It was traditionally used to treat children—but lately, also the growing number of adults also being diagnosed with this disorder.
Adjusting to a new school year and routines can be tricky for any student, but for the estimated 7 million children in the U.S. diagnosed with attention-deficit hyperactivity disorder (ADHD), this time of year can bring a new wave of challenges—not to mention when certain medications designed to help are in short supply.
An estimated 6% of Americans have received an ADHD diagnosis, according to research published last month in Frontiers in Pharmacology, and around 33% use medications to help manage it. But ongoing shortages around ADHD medications in recent years have caused additional stress for many, with the research team noting there’s an “urgent need for healthcare policies that support individuals with ADHD amid shortages.”
These drug shortages have two main causes, according to a Medical News Today report: 1) a global growing need for these medications and 2) manufacturing issues. On top of that, drug recalls can impact supply as well, which could be the case for patients using one commonly prescribed option.
In a Tuesday morning report, the U.S. Food and Drug Administration (FDA) announced a nationwide recall for 8,544 bottles of Lisdexamfetamine Dimesylate capsules. The drug is a generic for brand names such as Vyvanse or Arynta.
Both adults and children (ages 6 years and older) may take lisdexamfetamine dimesylate to treat ADHD, according to the Mayo Clinic, though it may also be used to treat those with “moderate to severe” binge eating disorders. This recall specifically involves 40-milligram capsules, though the drug also comes in solution (liquid) or chewable tablet forms.
It’s one of the most common ADHD medications and can last 10 to 12 hours, per an American Academy of Pediatrics’ list. “As glasses help people focus their eyes to see, these medications help children with ADHD focus their thoughts better and ignore distractions,” says the organization.
The FDA provided the following product details:
- Lisdexamfetamine Dimesylate Capsules, 40 milligrams (mg)
- 100-count bottles
- Rx Only
- Lot #: 25280726A
- Expiration Date: 03/2027
- Distributed by: Lannett Company, Inc., Philadelphia, PA 19136.
- NDC (National Drug Code): 0527-4664-37
The problem, according to the FDA, has to do with a labeling mix-up that resulted in the wrong capsules ending up in the bottles. As stated in the report: “Labeling: Label Mix-up. A bottle labeled as Lisdexamphetamine Dimesylate Capsules 40mg, contained Lisdexamphetamine Dimesylate Capsules 30mg.” This could mean patients may have ingested 10 milligrams less than what their prescriber indicated.
The recall, first issued on August 11, was just designated Monday as a Class II event. The FDA describes a Class II recall as “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 named recalling firm, Lannett Company Inc. of Seymour, IN, has specialized in “high-quality, affordable generic pharmaceutical products” for more than 75 years, according to a company website. Late last year, the company was also named in a separate recall for lisdexamfetamine dimesylate.
Stay informed on health and wellness news with The Healthy by Reader’s Digest newsletter and follow The Healthy on Facebook and Instagram. Keep reading:
