News|Articles|December 1, 2025

Top 5 pediatric health headlines you missed in November 2025

Take a quick look at everything you may have missed this month, including the top FDA approvals and latest clinical updates.

November 2025 brought new insights and policy shifts with direct implications for pediatric prevention, infectious disease management, and early risk assessment.

In this monthly recap, Contemporary Pediatrics reviews the most significant developments shaping pediatric practice and public health. Click each title below for full coverage.

1. FDA, CDC investigating multistate infant botulism outbreak tied to formula

The FDA and CDC are urging parents and caregivers to immediately stop using all ByHeart infant formula products amid a multistate investigation into a growing outbreak of infant botulism linked to potential Clostridium botulinum contamination. As of November 26, 2025, 37 infants across 17 states have been hospitalized with suspected or confirmed cases, all of whom were exposed to various lots of ByHeart Whole Nutrition Infant Formula. Illness onset dates span August through November, and laboratory confirmation is ongoing.

The nationwide recall now includes all ByHeart powdered formulas following an initial limited recall on November 8. Infant botulism is a rare but life-threatening illness caused by a neurotoxin that can lead to muscle paralysis, respiratory failure, and death. Federal officials advise families to stop using the products, monitor exposed infants closely, and seek urgent medical care if symptoms such as poor feeding, weak muscle tone, difficulty swallowing, or decreased facial expression appear. The FDA also advises retaining formula containers for potential testing and instructs clinicians to seek immediate consultation when botulism is suspected.

2. CDC updates website, opens door for autism and vaccines link

The CDC has drawn national scrutiny after updating its Autism and Vaccines webpage on November 19, 2025, to state that the claim “vaccines do not cause autism” is not evidence-based, asserting that studies have not ruled out a causal link and that health agencies have historically “ignored” research suggesting an association. The agency also announced a new “comprehensive assessment” into biologic mechanisms and potential causal pathways. The American Academy of Pediatrics immediately condemned the changes, emphasizing that more than 40 high-quality studies involving over 5.6 million people across seven countries have found no connection between vaccines and autism, warning that the revised language promotes misinformation and undermines routine immunization.

Other CDC pages continue to state definitively that vaccines are safe and not linked to autism, creating inconsistent messaging. The update comes amid broader federal shifts under HHS Secretary Robert F. Kennedy Jr., including changes to pediatric COVID-19 vaccine recommendations and the removal of immunization advisory committee members—actions that experts say have fueled rising vaccine hesitancy. National vaccine leaders, including Paul Offit, MD, and Mary Koslap-Petraco, DNP, continue to affirm the strong scientific consensus supporting vaccination and warn that the CDC’s revised language risks reversing decades of progress against vaccine-preventable diseases.

3. AHA issues 2025 CPR and ECC updates for choking, opioid overdose, and pediatric care

The American Heart Association has issued its 2025 CPR and emergency cardiovascular care (ECC) guidelines, the first full update since 2020, introducing major changes in choking response, opioid overdose management, and pediatric resuscitation. The revision standardizes choking guidance across all ages, recommending 5 back blows followed by 5 abdominal thrusts for conscious children and adults, and 5 back blows followed by 5 chest thrusts for infants. A new opioid overdose algorithm provides clear public instructions on recognizing overdose symptoms and administering naloxone.

The AHA also returns to a single chain of survival for all cardiac arrest scenarios and expands community CPR training recommendations, emphasizing that children aged 12 years and older can learn effective CPR and defibrillation. Co-developed with the American Academy of Pediatrics, the pediatric and neonatal updates include delayed cord clamping for at least 60 seconds to improve newborn blood health. Updated training materials will be distributed globally to support implementation and improve survival from out-of-hospital cardiac arrest, which affects 350,000 people annually in the United States.

4. Early genetic testing may reshape care for inherited connective tissue disorders in children

Early genetic testing is emerging as a critical tool for managing inherited connective tissue disorders in children, allowing clinicians to identify at-risk individuals sooner and tailor monitoring and intervention. In this Q&A, genetic counselor Rajani Aatre, MS, MSc, LCGC, explains that children with a familial pathogenic variant have a 50% chance of inheriting the mutation, and early testing can spare half of them from lifelong surveillance while enabling timely management—including prophylactic medications and activity modifications—for those who test positive.

Pediatricians play a central role by obtaining thorough family histories, initiating referrals for genetic counseling, and correcting common misconceptions about inheritance patterns. Genetic counselors help families manage adjustment, coordinate additional testing, and address emotional concerns such as guilt or anxiety. Aatre also highlights how expanding technologies—from whole genome sequencing to emerging gene-targeted therapies and pre-implantation testing—are poised to reshape care, offering earlier detection and potential disease-modifying options for children with hereditary cardiovascular risk.

5. Linaclotide demonstrates positive long-term safety

Long-term data presented at the 2025 NASPGHAN Annual Meeting show that linaclotide (Linzess)—recently approved as the first FDA-authorized treatment for pediatric irritable bowel syndrome with constipation (IBS-C) in patients aged 7 to 17 years—continues to demonstrate a favorable safety profile with a low incidence of diarrhea. The FDA’s November 5 approval was supported by adult efficacy data and a pediatric randomized trial meeting modified Rome III criteria, where outcomes mirrored those seen in adults. In the ongoing 52-week phase 3 extension study, 98 children and adolescents received daily linaclotide (145 μg or 290 μg). Only 6.1% experienced diarrhea as a treatment-emergent adverse event, and no discontinuations were attributed to adverse effects. The findings reinforce linaclotide’s tolerability and support its role as a long-term management option for pediatric IBS-C.

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