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The FDA announces significant updates on acetaminophen risks in pregnancy and approves leucovorin calcium for treating CFD in children.

FDA Announces Label Changes for Acetaminophen in Pregnancy, Approves Leucovorin Calcium for CFD

. He joined the brand in March of 2023 as an editor before being promoted to senior editor in January 2024. Fitch graduated from Youngstown State University in Youngstown, Ohio in 2020 with a degree in telecommunications and journalism. He started his career as a news and sports videographer before becoming an on-air sports anchor at the NBC-affiliated news station in Youngstown. Fitch briefly worked as a national content writer for a Chicago-based national television station before joining the 

team. He can be reached at: jfitch@mjhlifesciences.com.

 and joined the MJH Life Sciences team in December 2019. She graduated from Youngstown State University in 2019 with a bachelor's degree in journalism and a minor in political science. Prior to graduating, Morgan worked as the editor-in-chief of her college newspaper. She went on to work as an assignment editor at a broadcast news station in Youngstown, Ohio before joining 

 You can reach her at mpetronelli@mjhlifesciences.com.

Zilganersen met the primary endpoint of gait stabilization in a pivotal study of Alexander disease, showing statistically significant benefit on gait speed and favorable safety.

Zilganersen demonstrates stabilization of gait speed for Alexander disease

The planned phase 2 study of SAT-3247 will evaluate safety, tolerability, and functional outcomes in children with Duchenne muscular dystrophy. 

Satellos submits SAT-3247 IND for phase 2 study in children with DMD

The federal agency granted accelerated approval to elamipretide HCl to treat patients with Barth syndrome.

FDA approves elamipretide HCI as first treatment for Barth syndrome

Contemporary Pediatrics connects pediatricians with peer-reviewed articles, guideline updates, and practice strategies for real-world clinical application.

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Kim Lee, PharmD, BCPPS, is the residency program director at Lucile Packard Children's Hospital Stanford.

Explore essential resources and toolkits for managing the ongoing stimulant medication shortage affecting ADHD treatment and patient care.

A brief review of primary care resources and toolkits for the stimulant shortage

**Editor's Note** Please note that starting January 1, 2025, we will be switching to an online-exclusive publication process. This will allow us to publish case submissions quicker without having to deal with the variables that come along with print publication. All cases will still be eligible for print publication consideration, but publication in our print magazine is not guaranteed and will be up to the editor's discretion. 

Do you have a puzzling pediatric case that you’d like to share with the readers of 

We are looking for intriguing diagnoses that have stumped the experts—a diagnostic “Puzzler”—to help our physicians enhance their day-to-day practices. If you have such a story to tell, tell us.

Here’s what to do: Before you begin, we suggest that first you review the Puzzler 

https://www.contemporarypediatrics.com/case-studies

. Please note the specific style required for writing Puzzler manuscripts.

Next, prepare a draft of your case, including a summary of the presenting symptoms, a case overview, a 

table of the differential diagnosis (MANDATORY)

, and the special aspects of your case that qualify it as a Puzzler, and send it to us. Please note that the differential diagnosis table should also be discussed in the body text. We’ll review your draft and let you know what you need to add or revise before we send the manuscript to peer review for evaluation.

Puzzlers vary in length, and we suggest a minimum of 1,200 words up to a maximum of 2,000 words, but that is because of the complexity of some cases and whether some patients returned for many assessments before their diagnoses were determined. Also, some authors describe the pathophysiology of the differentials in great detail. Please also note no more than 3 authors are allowed per article.

What's most important is to show us the process that you used to analyze the case, including:

Why you decided to order certain tests and why you did not order others.

Peer consultations or why you elected to contact other specialists.

Lab values including vital signs or blood tests.

Labs and values if your patient was attended to in the emergency department or other hospital departments such as radiology or neurology.

Discussion related to the possible diagnoses.

Final diagnosis, treatment, prognosis, and follow-up.

Remember to indicate numbered citations within the body of the text and include a complete list of corresponding literature/references at the end of the manuscript. (Do not use any citation management programs or unlink them.) 

Limit references to 25. No references (unless it is a seminal study) can be older than 10 years.

We prefer primary research as references, but some cases are so obscure that authors will need to pull from a variety of sources. However, 

. Be advised that peer reviewers are adamant that the disease/disorder you describe was actually diagnosed and not determined by index of suspicion on the basis of ruling out various differentials. We use AMA11 as our publication style, which uses superscript citation numbers and a corresponding numbered reference list. Please create your citations and references in this style.  Check this recent article posted online at 

https://www.contemporarypediatrics.com/view/the-rx-of-adhd

 for examples of reference style. IMPORTANT NOTE WITH AMA 11TH EDITION: PLEASE PUT DOI OR WEBSITES/URLS AT THE END OF THE REFERENCE LINE.

When you send your draft manuscript, also 

. These image files must be high-resolution jpg or tiff files (minimum of 300 dpi) and as large in size as possible. We suggest a minimum of 7 horizontal inches. The images must be original photos with clear permissions to use, not images from copyrighted sources. Send as separate attachments with your e-mail submission; do not embed images into your manuscript document.

After we receive your manuscript, our editors and peer reviewers will review your draft and let you know if we accept your submission for publication. 

Puzzler is one of the departments for which we receive the most submissions, so it may be several months after submission before you receive feedback from us.

If we do accept your submission for publication, we will contact you with further instructions.

Send your submissions in Microsoft Word format to 

, via e-mail to mpetronelli@mjhlifesciences.com

Guidelines for PUZZLER, Contemporary Pediatrics

 poll. Take a look at the following case below. After reading through the description, choose a multiple-choice answer and try to guess the correct patient diagnosis.

Then visit our website on August 20 at 12:00 PM EST or later for the full case presentation, differential diagnosis, and correct patient diagnosis.

This case was provided by Andrew Faniku, MD, pediatric hospitalist at Scott & White Healthcare.

A 21-year-old primigravida female presented to the hospital in preterm labor, with an otherwise uneventful pregnancy except for a febrile illness after exposure to family members with measles a week prior.

She reported having fever, cough, conjunctivitis, and a rash that started on her face and spread to her trunk, consistent with measles. Her fever and symptoms had mostly resolved, except for her lingering rash that began six days earlier. In the delivery room, she still had fresh excoriation marks on her arms. She had not received any MMR vaccines.

Six hours after admission, the patient delivered a female infant via spontaneous vaginal delivery at 35 weeks’ gestation. The baby weighed 2410 grams, which was approximately the 50

 percentile for her gestational age. The baby had mild respiratory distress after delivery and briefly required supplemental oxygen via blow by during transitioning. Apgar’s of 8 at 1 minute and 9 at 5 minutes was given at delivery. The baby subsequently improved and was allowed to room in with mother without the need for NICU admission. Nursing staff noticed a rash on the baby’s back. 

Below, take your best guess at diagnosing this patient

 website on Wednesday, August 20 at 12:00 PM EST or later for the full case presentation, differential diagnosis, and correct patient diagnosis.

News

Case Studies

Can you diagnose this rash in a newborn?

 poll. Take a look at the following case below. After reading through the description, choose a multiple choice answer and try to guess the correct patient diagnosis. 

 on Wednesday, January 29 at 12:00 PM ET for the full case presentation, differential diagnoses, and the correct patient diagnosis. 

This case was provided by Nicholas W. Kieran, MS and Annuradha Goel, MD.

A 14-year-old girl presented to her primary care office with 2 weeks of vomiting that began when she tried to eat breakfast. She said she was feeling well up until that point, but then developed sudden onset vomiting and constant, 7/10, non-radiating chest pain centrally located at about the level of the second rib that remained unchanged since onset and slightly worsened when trying to eat. 

She was able to take in liquids but vomited all food, despite having an appetite. She denied feeling the food get stuck in her throat and endorsed continued vomiting of meals within 2 minutes of eating. She denied blood in the vomit and denied any abdominal pain. 

Urination was unchanged, and stools, although infrequent because of a lack of eating, continued to have their normal consistency and color. The patient did endorse some mild shortness of breath. This started around the same time as the other symptoms, but did not find it very bothersome. Her last sexual encounter was 3 months prior to this visit, just prior to Nexplanon (etonogestrel implant) insertion. Her last menstrual period was 2months prior to the visit.

On review of systems, she did not endorse palpitations, syncope, lightheadedness. She had increased her vape use recently but did not disclose when she started or how much she vaped. She had no recent travel and had not identified any extremity swelling. She was unsure if she had lost weight but had not been trying to lose any.

website on Wednesday, January 29, 2025, at 12:00 PM ET or later for an article featuring the full case presentation, differential diagnosis, and correct patient diagnosis.

The patient had increased her vape use recently, but did not disclose when she started, or how much she vaped. 

14-year-old girl presents with chest pain, 2-week history of vomiting

At 32 6/7 weeks, a 1970-g child was born via meconium-stained vaginal delivery to a 37-year-old mother (gravida 2, para 1) who recently immigrated from India. The mother presented with preterm premature rupture of membranes for 11 hours prior to eventual vaginal delivery. 

Maternal history was otherwise notable for rubella nonimmunity, advanced maternal age, and a prior history of intrauterine fetal death 4 years prior. Prior to delivery, the mother received one dose of ampicillin given her unknown group B 

 status and a single dose of betamethasone to accelerate fetal lung maturity.

After delivery, the newborn was vigorous, with delayed cord clamping of 1 minute. The Apgar scores were 8 and 8 at 1 and 5 minutes of life, respectively. There was mildly increased respiratory effort in the delivery room, for which continuous positive airway pressure (CPAP) respiratory support was begun. The child was brought to the neonatal intensive care unit with CPAP of 5 and 30% fraction of inspired oxygen. 

E. coli with extended spectrum beta-lactamase

 website on Wednesday, September 10, at 12:00 PM EST or later for the full case presentation, differential diagnosis, and correct patient diagnosis. 

A recently immigrated mother from India presents in preterm labor at 32 6/7 weeks and delivers a vigorous baby whose initial blood culture result is positive at 18 hours of life with gram-negative rods. 

Can you diagnose this infant with neonatal respiratory distress?

ARS Pharmaceuticals announced real-world evidence supporting the effectiveness of neffy (epinephrine nasal spray) in treating anaphylaxis symptoms in patients undergoing oral food challenge or allergen immunotherapy, according to correspondence accepted for publication in 

Neffy was first approved on August 9, 2024, for children with a weight of at least 66 lb and then further expanded to include patients 4 years or older on 

In the analysis, 545 patients who experienced anaphylaxis symptoms during oral food challenge or immunotherapy were treated with neffy by a health care provider. In all, 89.2% of patients treated with the epinephrine spray achieved symptom resolution with a single dose. This success rate mirrors findings from meta-analyses of epinephrine intramuscular injection or auto-injector, which report single-dose effectiveness in 88.9% of patients treated for food-induced anaphylaxis, according to ARS. 

RX Review: The role of needle-free epinephrine in pediatric allergy for 2025

“These data reinforce existing findings and are the first large-scale report of real-world treatment outcomes with neffy during anaphylaxis events,” said Thomas B. Casale, MD, professor of medicine and pediatrics and chief of clinical and translational research at University of South Florida Health Morsani College of Medicine’s Division of Allergy and Immunology, in a statement. “The finding that about 9 out of every 10 patients were successfully treated with a single dose of neffy in more than 500 patients is essentially identical to the historic response rates observed with epinephrine injection.”

The new evidence complements previously published clinical studies of neffy, including a phase 3 prospective trial of 15 patients undergoing oral food challenge. In that study, all patients responded to neffy without the need for a second dose to manage their initial reaction.

Neffy is the first and only needle-free epinephrine product approved for use in the United States for the treatment of severe allergic reactions, including anaphylaxis. The nasal spray formulation was designed to overcome barriers to timely treatment, such as needle phobia and incorrect use of auto-injectors. ARS Pharmaceuticals emphasized that the pharmacokinetic and pharmacodynamic profiles of neffy align with those of established epinephrine injection products, supporting its clinical interchangeability.

“The real-world outcomes data support the clinical interchangeability of neffy and epinephrine injection, building on the clinical studies conducted for FDA approval,” Casale added. “Neffy achieved blood levels and pharmacodynamic responses within the range of approved injection products.”

Anaphylaxis is a life-threatening systemic allergic reaction that requires immediate treatment with epinephrine. Historically, treatment has relied on intramuscular injection, typically delivered via auto-injector. However, challenges such as access, cost, and patient hesitation with needle-based products can delay administration.

ARS Pharmaceuticals announces real-world evidence of neffy (epinephrine nasal spray) effectiveness in patients experiencing anaphylaxis symptoms. Press release. ARS Pharmaceuticals Inc; September 2025.

Fitch J. Neffy 1 mg now available for anaphylaxis in children aged 4 years and up. 

. May 7, 2025. Accessed September 9, 2025. https://www.contemporarypediatrics.com/view/neffy-1-mg-now-available-for-anaphylaxis-is-pediatric-patients

Fitch J. FDA approves neffy 1 mg for anaphylaxis in children aged 4 years and older. 

. March 6, 2025. Accessed September 9, 2025. https://www.contemporarypediatrics.com/view/fda-approves-neffy-for-anaphylaxis-in-children-aged-4-years-and-older

Schroer B, Kraft C, Traister R. RX Review: the role of needle-free epinephrine in pediatric allergy for 2025. 

. March 12, 2025. Accessed September 9, 2025. https://www.contemporarypediatrics.com/view/rx-review-the-role-of-needle-free-epinephrine-in-pediatric-allergy-for-2025

Ebisawa M, Takahashi K, Takahashi KK, et al. Epinephrine nasal spray improves allergic symptoms in patients undergoing oral food challenge, phase 3 trial. 

. Published online July 8, 2025. doi:10.1016/j.jaip.2025.06.038

Real-world evidence supports neffy as comparable to epinephrine injection in anaphylaxis care.

Neffy demonstrates positive, real-world data for anaphylaxis

On September 15, 2025, the FDA expanded the beremagene geperpavec-svdt (B-VEC; Vyjuvek; Krystal Biotech) indication to include patients from birth with dystrophic epidermolysis bullosa (DEB), expanding on the previous indication of 6 months or older.

Originally approved by the FDA in May 2023, B-VEC can now provide full flexibility with respect to application and management of wound dressings, according to a press release from Krystal Biotech. In addition to allowing patients with DEB and caregivers to apply B-VEC at home and on their own, the label update allows wound dressings to be removed as part of the next dressing change rather than waiting 24 hours. 

The updated label is based on real-world data collected since B-VEC was launched in the United States, following its approval in May 2023. 

Kim Lee, PharmD, BCPPS

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