsletter.

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Health

Surgery Resolves Limb Movements in Pediatric Sleep Apnea

by Dr. Michael Lee – Health Editor
written by Dr. Michael Lee – Health Editor

TOPLINE:

Table of Contents

Periodic limb movements in sleep (PLMS) were found to be common in children with obstructive sleep apnea (OSA), with age and severity of OSA influencing its prevalence. In most cases, adenotonsillectomy effectively resolved PLMS.

METHODOLOGY:

  • Researchers conducted a retrospective study to evaluate the prevalence of PLMS in children with OSA and assess the effect of adenotonsillectomy on these movements.
  • They enrolled 1159 children (median age, 5 years; 58.3% boys) with OSA who underwent adenotonsillectomy between January 2022 and July 2023 at a tertiary care children’s hospital.
  • The severity of OSA was categorized using the obstructive apnea-hypopnea index as mild (1-4 events per hour), moderate (5-9 events per hour), or severe (10 or more events per hour).
  • Elevated periodic limb movement index (PLMI) was measured as PLMS per hour before and after adenotonsillectomy, with an elevated PLMI defined as more than 5 events per hour.

TAKEAWAY:

  • Children older than 5 years had a higher prevalence of an elevated PLMI than those younger than 5 years (odds ratio, 0.3; P < .001).
  • The odds of elevated PLMI were 2.3 times higher in children with moderate OSA (P = .007) and 1.9 times higher in those with severe OSA (P = .01) than in those with mild OSA.
  • The PLMI significantly reduced after adenotonsillectomy (11.9 vs 2.9; P ≤ .001). Among 54 children with an elevated PLMI who underwent follow-up polysomnography, 85% showed resolution after adenotonsillectomy.
  • Children with residual OSA had a higher PLMI than those without residual OSA (P = .04).

IN PRACTICE:

“The potential clinical implications of our findings are the consideration of AT [adenotonsillectomy] for the initial management of children with OSA and elevated PLMI and counseling caregivers regarding the treatment of elevated PLMI,” the authors of the study wrote.

SOURCE:

This study was led by Amor Niksic, University of Texas Southwestern Medical Center, Dallas. It was published online on June 07, 2025, in The Laryngoscope.

LIMITATIONS:

The retrospective study design limited data collection on sleep characteristics, patient symptoms, the impact of adenotonsillectomy on symptoms, and serum ferritin levels. Additionally, the small number of children who underwent polysomnography before and after adenotonsillectomy may have affected the detection of differences in subgroup analyses.

DISCLOSURES:

The authors reported receiving no specific funding for this work and reported having no conflicts of interest.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.

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Health

Dietary Advice for Moms Reduces Infant Allergies: New Study

by Dr. Michael Lee – Health Editor
written by Dr. Michael Lee – Health Editor

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Early Infant Feeding Advice Significantly Reduces Food Allergies, Study Shows

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Providing parents with updated infant feeding advice, particularly regarding the early introduction of allergenic foods, dramatically reduces the progress of food allergies in the first year of life. A recent study adds to a decade of research showing the benefits of introducing foods like eggs and peanuts when first starting solids.

Australian Study Confirms Benefits of Early Allergen Introduction

An Australian study published in the Journal of Allergy and Clinical Immunology: In Practice, examined the impact of updated infant feeding guidelines on the prevalence of immunoglobulin E (IgE) antibody-mediated allergies. The study found that early introduction of allergenic foods significantly lowered the rates of egg, peanut, and cow’s milk allergies. The research also emphasized the importance of ensuring parents receive and understand the latest dietary guidance on food allergy prevention [[source]].

did You Know? The American Academy of Pediatrics also supports the early introduction of perhaps allergenic foods into infant diets [[source]].

Study Design and Key Findings

The study, led by Debra Palmer, PhD, compared two infant cohorts born before and after the implementation of Australia’s infant feeding and allergy prevention guidelines in 2016. All babies had a high familial risk for allergies, with a first-degree relative having a history of allergic disease.

In the first cohort (506 infants born 2006-2014),families received no specific feeding advice. In the second cohort (566 infants born 2016-2022), families received updated infant feeding and allergy prevention guidelines when the infants were 6 months old.

By 12 months of age, the vast majority of infants in the second cohort had been introduced to peanuts (94.2%), eggs (99.3%), and cow’s milk (98.6%).

The results showed a notable reduction in food allergies in the second cohort. The combined prevalence of IgE-mediated peanut, egg, and cow’s milk allergies was just 4.1% in cohort 2, compared to 12.6% in cohort 1. This represents an adjusted odds ratio (aOR) of 0.28 (95% CI, 0.16-0.48; P < .001).

Individual allergy prevalence also decreased significantly:

  • Peanut: 1.1% in cohort 2 vs 5.8% in cohort 1 (aOR, 0.24; 95% CI,0.08-0.76; P = .015)
  • Egg: 2.8% in cohort 2 vs 11.7% in cohort 1 (aOR, 0
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Health

Fathers’ Mental Health May Predict Poor Child Development

by Dr. Michael Lee – Health Editor
written by Dr. Michael Lee – Health Editor

Fathers’ Mental Health Linked to Child Development Challenges

A new study reveals a concerning connection: when fathers grapple with mental health issues around their children’s births, their offspring may face developmental hurdles. The findings highlight a critical need to support fathers through the significant transition into parenthood, benefiting both parents and children.

Study Findings

A meta-analysis published in JAMA Pediatrics examined the link between paternal mental health and child development. Researchers analyzed data from over 9,500 studies across 21 countries. The study focused on fathers’ experiences with depression, anxiety, and stress, and the impact on their children’s development from infancy through adolescence.

The study’s lead author, Delyse Hutchinson, PhD, from Deakin University in Australia, emphasized the importance of recognizing parenthood as a period of both joy and stress for men. The research team assessed factors like global, social-emotional, and cognitive development in the children.

The data indicated that during the perinatal period, 8% of men experienced clinical depression, 11% had anxiety, and between 6% and 9% showed elevated stress levels. The study showed a correlation between fathers’ mental distress and poorer developmental outcomes in their children. These included social-emotional, cognitive, language, and physical development.

According to the study, children whose fathers experience distress during the perinatal period are at increased risk. These children may face mental health issues and behavioral or social difficulties. These challenges often extend into adulthood, potentially creating a difficult cycle to break.

Expert Insights

Karen Wynter, MD, from Monash University in Australia, noted that these challenges can often last into adulthood, making them difficult to overcome. The study’s findings align with existing research, underscoring the importance of paternal mental health.

Craig Garfield, MD, of Northwestern University Feinberg School of Medicine, pointed out the timely nature of this research. Fathers are increasingly involved in childcare, making their well-being critical to family health. The study underscores the need for mental health screenings for fathers.

Supporting Fathers

Hutchinson stated that the results emphasize the necessity of bolstering emotional support for fathers. This could involve mental health screenings prior to and following a child’s birth. Recognizing fathers as active participants in childcare is essential.

Wynter said, Fathers want to be involved in parenting their infants. Society no longer regards them as only ‘breadwinners’ or ‘supporters.’ They are nurturing, caring parents who, like mothers, may experience emotional difficulties in the transition to parenthood, and there should be no shame or judgment if they seek help.

A recent study by the CDC found that the percentage of fathers experiencing symptoms of postpartum depression is on the rise, with 10.4% of fathers reporting these symptoms in 2024 (CDC).

Conclusion

This research highlights the crucial role of paternal mental health in child development. Supporting fathers during the transition to parenthood can improve their well-being and contribute to better outcomes for their children, making it a priority for healthcare and social support systems.

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