Many families, teachers, and pediatric healthcare providers know that attention deficit hyperactivity disorder (ADHD) is the most frequently diagnosed behavioral disorder in children.
The prevalence of ADHD among adults is also gaining awareness.
The Centers for Disease Control and Prevention (CDC) estimates that in the United States, 7 million children between the ages of three and 17 years, and 15.5 million adults, have been diagnosed with ADHD.
Experts suggest this prescription is often doctors’ first choice for ADHD treatment, but the government says ingredient doses varied from pill to pill.
Data on ADHD treatment varies by state, but the CDC also estimates that between 38% and 81% of children who have been diagnosed with ADHD take medication as part of their treatments, as do approximately one-third of diagnosed adults.
Recently, the U.S. Food and Drug Administration (FDA) announced that pharmaceutical manufacturer Lannet Company issued a voluntary, nationwide recall of one particular generic ADHD medication: Lisdexamfetamine dimesylate capsules.
The National Institutes of Health calls lisdexamfetamine dimesylate a “first-line therapy” for ADHD, or in other words, it’s often doctors’ primary approach in treating the symptoms.
Brand names for the drug include Elvanse and Vyvanse.
The Mayo Clinic explains how the medication works: “Lisdexamfetamine dimesylate increases attention and decreases restlessness in children and adults who are overactive, cannot concentrate for very long, or are easily distracted and impulsive.
This medicine is used as part of a total treatment program that also includes social, educational, and psychological treatment.”
One 2019 pharmacological review suggested that in some cases, lisdexamfetamine dimesylate may show stronger effect than Adderall and Ritalin, but only a licensed healthcare professional can determine which of these may be most appropriate for a particular patient.
In its notice, the FDA warned that 1,608 bottles of lisdexamfetamine dimesylate capsules had failed to meet quality standards and were originally recalled on October 25, 2024. In particular, the prescription medication was found to have substandard Content Uniformity (CU).
This means that when samples of the product were randomly collected and tested, the dosages varied too much, suggesting inadequate mixing. Patients taking this drug may get too much or too little of its active ingredients.
Last week, on December 5, 2024, the FDA issued an update designating the incident as a Class II recall. This represents “a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote,” the FDA writes.
Lisdexamfetamine dimesylate capsules, classified as central nervous system (CNS) stimulants, are approved for use by adults and children aged 6 and up. The product details on the recalled drug are the following:
