recently approved medications for children and adolescents

INTRODUCTION: The dextroamphetamine transdermal system (d-ATS) is a stimulant patch recently approved by the United States (U.S.) Food and Drug Administration for the treatment of attention-deficit/hyperactivity disorder (ADHD). AREAS COVERED: The composition of the d-ATS, pharmacokinetics, and metabolism are presented along with data from dermal trials evaluating the tolerability of patch application at various skin sites. Efficacy and safety data from a laboratory classroom study in children and adolescents including effect sizes are assessed...

INTRODUCTION: According to the Global Climate Risk Index, Pakistan is ranked as the fifth-most vulnerable country to climate change. Most recently, during June-August 2022, heavy torrential rains coupled with riverine, urban, and flash flooding led to an unprecedented disaster in Pakistan. Around thirty-three million people were affected by the floods. More than 2 million houses were damaged, leaving approximately 8 million displaced and approximately 600,000 people in relief camps. Among those, 8...

Metabolic dysfunction-associated steatotic liver disease (MASLD), previously known as nonalcoholic fatty liver disease (NAFLD), is the main cause of chronic liver disease in children and adolescents. Indeed, epidemiological studies have shown that MASLD affects up to 40% of children with obesity. Despite the recent approval of medications that target weight loss in adolescents that could have benefits on pediatric MASLD, lifestyle interventions, such as diet and exercise, remain the mainstay of our therapeutic approach...

Pediatric obesity is a highly prevalent chronic disease, which has traditionally been treated with lifestyle therapy alone. Yet for many youth, lifestyle intervention as a monotherapy is often insufficient for achieving clinically significant and durable BMI reduction. While metabolic/bariatric surgery achieves robust and long-lasting outcomes, it is neither widely accessible nor wanted by most pediatric patients and families. In the past 3 years, this treatment gap between lifestyle therapy and metabolic/bariatric surgery has been filled with a number of landmark clinical trials examining the safety and efficacy of anti-obesity medication (AOM) for use in children and adolescents...

According to the Centers for Disease Control and Prevention (CDC), 100,306 drug overdose deaths occurred in the US during a 12-month period ending in April 2021. Opioids were involved in 75% of these related deaths. Opioid Use Disorder (OUD) is a constantly evolving public health crisis with potentially lethal consequences. In 2017, 900 adolescents began to misuse opioids every day. Nearly 10% of high school seniors reported using opioids nonmedically. Additionally, the incidence for hospitalizations for adolescents among children 1-19 years of age increased nearly 2-fold from 1997 to 2012...

BACKGROUND: Dupilumab is approved for moderate-severe atopic dermatitis (AD) in patients aged ≥6 months by the US Food and Drug Administration and Health Canada; however, there are little real-world data because providers have limited practical experience with this recently approved therapy. OBJECTIVES: To describe the real-world effectiveness and safety in patients aged <12 years with moderate-severe AD currently receiving or previously having received dupilumab...

INTRODUCTION: Children and adolescents with Crohn's disease present unique challenges due to extensive disease at diagnosis and the effect of bowel inflammation on growth. Historical approaches with corticosteroids and immunomodulators are far less effective than early treatment with anti-TNF biologics. AREAS COVERED: This review covers recent literature delineating the crucial role of early anti-TNF therapy in the treatment of moderate- to- severe Crohn's disease in children and adolescents...

Juvenile idiopathic arthritis (JIA) is a common form of arthritis that occurs in children, typically with an onset before the age of 16 years. It can affect joints in any part of the body. As per the International League of Rheumatology, JIA is classified into systemic arthritis, oligoarthritis, extended oligoarthritis, polyarthritis (rheumatoid factor positive), polyarthritis (rheumatoid factor negative), enthesitis-related arthritis (ERA), juvenile psoriatic arthritis (JPsA), and other arthritis . JIA is treated with disease-modifying antirheumatic medications (DMARDs), which include both nonbiologic agents like methotrexate (MTX) and biologic agents like inhibitors of tumor necrosis factor-alpha, interleukin-1 (IL-1), IL-6, and T-cell co-stimulation modulators...

Juvenile idiopathic arthritis (JIA), the most common chronic rheumatologic condition in childhood, remains a cause of significant morbidity, particularly in those with spondyloarthropathy, including psoriatic arthritis (PsA) and enthesitis-related arthritis (ERA). While secukinumab was recently approved for the treatment of children and adolescents with ERA and PsA, there is limited published data on its use in JIA, particularly in refractory cases, despite its efficacy in the treatment of adult arthritis. We aim to examine the use of this therapy in JIA in a single pediatric rheumatology center...

INTRODUCTION: Pediatric attention-deficit disorder (ADHD) impacts a significant percentage of the population world-wide. Pharmacologic treatments have been shown to be safe and effective for managing symptoms. Various medication formulations exist, and new medication agents are continually approved each year. AREAS COVERED: This article offers an overview of ADHD, an overview of both stimulant and non-stimulant medication options as well as an overview of stimulant misuse...

PURPOSE OF REVIEW: Conventional treatments of atopic dermatitis have been inadequate, especially in patients with moderate-to-severe disease. RECENT FINDINGS: In the past 5 years, four immunomodulators have been approved for the treatment of atopic dermatitis in children. These include dupilumab, ruxolitinib, upadacitinib, and abrocitinib. The review summarizes the pivotal phase 3 trials of these medications. SUMMARY: The newer immunomodulators have transformed the treatment of atopic dermatitis, particularly in patients with moderate-to-severe disease...

INTRODUCTION: Different disease-modifying therapies (DMTs) have been developed to slow down the progression of pediatric multiple sclerosis (MS). Teriflunomide is one such DMT that has recently been approved for use in pediatric MS in the European Union. AREAS COVERED: The article provides an introduction to the mechanism of action of teriflunomide, reviews the clinical trials conducted on the safety and efficacy of the drug, and the optimal dosing and monitoring strategies...

Autism spectrum disorder (ASD) is a neurodevelopmental disorder that affects 0.6%-1.7% of children. The etiology of autism is hypothesized to include both biological and environmental factors (Watts, 2008). In addition to the core symptoms of social-communication delay and restricted, repetitive interests, co-occurring irritability/aggression, hyperactivity, and insomnia negatively impact adaptive functioning and quality of life of patients and families. Despite years of effort, no pharmacologic agent has been found that targets the core symptoms of ASD...

OBJECTIVE: Stakeholders met to address persistent challenges facing development of therapeutics for polyarticular JIA (pJIA), which result in fewer approved therapies for children with pJIA than adults with rheumatoid arthritis (RA) and long lag times from adult RA approval to pediatric labeling. Ensuring new medications are authorized in a timely manner to meet the needs of JIA patients worldwide is critically important to multiple stakeholders. METHODS: The FDA in collaboration with University of Maryland Center for Regulatory Science and Innovation (MCERSI) held a public workshop entitled "Accelerating Drug Development for polyarticular juvenile idiopathic arthritis (pJIA) on October 2, 2019, to address challenges surrounding access to new medications for children and adolescents with pJIA...

The worldwide prevalence of obesity has been increasing progressively over the past few decades and is predicted to continue to rise in coming years. Unfortunately, this epidemic is also affecting increasing rates of children and adolescents, posing a serious global health concern. Increased adiposity is associated with various comorbidities and increased mortality risk. Conversely, weight loss and chronic weight management are associated with improvements in overall morbidity and mortality. The pathophysiology of obesity is multifactorial with complex interactions between genetic and environmental factors...

Tuberous sclerosis (TSC) epilepsy includes infantile spasms and focal seizures before the age of 2 years, whereas focal seizures are predominant over 2 years and generalized seizures may occasionally be part of Lennox-Gastaut syndrome. The better and earlier the seizure control, the better the child's subsequent cognitive and behavioral prognosis. As for epilepsy of other causes, therapeutic options depend on the type of seizure/epilepsy, age and drug resistance, but there are significant specificities for TSC...

Disruptive behaviour disorders (DBDs) in childhood include conduct disorder (CD) and oppositional defiant disorder (ODD). Though psychological therapies are considered to be the first-line treatment for DBDs, many patients require adjunctive pharmacotherapy for the control of specific symptoms, such as aggression. Three prior systematic reviews have examined the evidence for the use of antipsychotics in DBDs and have concluded that their efficacy is marginal and limited by adverse effects. This paper has two objectives: (i) to summarize the findings of existing systematic reviews of antipsychotics for the management of DBDs in children and adolescents (2012-2017), and (ii) to provide an update to these reviews by examining recent clinical trials of antipsychotics in this population, published in the period from 2 January 2017 to 10 October 2022...

Sickle-cell disease (SCD) is an inherited hemoglobinopathy, causing lifelong complications such as painful vaso-occlusive episodes, acute chest syndrome, stroke, chronic anemia, and end-organ damage, with negative effects on quality of life and life expectancy. Within the last five years, three new treatments have been approved: L-glutamine in 2017 and crizanlizumab and voxelotor in 2019. We conducted a literature search of these three medications, and of the 31 articles meeting inclusion criteria, 6 studied L-glutamine, 9 crizanlizumab, and 16 voxelotor...

BACKGROUND: The recent second wave and the latest third wave of coronavirus disease 2019 (COVID-19) in India caused havoc on health infrastructure. However, there is a scarcity of studies from India and abroad that compare the second and third waves of the COVID-19 pandemic. We aimed to assess the factors like age, sex, and death comparison among diagnostically proven COVID-19 patients of the Meerut district in both waves. METHODOLOGY: A total of 297554 samples during the second wave (1st March 2021 to 30th  June 2021) and 240655 during the third wave (1st January 2022 to 30th April 2022) were tested for reverse transcription polymerase chain reaction (RT-PCR) in the Department of Microbiology, Lala Lajpat Rai Medical College, using The Indian Council of Medical Research (ICMR) approved RT-PCR testing kits...

CONTEXT: Pediatric obesity is a serious health problem in the United States. While lifestyle modification therapy with dietary changes and increased physical activity are integral for the prevention and treatment of mild to moderate obesity in youth, only a modest effect on sustained weight reduction is observed in children and young adults with severe obesity. This underscores the need for additional evidence-based interventions for children and adolescents with severe obesity, including pharmacotherapy, before considering invasive procedures such as bariatric surgery...