Reports of adverse events linked to the ADHD medication Vyvanse have surged dramatically in Australia this year, prompting an investigation by the Therapeutic Goods Administration (TGA). The agency is examining a potential safety signal associated with the drug, following a notable increase in notifications regarding its quality, safety, and effectiveness.
According to a TGA spokesperson, the investigation includes independent testing of Vyvanse at TGA Laboratories. “There are no compliance signals currently under investigation for the facilities used in the manufacture of this product,” the spokesperson stated. A ‘signal’ refers to a pattern that necessitates further scrutiny. Although the TGA has not recognized a formal pattern, adverse events such as anxiety, ineffectiveness, and insomnia have been reported at significantly higher rates this year.
In addition to the health concerns, the TGA identified 88 reports concerning labeling issues. Earlier this year, the agency flagged a minor typo on the medication’s label, which added an extra ‘S’ to the word “capsule.” The corrected label states: “Each capsule contains 60mg lisdexamfetamine dimesilate.”
Rising ADHD Diagnoses and Prescription Rates
The increase in Vyvanse adverse event reports coincides with a sharp rise in self-diagnosed ADHD cases in Australia. Ruth Limkin, Founder of Banyans Healthcare, noted a staggering 500 percent increase in inquiries from individuals self-reporting ADHD. “One of the things we’ve noticed at The Banyans is that we’ve seen a 500 percent increase in people contacting us looking for treatment who have self-reported ADHD,” Limkin shared in an interview with Sky News Australia.
Data from government sources shows that prescriptions for Vyvanse have also risen steadily over the past few years. In 2022, more than 958,000 prescriptions were written by public health workers, increasing to 1.4 million in 2023 and reaching 1.8 million in 2024.
The TGA maintains the Database of Adverse Event Notifications, which allows individuals to report issues with medications. There were 320 adverse events linked to Vyvanse in the first half of 2024, a stark contrast to just nine reports in the second half of 2023. Of these, there have been 150 reports of the medication being ineffective, 88 reports of anxiety, and 73 reports indicating a decrease in therapeutic response.
Manufacturer Responds to Concerns
In response to the growing concerns, Takeda Pharmaceuticals Australia emphasized that a change in manufacturing facility in 2024 did not alter the chemical composition of Vyvanse. “There have been no changes to the formulation,” a Takeda spokesperson stated. They asserted that Vyvanse is produced under strict quality controls in compliance with Australia’s Therapeutics Goods Act. The spokesperson also clarified that the labeling typo did not compromise the quality of the medication.
As the investigation continues, both healthcare professionals and patients are urged to report any adverse events associated with Vyvanse. The TGA’s ongoing investigation aims to ensure the safety and efficacy of this widely used medication amid rising concerns.
