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. 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.

Articles

H. Westley Phillips, MD, joined us to provide clinical pearls regarding the early identification of drug-resistant epilepsy patients in the primary care setting. 

Identifying drug-resistant epilepsy patients in primary care

With the decision, Kebilidi becomes the first FDA-approved gene therapy for AADC deficiency, and is indicated for adult and pediatric patients. 

FDA approves Kebilidi as first gene therapy to treat aromatic L-amino acid decarboxylase deficiency

A discussion of tips and recommendations general providers can use when evaluating ADHD in pediatric patients. 

ADHD treatment: Clinical pearls for primary care providers

A target action date for potential approval of prademagene zamikeracel (pz-cel) has been set for April 29, 2025. 

FDA accepts BLA resubmission for pz-cel to treat recessive dystrophic epidermolysis bullosa

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Child abuse and neglect: it’s about prevention

Brittany Bruggeman, MD, highlights the importance of newer, easier-to-use glucagon formulations in treating severe hypoglycemia in patients with type 1 diabetes.

New glucagon formulations simplify emergency treatment for type 1 diabetes patients

Brittany Bruggeman, MD, a pediatric endocrinologist at the University of Florida and type 1 diabetes (T1D) physician scientist, highlighted crucial advancements in diabetes management, particularly regarding the use of glucagon for severe hypoglycemic events. 

Bruggeman emphasized the critical importance of having glucagon readily accessible for patients with T1D. “Glucagon is what I like to think of as the EpiPen of diabetes, and so it's very important that everybody with T1D, or even type 2 on insulin, has glucagon immediately available to them,” she said during an interview at the 

2024 American Academy of Pediatrics National Conference & Exhibition.

Recent developments in glucagon formulations have made it much easier to administer, especially in emergency situations. Bruggeman noted that older versions required users to mix a powder and liquid before injection, a process that could be confusing and time-consuming. “What we used to have to do is mix a powder and a liquid together before injecting the person with glucagon, which made it really tough for people in the lay public to know how to use this, and even, like school nurses and things, had to have special trainings,” she explained.

However, new formulations of glucagon have simplified the process, making it more accessible to non-medical personnel. “Now there's a formulation that is a nasal spray, and so literally, you just spray the powder into the person's nose,” Bruggeman said, highlighting how this change has improved usability. Additionally, there are now shelf-stable liquid versions of glucagon that function similarly to an EpiPen, allowing for a quick injection without needing to mix anything. 

Bruggeman stressed the importance of awareness among healthcare professionals and the public regarding these advancements. “It's really important that the lay public, pediatricians, [and] everyone knows about glucagon, and that if someone with T1D is on insulin, they need to have access to this in order to treat them if they had a severe hypoglycemic event,” she said.

Brittany Bruggeman, MD, highlights the importance of newer, easier-to-use glucagon formulations in treating severe hypoglycemia in patients with type 1 diabetes. 

News

New glucagon formulations simplify emergency treatment for T1D patients

Brittany Bruggeman, MD, emphasizes that many patients with type 1 diabetes are unaware of the availability of advanced technologies like CGMs and automated insulin delivery systems.

Communicating availability of continuous glucose monitors for type 1 diabetes patients

Brittany Bruggeman, MD, pediatric endocrinologist at the University of Florida and type 1 diabetes physician scientist, joined 

 to discuss the latest advances in technology for type 1 diabetes care. According to Bruggeman, “there are so many new aspects of technology that we now use routinely in type 1 diabetes,” highlighting the significant role of continuous glucose monitors (CGMs) and automated insulin delivery systems.

Bruggeman emphasized the convenience and effectiveness of CGMs, which allow patients to monitor blood glucose levels without frequent finger sticks. “People can rely on continuous glucose monitors for care and not have to do a finger stick, except for in very special circumstances," Bruggeman noted, adding that this gives both endocrinologists and patients peace of mind with round-the-clock monitoring. 

Another important advancement discussed was automated insulin delivery systems, where insulin pumps and CGMs work together to automatically adjust insulin levels based on real-time blood glucose data. These systems, Bruggeman explained, are crucial for patients on insulin, yet many are unaware of their availability. She stressed the importance of ensuring all patients with diabetes have access to these technologies, stating, “Something important that every patient with diabetes on insulin needs to know is that these systems are available to them." 

Bruggeman also pointed out the troubling health care disparities in the adoption of these technologies. Patients from lower socioeconomic backgrounds and minority groups are significantly less likely to use CGMs and automated insulin delivery systems.

“Unfortunately, half the rate of use of these technologies” exists among underserved populations, compared to non-Hispanic, White, more affluent patients. However, Bruggeman emphasized that “even with lower health literacy or lower socioeconomic status, people really can understand these new technologies.” She concluded that the design of these devices has become more intuitive, making them accessible to a broader population. As Bruggeman put it, “If you can use a phone, you generally can use most of these new technologies.” 

Brittany Bruggeman, MD, emphasizes that many patients with type 1 diabetes are unaware of the availability of advanced technologies like CGMs and automated insulin delivery systems. 

Brittany Bruggeman, MD, highlighted the ability to predict type 1 diabetes months to years in advance through islet autoantibodies.

Testing for islet autoantibodies to monitor type 1 diabetes development

At the 2024 American Academy of Pediatrics National Conference & Exhibition, Brittany Bruggeman, MD, a pediatric endocrinologist and type 1 diabetes physician scientist, University of Florida, provided key updates on the evolving care for type 1 diabetes. Her talk, titled "What’s New in Type 1 Diabetes Care," highlighted significant advancements in both technology and treatments that general pediatricians should be aware of. 

"There’s a lot that is new in type 1 diabetes care," Bruggeman emphasized. Given the rapid pace of these developments, she noted that general pediatricians, who "have to know a little bit about everything," would benefit from updates on the latest advances in managing the condition. 

One of the major points Bruggeman discussed was the importance of early detection in pre-type 1 diabetes. "We can actually tell that someone is going to develop type 1 diabetes months to years before they actually get type 1 diabetes, and we do that through something called islet autoantibodies," she said. These markers allow for early identification of individuals at risk, particularly those with relatives who have type 1 diabetes. 

"There is a new treatment called teplizumab that is an immune therapy that we can actually give in stage 2 type 1 diabetes to help delay the onset of clinical disease," she explained. This innovation provides a new avenue of care, offering hope for delaying the disease’s progression. 

Related: Teplizumab effectiveness in adolescents with newly diagnosed type 1 diabetes

"We’re seeing people who already have the disease," she noted. General pediatricians play a crucial role in screening for risk factors and initiating conversations about islet autoantibody testing. "That’s where the general pediatrician really comes in," she emphasized, as they can identify individuals with a family history of type 1 diabetes and refer them for further testing. 

In summary, Bruggeman’s session highlighted the growing importance of early detection and the use of new treatments, like teplizumab, in delaying the progression of type 1 diabetes. These updates underscore the vital role of pediatricians in identifying at-risk individuals and providing them with timely interventions. 

Brittany Bruggeman, MD, highlighted the ability to predict type 1 diabetes months to years in advance through islet autoantibodies, and how the pediatrician can play a role. 

Video Series

In this video discussion, David Turkewitz, MD, offers clinical pearls to reduce the risk of SIDS and reviews updated 2022 guidelines from the AAP. 

Reviewing the AAP's sudden infant death syndrome 2022 guidelines

David Turkewitz, MD, medical director of Newborn Nurseries at Allegheny Health Network in Pittsburgh, Pennsylvania, emphasized the critical role of pediatricians in educating families about strategies to prevent sudden infant death syndrome (SIDS) and sudden unexpected infant death (SUID). He underscored the importance of staying informed about the latest guidelines to better support families during well-infant visits. 

“Parents depend on pediatricians for advice to keep their children safe and healthy,” Turkewitz said. He noted that the 

2022 American Academy of Pediatrics (AAP) policy statement

 provides a comprehensive roadmap for preventing sleep-related infant deaths. 

“Prior to 1994, infant sleep-related deaths were all lumped into the category of sudden infant death syndrome,” Turkewitz explained. Advances in research and a better understanding of contributing factors have led to more nuanced classifications and targeted prevention strategies.

One critical recommendation highlighted in the guidelines is the importance of always placing infants on their backs to sleep. “Every baby is put on their back to sleep, every nap and for every evening. That one strategy… reduces SIDS more than 50%,” Turkewitz said.

He also emphasized the need for a safe sleep environment, advising parents to use a flat, firm surface for their infants. “While a soft mattress might be appropriate for an adult, it’s totally inappropriate for a baby,” he said.

Breastfeeding was another key preventative measure Turkewitz discussed, highlighting its benefits beyond infection reduction. “One of the more powerful benefits of breastfeeding is SIDS reduction,” he noted.

The guidelines also recommend room sharing, but not bed sharing, to create the safest sleep environment for infants. “The safest area for a baby to sleep is in a parent’s room,” Turkewitz said. "So again, just just having the baby sleep in another area, even if it's in an appropriate crib, dramatically increases its [SIDS risk]." 

Additionally, Turkewitz pointed to pacifier use starting at 2 weeks of age as an effective strategy. While the exact mechanism is uncertain, he said, “evidence-based literature is very clear cut” that pacifier use significantly reduces the risk of sleep-related deaths. 

Turkewitz cautioned against the use of unapproved devices or monitors, noting, “If it’s not government approved, don’t go there,” he advised.

He encouraged clinicians to familiarize themselves with the 2022 AAP guidelines, describing the document as “a great condensation of a tremendous amount of information.”

Moon RY, Carlin RF, Hand I. The task force on sudden infant death syndrome and the committee on fetus and newborn; Sleep-related infant deaths: Updated 2022 recommendations for reducing infant deaths in the sleep environment. 

. July 2022; 150 (1): e2022057990. 10.1542/peds.2022-057990 

In this video discussion, David Turkewitz, MD, offers clinical pearls to reduce the risk of SIDS and reviews the updated 2022 guidelines from the AAP. 

Reviewing the AAP's sudden infant death syndrome 2022 guidelines 

Rakesh Jain, MD, MPH, notes that with increasing ADHD trends, a newly-approved non-stimulant tool can help treat more patients. 

Pediatric ADHD trends and using clonidine hydrochloride as another treatment tool

 video interview, Rakesh Jain, MD, MPH, clinical professor, psychiatry, Texas Tech University School of Medicine, discussed the now-available, 

FDA-approved clonidine hydrochloride (ONYDA XR; Tris Pharma)

, and how having this tool can go a long way to helping more pediatric patients with attention-deficit/hyperactivity disorder (ADHD). 

This extended-release, liquid formulation is a non-stimulant treatment option that expands the toolkit for managing this increasingly prevalent condition. 

"Stimulants really do have a very good signal of effect. That effect is probably only for about 60 and if you’re lucky, 60 to 70% of children and adolescents," Jain explained. However, for those who do not respond to stimulants, treatment options have been limited. "I’ve had no once-a-day clonidine, FDA-approved treatment options available whatsoever, and now with it available, my choices to offer either as monotherapy, or sometimes in combination therapy, just dramatically went up." This broader range of options offers hope for improving academic, social, and family life for patients. 

ADHD prevalence is rising nationally, and the complexity of cases is increasing. Jain noted, "ADHD is on a march upwards, and not in a good way. And this isn’t a problem in [just] Texas or Massachusetts or Montana or California [or any one state]. The most recent Centers for Disease Control survey of ADHD in our community show that what you are seeing in your clinics is actually true. The numbers of males and females is going up." He emphasized that ADHD affects all demographics, transcending race and socioeconomic status. 

What Jain finds particularly concerning is the increasing complexity of ADHD presentations. "I’m seeing more complexities. I see more behavioral disruption. I see more difficulty with body weight. I see more difficulty with anger outbursts. I see more troubles with sleep difficulties," he said.

"It's almost as if the simple ADHD, whatever that is, doesn't present commonly. It's the more complex scenarios. Therein lies the reason why I'm so excited [to have] more treatment options that fit into a patient's life," said Jain.

Jain expressed enthusiasm for ONYDA XR’s convenience and accessibility. "Bid medications are hard to fit into a patient’s life. Once-a-day medications are easier, and a lot of my kids just don’t take pills or capsules for a variety of reasons. So having a liquid formulation that’s once a day and a non-stimulant on top of it, it is a cause for celebration by all clinicians, psychiatrists, primary care, general pediatrics." 

Jain broke down the once-daily treatment, in part saying "There's a lot of valuable assets this formulation has that fits nicely with the current clinical needs in psychiatry practices and pediatric practices," said Jain. "It is once a day. It is liquid, and that, of course, is really important to remember. It is to be used just once a day in a liquid formulation, and it can be used either as monotherapy, or it can be used in combination with stimulants."

Rakesh Jain, MD, MPH, notes that with increasing ADHD trends, a newly-available and FDA-approved non-stimulant tool can help treat more patients. 

Jain breaks down key benefits of clonidine hydrochloride (ONYDA XR; Tris Pharma) to treat ADHD among patients aged 6 years and older. 

Rakesh Jain, MD, MPH discusses once-daily clonidine hydrochloride (ONYDA XR) for ADHD

video interview, Rakesh Jain, MD, MPH, clinical professor, psychiatry, Texas Tech University School of Medicine, discussed the now-available,

 FDA-approved clonidine hydrochloride (ONYDA XR; Tris Pharma)

The once-a-day extended-release oral suspension with nighttime dosing, is approved to treat Attention-deficit/hyperactivity disorder (ADHD) as a monotherapy or as an adjunctive therapy to approved central nervous system (CNS) stimulant medications for patients aged 6 years and older. The oral solution was approved by the federal agency on May 29, 2024, and has been commercially available since October 1, 2024.

Clonidine hydrochloride is the first and only non-stimulant ADHD medication approved in the United States and the only approved non-stimulant ADHD medication with nighttime dosing.

"There's a lot of valuable assets this formulation has that fits nicely with the current clinical needs in psychiatry practices and pediatric practices," said Jain. "It is once a day. It is liquid, and that, of course, is really important to remember. It is to be used just once a day in a liquid formulation, and it can be used either as monotherapy, or it can be used in combination with stimulants."

For patients who do not adequately respond to stimulant medication or experience negative side effects, non-stimulant ADHD therapies are important. These treatments are increasingly used as an effective alternative to stimulant treatments, according to Tris.

According to the Centers for Disease Control and Prevention (CDC), the American Academy of Pediatrics (AAP) recommends medication and behavior therapy together for children 6 years of age and older with ADHD. The CDC stated between 70% and 80% of children with ADHD who take stimulant medications have fewer ADHD symptoms, though nonstimulants can last up to 24 hours.

"I still do believe stimulant medications are to be used in probably the majority of children and adolescents, but there's a substantial minority, perhaps as many as 30%, 35%, maybe even 40% where stimulants aren't appropriate," said Jain. "They're not appropriate for a variety of reasons. They either didn't work, or there are worries about appetite suppression, or there's worry about worsening the sleep of a child who already has having trouble with it, or there's a lot of agitation, and perhaps impulsivity and behavioral challenges, and perhaps the child has symptoms throughout the day. In those situations, the stimulant just isn't adequate." 

Fitch, J. FDA approves clonidine hydrochloride to treat ADHD in patients 6 years and up. 

. May 29, 2024. Accessed October 31, 2024. https://www.contemporarypediatrics.com/view/fda-approves-clonidine-hydrochloride-to-treat-adhd-in-patients-6-years-and-up 

Danielle Laraque-Arena, MD, FAAP

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