Spike in ADHD medication adverse event reports

Australians are reporting a massively increased number of incidents involving one of the most commonly used ADHD medications.

Authorities are investigating a spike in incidents involving one of Australia’s most widely used ADHD medications.

Adverse event reports linked to medication Vyvanse have spiked massively this year, and the manufacturer says no changes in the chemical production have been made.

“The Therapeutic Goods Administration (TGA) is currently investigating a potential safety signal associated with Vyvanse, including independent testing of the medicine through the TGA Laboratories,” a spokesperson told NewsWire.

“The investigation is the result of a recent increase in adverse event notifications relating to concerns about the quality, safety, and reduced effectiveness of the drug.”

The TGA issued an alert about a typo on the Vyvanse label earlier this year. Picture: TGA

“There are no compliance signals currently under investigation for the facilities used in the manufacture of this product.”

A ‘signal’ is detection of a pattern which requires further investigation.

While not formally a pattern in the TGA’s eyes, reports of adverse events such as anxiety, ineffectiveness and insomnia have increased massively this year. There have also been 88 reports of issues with the medicines label, which was flagged by the TGA earlier this year for minor typos; however, one of the typos added an extra ‘S’ to the word capsule; “Each capsules contains 60mg lisdexamfetamine dimesilate”.

The TGA maintains the Database of Adverse Event Notifications, where people report issues with medications.

There have been 320 adverse events linked to Vyvanse in the first half of this year, compared to nine reports in the second half of 2024.

Inclusion in the database does not confirm the incident is caused by the medication.

Reports of ineffective Vyvanse have hit 150 so far this year, along with 88 reports of anxiety, and 73 reports that the therapeutic response has decreased.

Last year, 1.8m Vyvanse prescriptions were written in Australia, excluding Department of Veterans’ Affairs patients, over-the-counter drugs, private prescriptions and public inpatient prescriptions. Picture: NewsWire / Martin Ollman

Prescriptions of Vyvanse have been steadily increasing for the past few years. More than 958,000 scripts were written by public system health workers in 2022, rising to 1.4 million in 2023, and then 1.8m last year, government data shows.

In a statement, supplier Takeda Pharmaceuticals Australia said a change of manufacturing facility in 2024 did not alter the chemical composition of the medicine.

“There have been no changes to the formulation,” a Takeda spokesperson told the ABC.

Vyvanse was produced with strict quality controls, in line with Australia’s Therapeutics Goods Act, the spokesperson said.

The labelling typo did not affect the quality of the medication, they said.

Originally published as Spike in ADHD medication adverse event reports