BEHAVIORAL HEALTH CORNER

According to data from the 2022 National Survey of Children’s Health (NSCH), 11.4% of children in the U.S. (7.1 million) have received an attention-deficit/hyperactivity disorder (ADHD) diagnosis and 10.5% (6.5 million) currently have ADHD. Estimates are for children 3 to 17 years of age and demonstrate about one million more children having ever received an ADHD diagnosis in 2022 compared with 2016. Most children currently diagnosed have at least one co-occurring disorder (77.9%) and more than half (58.1%) have moderate to severe ADHD. Almost a third (30.1%) of children with current ADHD have not received any ADHD-specific therapy; however, 44.4% had received behavioral therapy in the past year and 53.6% (3.4 million children) received ADHD medication. ADHD medication use was lower in children 3 to 5 years of age (23.6%) compared with children 6 to 11 years of age (56.9%) and adolescents aged 12 to 17 years (53.4%). Medication use was also greater in children with moderate (59.7%) and severe (77.9%) ADHD compared to children with mild ADHD (39.7%). Although the overall prevalence of children receiving behavioral therapy for ADHD in the prior year was lower than those who were taking medication, when behavioral therapy for ADHD was combined with any mental health counseling, the proportion of patients (58.3%) was comparable to the proportion receiving medication. ADHD is one of the most common neurodevelopmental disorders in pediatric patients in the U.S. and is an increasing public health concern.

Shortages of stimulants for the treatment of ADHD continue to be reported. Availability of generic methylphenidate HCl extended-release (ER) tablets is variable depending on the manufacturer. Brand-name Relexxi from Vertical as well as brand-name Concerta from Janssen are currently available. Shortages of the generic version of Vyvanse, lisdexamfetamine dimesylate capsules and chewable tablets persist. Brand-name Vyvanse capsules and chewable tablets remain available from Takeda. Generic amphetamine aspartate monohydrate, amphetamine sulfate, dextroamphetamine saccharate, and dextroamphetamine sulfate immediate release (IR) tablet shortages also continue from a few manufacturers. Brand name Adderall IR tablets from Teva are available.

CLINICAL CORNER

The FDA has issued an alert regarding labeling updates for glatiramer acetate injection (Copaxone, Glatopa) including a new warning that states using an autoinjector that is incompatible with a specific glatiramer acetate injection product can increase the risk for dosing errors (e.g., missed dose, partial dose). Some glatiramer acetate injection products can be administered using an optional compatible autoinjector; however, other products require injection using the prefilled syringe. Patients should confirm their autoinjector is compatible each time a new prescription for glatiramer acetate is received.

COVID-19 NOTABLE DEVELOPMENTS

The FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) convened on June 5, 2024 and voted unanimously for the 2024–2025 COVID-19 vaccines to contain the monovalent JN.1 lineage. Following the advisory meeting, on June 6, 2024, the FDA initially advised manufacturers of COVID-19 vaccines approved and authorized in the U.S. that beginning in fall 2024 the vaccines should be monovalent JN.1 vaccines. However, with continued monitoring of the circulating strains, the FDA subsequently determined the preferred JN.1-lineage for the 2024-2025 formula COVID-19 vaccine is the KP.2 strain to align more closely with currently circulating SARS-CoV-2 viruses. The change to KP.2 is not expected to delay availability of the vaccines.

FDA SPOTLIGHT

• The FDA has released the 11th annual report on drug shortages that is annually submitted to Congress. For the 2023 calendar year, 55 new drug shortages occurred and 236 were prevented.
• The FDA’s Peripheral and Central Nervous System Drugs Advisory Committee convened on June 10, 2024 to discuss the BLA for Eli Lilly’s investigational IV donanemab. The committee voted unanimously in favor of approval of the monoclonal antibody for the treatment of early Alzheimer’s disease.
• The FDA has announced the Oncology Center of Excellence Equity Program, a public health initiative intended to enhance access to clinical studies of oncology products for underrepresented populations. Targeted populations include racial and ethnic minorities, those who live in rural areas, sexual/gender minorities, and those with barriers (e.g., economic, linguistic, cultural) to health care services.
• The agency has launched a new campaign, “Prescribe with Confidence”, to aid in awareness about opioid use disorder (OUD) and facilitate access to evidence-based resources for HCPs. The intent of the campaign is to increase the number of HCPs who can recognize OUD and prescribe medication to treat OUD as appropriate.

WEIGHT MANAGEMENT CORNER

The American Heart Association (AHA) has published a Presidential Advisory forecasting the extent of cardiovascular disease (CVD) and stroke expected in the U.S. through 2050. It is estimated more than 61% of U.S. adults (> 184 million individuals) will likely have CVD including hypertension by 2050. Diabetes rates are expected to increase from roughly 16% to over 26%. Moreover, obesity rates are anticipated to increase from about 43% to over 60%, with adults 20–64 years of age, the hardest hit due to unhealthy diets. A third of children are expected to have obesity in 2050 with 2- to 5-year-olds predicted to have the largest increase in obesity. Lack of exercise and poor diets are each contributing factors in up to 60% of all children.

Long-term data from the SELECT trial (Semaglutide Effects on Heart Disease and Stroke in Patients with Overweight or Obesity; n=17,604) showed that with semaglutide 2.4 mg SC once weekly, weight loss continued to week 65 and then weight was sustained through week 208 (sustained average change, -10.18%). Furthermore, a secondary analysis on kidney outcomes in patients with overweight or obesity and established CVD without diabetes mellitus who were enrolled in the SELECT trial found that after a median follow-up of 182 weeks, the main composite kidney endpoint occurred in 1.8% of participants taking semaglutide 2.4 mg SC once weekly compared to 2.2% of patients on placebo (hazard ratio [HR], 0.78; 95% confidence interval [CI], 0.63 to 0.96; p=0.02). This composite endpoint was defined as death from kidney disease, initiation of chronic kidney replacement therapy, onset of persistent estimated glomerular filtration rate (eGFR) < 15 mL/min/1.73 m², persistent ≥ 50% reduction in eGFR versus baseline, or onset of persistent macroalbuminuria.

Shortages of GLP-1 agonists that are indicated for select patients as an adjunct to a reduced calorie diet and increased physical activity for chronic weight management are being reported by the FDA. Novo Nordisk’s liraglutide (Saxenda) has limited availability as does the liraglutide (Victoza) formulation indicated for select patients with type 2 diabetes mellitus (T2DM). Eli Lilly’s tirzepatide (Zepbound) has limited availability in some strengths, as does the tirzepatide (Mounjaro) formulation indicated as an adjunct to diet and exercise in adults with T2DM. The GLP-1 agonist dulaglutide (Trulicity), indicated for select patients with T2DM, also has limited availability in some strengths.