Practical Information for Today's Pediatrician
Joined January 2023
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The FDA issued a Warning Letter today to Happiest Baby, maker of the SNOO Smart Sleeper bassinet, citing multiple violations with direct implications for clinical practice.
📄 Full article: hubs.ly/Q04ltPxs0
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⚠️ RECALL ALERT ⚠️
Nara Organics Whole Milk Organic Powdered Infant Formula has been recalled following a multistate outbreak of infant botulism affecting babies in California, Pennsylvania, and Washington. All 3 infants were hospitalized.
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🚨The FDA has approved teplizumab (Tzield) to delay the loss of endogenous insulin production in children and adolescents aged 8 to 17 years recently diagnosed with Stage 3 type 1 diabetes.
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Researchers at CHOP have identified a high-risk immune endotype in children with multiple organ dysfunction syndrome (MODS), with or without sepsis.
Read the full story: hubs.li/Q04lg4Z80
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📱 New Surgeon General advisory: Excessive screen use may affect children's development, sleep, mental health, physical health, and academic performance.
Read more: hubs.li/Q04lgtb_0
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New research in JAMA Network Open found that mental health-related diagnoses are being addressed more frequently during primary care visits, with anxiety showing nearly a 300% increase over the past decade.
🔗 Read the full story: hubs.li/Q04lfZSz0
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🚨 FDA update: TOFIDENCE (tocilizumab-bavi; @organonllc) has received expanded indications for patients aged 2 years and older with cytokine release syndrome and for hospitalized patients with COVID-19 who require corticosteroids and respiratory support.
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☀️ A major sunscreen milestone: The FDA has added bemotrizinol to the OTC sunscreen monograph, marking the first new active sunscreen ingredient approved in the US in more than 20 years.
Read more: hubs.li/Q04kX0QV0
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🚨 The FDA has accepted @TakedaPharma’s application for IV vedolizumab in children as young as 2 years with ulcerative colitis or Crohn’s disease.
If approved, it would become the first gut-selective biologic available for pediatric patients with IBD.
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The FDA has approved lebrikizumab (EBGLYSS; @EliLillyandCo) for Q8W maintenance dosing in moderate-to-severe atopic dermatitis, as few as 6 injections/year, no required topicals.
Approval based on exposure-response modeling ADjoin extension data.
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A research letter recently published in JAMA Pediatrics provides timely quasi-experimental evidence that the influenza vaccine reduces clinically meaningful infections in children aged 2 to 5 years across multiple seasons.
More: hubs.li/Q04kLPZm0
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The FDA has granted orphan drug designation and rare pediatric disease designation to GEn-1123, an investigational oral small-molecule therapy being developed by GEn1E Lifesciences for Duchenne muscular dystrophy (DMD).
Read more: hubs.li/Q04kLGyx0
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New in JAMA Pediatrics: After Australia updated guidelines to recommend egg introduction by 6 months, egg allergy in 1-year-olds dropped ~18%.
The biggest benefit? Infants with early eczema saw allergy rates fall from 34.6% → 21.9%.
Read more: hubs.li/Q04kzBxl0
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🚨The @US_FDA has expanded approval of marstacimab (HYMPAVZI; @pfizer) to patients aged 6 years and older with hemophilia A or B, with or without inhibitors, offering a once-weekly subcutaneous prophylactic option.
Read the full coverage: hubs.li/Q04ksnJX0
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Jamie Wood, MD, discusses the FDA approval of Afrezza for pediatric patients and why expanding treatment options matters for children and families living with diabetes.
Read more: hubs.li/Q04kcmxx0
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Our Top 5 Headlines of May included a landmark FDA approval for the first rapid-acting inhaled insulin, new evidence reaffirming HPV vaccine safety, updated AAP drowning prevention guidance, and a global effort to rename PCOS to PMOS.
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The FDA has expanded approval of linaclotide (LINZESS) to children aged 2-5 years with functional constipation, making it the only FDA-approved prescription therapy for pediatric FC in this age group.
Read more: hubs.li/Q04jYTSz0
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The FDA has approved XOCOVA (ensitrelvir; @ShionogiUS ) for post-exposure prophylaxis of COVID-19 in adults and adolescents aged 12 years and older.
Read more: contemporarypediatrics.com/v…
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Missed an approval last month? Don't worry, we've got you covered with our monthly FDA recap! Click the link to catch up on any pediatric FDA approvals you may have missed in May.
contemporarypediatrics.com/v…
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In this HS Awareness Week interview, Colleen Cotton, MD, of @ChildrensNatl , discusses why pediatricians should recognize HS early and how timely intervention may help prevent scarring and disease progression.
Watch episode 1 of this 5-part series here: contemporarypediatrics.com/v…
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