Authorities in Australia are investigating a significant increase in adverse event reports associated with the ADHD medication Vyvanse. The Therapeutic Goods Administration (TGA) has noted a surge in notifications this year, prompting an inquiry into the safety and effectiveness of the drug. According to a TGA spokesperson, independent testing is being conducted to assess the situation.
The investigation follows a troubling rise in reports concerning the quality and therapeutic response of Vyvanse. As of now, the TGA has recorded 320 adverse events linked to the medication in the first half of this year, a stark rise from just nine reports during the second half of 2024. The reports include various concerns, such as anxiety, ineffectiveness, and insomnia.
In addition, there have been 88 notifications related to the medication’s labeling, which was previously flagged for minor typographical errors. One notable mistake involved the phrase, “Each capsules contains 60mg lisdexamfetamine dimesilate,” where an extra ‘S’ was mistakenly added. Despite these issues, the TGA indicated that there are currently no compliance concerns regarding the manufacturing facilities for Vyvanse.
Rising ADHD Cases and Medication Demand
The rise in adverse reports coincides with increasing rates of ADHD diagnoses in Australia. Ruth Limkin, founder of The Banyans Healthcare, highlighted a substantial jump in individuals seeking treatment for self-reported ADHD. “We’ve seen a 500 percent increase in people contacting us looking for treatment who have self-reported ADHD,” Limkin stated in an interview with Sky News Australia.
The demand for ADHD medications, particularly Vyvanse, has escalated dramatically. In 2022, over 958,000 prescriptions were issued by public health workers, rising to 1.4 million in 2023 and further to 1.8 million in 2024, as per government data. This rising trend raises questions about both the diagnosis process and the adequacy of current treatment options.
Takeda Pharmaceuticals Australia, the supplier of Vyvanse, clarified that there have been no changes in the chemical formulation of the medication despite a shift in manufacturing facilities in 2024. “There have been no changes to the formulation,” a spokesperson for Takeda stated. The company reassured the public that Vyvanse is produced under strict quality controls in accordance with Australia’s Therapeutics Goods Act.
While the TGA’s Database of Adverse Event Notifications serves as a platform for individuals to report medication-related issues, it is important to note that inclusion in the database does not confirm a direct cause-and-effect relationship. Reports of ineffective treatment with Vyvanse have reached 150 this year, alongside 88 reports of anxiety and 73 notifications indicating a decrease in therapeutic response.
As the investigation continues, the TGA remains vigilant in monitoring the safety of Vyvanse, striving to ensure that patients receive effective and safe treatment options. The rising numbers of adverse event reports will likely intensify scrutiny on the medication and its manufacturing process.
