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Medically reviewed by Carmen Pope, BPharm. Last updated on Oct 10, 2024. By Ernie Mundell HealthDay Reporter

More than 15.5 million U.S. adults have been diagnosed with ADHD, and nearly three-quarters of those taking medication to treat it say drug shortages are hampering their ability to get help, a new report finds.

According to the U.S. Centers for Disease Control and Prevention (CDC), a national survey conducted last fall found that 6% of adults have a current diagnosis of attention deficit hyperactivity disorder (ADHD), and just over half (about 56%) received that diagnosis in adulthood.

Many aren’t receiving treatment to control the inattention, impulsivity and hyperactivity that characterize the condition.

“Approximately one half of adults (50.4%) with ADHD were prescribed medications to treat their ADHD during the previous 12 months,” noted a team led by Brooke Staley of the CDC’s National Center on Birth Defects and Developmental Disabilities.

The vast majority of drug treatments involved stimulant medications such as Ritalin, Vyvanse, Concerta or Adderall. However, recent shortages of these meds are affecting most adult ADHD patients, the study also found.

“Among adults who reported taking a stimulant medication, 71.5% reported difficulty getting their ADHD prescription filled during the previous 12 months because their medication was not available,” the CDC team said.

That can lead to real problems for patients, because proper medication is tied to “reduced social and emotional impairment, unintentional injuries, substance use disorders, and the risk of death to unnatural causes,” the report’s authors said.

Folks who can’t get their ADHD medications through usual means might also try to buy them off the Internet or elsewhere, “increasing their risk for overdose because of the prevalence of counterfeit pills in the illegal drug market, which might contain unexpected substances such as fentanyl,” Staley’s team added.

ADHD drug shortages have plagued U.S. patients for years. The FDA first warned of a shortage of Teva Pharmaceutical Industries’ Adderall medication in October 2022, as the company grappled with manufacturing delays.

In September, the U.S. Drug Enforcement Administration gave drugmaker Takeda, the maker of Vyvanse, the green light to make more of the medication as a shortage of ADHD drugs continues.

Telehealth is a relatively new avenue some adults with ADHD might turn to as they seek out needed care. The new report noted that close to half (46%) of adults with ADHD said they had used such services, including nearly 1 in 10 patients who said they received their ADHD diagnosis via telehealth services.

About 30% said they had gotten help accessing ADHD meds and/or counseling in this way, as well.

The new findings were published Oct. 10 in the CDC journal Morbidity and Mortality Weekly Report.

https://www.drugs.com/news/6-u-s-adults-have-adhd-shortages-affecting-121785.html

FDA Approves Otulfi™, a Biosimilar to Stelara®

Fresenius Kabi, and Formycon AG, announced the U.S. Food and Drug Administration (FDA) approved Otulfi™ (ustekinumab-aauz), its ustekinumab biosimilar referencing Stelara®. Otulfi™ is approved for the treatment of Crohn’s disease, ulcerative colitis, moderate to severe plaque psoriasis and active psoriatic arthritis.

• Ustekinumab is a human monoclonal antibody that targets the cytokines interleukin-12 and interleukin-23 which play an important role in inflammatory and immune responses.
• Otulfi™ demonstrated comparable efficacy, safety, pharmacokinetics, and immunogenicity to the reference drug Stelara® in patients with moderate to severe psoriasis vulgaris (plaque psoriasis).
• Otulfi™ was approved for both subcutaneous and intravenous formulations which will offer a comprehensive, alternative treatment solution for health care professionals and patients treated with ustekinumab in the U.S.
  Source: Fresenius Kabi

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FDA Approves Flyrcado Radioactive Diagnostic for Enhanced Diagnosis of Coronary Artery Disease

GE HealthCare announced the U.S. Food and Drug Administration (FDA) granted approval of Flyrcado (flurpiridaz F-18) injection, a first-of-its-kind positron emission tomography myocardial perfusion imaging (PET MPI) agent, for the detection of coronary artery disease (CAD).

• Indicated for patients with known or suspected CAD, Flyrcado delivers higher diagnostic efficacy compared to single-photon emission computed tomography (SPECT) MPI, the predominant procedure used in nuclear cardiology today.
• Flyrcado, which can be manufactured in an offsite pharmacy and delivered as a ready-to-use unit dose, has the potential to expand clinician and patient access to PET MPI, including improving diagnostic accuracy in difficult-to-image patients such as those with a high body mass index (BMI) and women.

Source: GE HealthCare

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The FDA is alerting patients, caregivers, and health care professionals that Oxbryta (voxelotor) is being voluntarily withdrawn from the market by the manufacturer due to safety concerns. Health care professionals should stop prescribing Oxbryta. Patients and caregivers should contact their health care professional about stopping Oxbryta and starting another treatment option.

In postmarketing clinical trials of Oxbryta, Pfizer reported a higher rate of vaso-occlusive crisis (severe pain caused by sickled red blood cells blocking blood flow and oxygen delivery to tissues) in patients with sicklecell disease receiving Oxbryta compared to placebo. There were also more deaths in the Oxbryta treatment group as compared to the placebo group in these postmarketing studies. Pfizer also observed a higher rate of vaso-occlusive crisis in patients with sickle cell disease receiving Oxbryta in two real world registry studies.

Pfizer Inc., the manufacturer of Oxbryta, announced it is voluntarily withdrawing the medication from the market, ceasing distribution, and discontinuing all active clinical trials and expanded access programs for Oxbryta because recent data indicate the benefit of Oxbryta does not outweigh the risks for the sickle cell patient population.

Source: FDA

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FDA Approves Aqneursa for the Treatment of Niemann-Pick Disease Type C
IntraBio Inc. announced the U.S. Food and Drug Administration (FDA) approved Aqneursa (levacetylleucine) for the treatment of neurological manifestations of Niemann-Pick disease type C (NPC) in adults and pediatric patients weighing ≥15kg.

• Aqneursa is the only FDA-approved, stand-alone therapy indicated for the treatment of NPC. Until now, current treatment approaches have not addressed the debilitating effects of NPC on patients’ daily lives.
• NPC is a rare, inherited lysosomal disease that occurs in about 1 in 100,000 live births. Patients with NPC typically experience systemic, neurological, and psychiatric symptoms that can be debilitating and significantly impact functional abilities.
  Source: IntraBio Inc.

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FDA Approves Miplyffa for the Treatment of Niemann-Pick Disease Type C

Zevra Therapeutics, Inc. announced that the U.S. Food and Drug Administration (FDA) has approved Miplyffa™ (arimoclomol) capsules as an orally delivered treatment for Niemann-Pick disease type C (NPC).

• The first NPC drug approved by the FDA, Miplyffa is indicated for use in combination with miglustat for the treatment of neurological manifestations of NPC in adult and pediatric patients 2 years of age and older.
• Those living with NPC experience progressive physical and cognitive limitations, with key neurological impairments presenting in speech, cognition, swallowing, ambulation, and fine motor skills.
  Source: Zevra Therapeutics, Inc.

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FDA Approves Ocrevus Zunovo. A Twice-A-Year Subcutaneous Injection for People With Relapsing and Progressive Multiple Sclerosis

Genentech, announced the U.S. Food and Drug Administration (FDA) approved Ocrevus Zunovo (ocrelizumab & hyaluronidase-ocsq) for the treatment of relapsing multiple sclerosis (RMS) and primary progressive multiple sclerosis (PPMS).

• Ocrevus Zunovo is the first and only twice-a-year, healthcare professional (HCP) administered approximately 10-minute subcutaneous (SC) injection approved for both these forms of multiple sclerosis, giving people living with MS more treatment options.
• Ocrevus Zunovo gives patients and providers another option for receiving Ocrevus, with a decade of treatment for multiple sclerosis.
  Source: Genentech

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FDA Approves Ebglyss for the Treatment of Atopic Dermatitis

Eli Lilly and Company announced the U.S. Food and Drug Administration (FDA) approved Ebglyss (lebrikizumab-lbkz), a targeted IL-13 inhibitor, for the treatment of adults and children 12 years of age and older who weigh at least 88 pounds (40 kg) with moderate to-severe atopic dermatitis (eczema) that is not well controlled despite treatment with topical prescription therapies.

• Eczema inflammation under the skin can lead to symptoms seen and felt on the outside. Ebglyss works by targeting eczema inflammation throughout the body that can lead to dry, itchy, and irritated skin.
  Source: Eli Lilly and Company

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