Other safety alerts
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| Australia: Update on Vyvanse (lisdexamfetamine dimesilate) investigation |
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The Therapeutic Good Administration (TGA) announces that its investigation into concerns about Vyvanse’s potential lack of effectiveness, quality and safety found no issues of concern.
TGA began an investigation in March 2025 following an unexpected increase in the number of adverse event reports for Vyvanse (lisdexamfetamine dimesilate), including concerns about lack of effectiveness, quality and safety.
The testing found that all batches met the specified quality requirements.
The increased reporting started in March 2025 and appeared to be stimulated by social media commentary.
Vyvanse is used for the treatment of attention deficit hyperactivity disorder (ADHD), and moderate to severe binge eating disorder in adults when nonpharmacological treatment is unsuccessful or unavailable.
Please refer to the following website in TGA for details: http://www.tga.gov.au/safety/safety-alerts/update-vyvanse-lisdexamfetamine-dimesilate-investigation
In Hong Kong, Vyvanse Capsules 20mg (HK-66636), Vyvanse Capsules 30mg (HK-66637) and Vyvanse Capsules 50mg (HK-66638) are pharmaceutical products registered by Takeda Pharmaceuticals (Hong Kong) Limited (Takeda). The products are prescription-only medicines. So far, the Department of Health (DH) has not received any case of adverse drug reaction with regard to Vyvanse Capsule. Related news was previously issued by TGA and was posted on the Drug Office website on 03 Apr 2025.
Ends/ Saturday, September 27, 2025
Issued at HKT 12:00
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