FDA Withdraws Certain Batches of Vyvanse Due to Efficacy Concerns

The U.S. Food and Drug Administration (FDA) has announced the withdrawal of multiple batches of Lisdexamfetamine Dimesylate, known commercially as Vyvanse, which is prescribed for Attention Deficit Hyperactivity Disorder (ADHD). This decision follows quality assessments indicating that the drug's efficacy may not meet the necessary standards.

The California State Board of Pharmacy reported that the medication did not pass a critical dissolution test, which ensures that the active ingredient is adequately absorbed in the body. They noted that the non-compliant capsules "may not provide the optimal therapeutic dose, potentially leading to reduced efficacy in patients."

While health authorities have stated that this issue does not pose an immediate health risk, it may hinder patients from achieving the full therapeutic benefits of the medication. The withdrawal affects various dosages, including 10, 20, 30, 40, 50, 60, and 70 mg.

ADHD is a behavioral condition characterized by difficulties in concentration, activity levels, and impulse control, commonly diagnosed in children but also present in adults. Vyvanse is one of the most frequently prescribed treatments for ADHD, with over 9 million prescriptions written in 2023.

Patients in possession of the affected batches are advised to consult their healthcare providers or pharmacies to arrange for a replacement or refund.