Other safety alerts
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| Australia: Product Alert: Vyvanse capsules multiple strength |
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The Therapeutic Goods Administration (TGA) announces that Takeda Pharmaceuticals Australia Pty Ltd is conducting a Product Alert for VYVANSE lisdexamfetamine dimesilate capsules in the following dosages: 20 mg, 30 mg, 40 mg, 50 mg, 60 mg, and 70 mg (various batches distributed since April 2024).
VYVANSE is indicated for the treatment of attention deficit hyperactivity disorder and the treatment of moderate to severe binge eating disorder when nonpharmacological treatment is unsuccessful or unavailable.
Takeda Pharmaceuticals Australia Pty Ltd has identified two minor typographical errors on the current VYVANSE packaging. The packaging states:
- "Each capsules contain..." whereas the correct wording should be "Each capsule contains..." and
- the company name includes the misspelled word "Pharmaceutivals", which should be "Pharmaceuticals".
These minor errors have led to customer complaints, concerns being raised in social media and an increase in reports of suspected adverse events. These minor typographical errors do not impact the quality of the Vyvanse capsules or patient safety. Patients should continue taking Vyvanse capsules according to their health professional's instructions. Anyone who is concerned in any way about the use of these products should consult their health professional.
Following social media commentary about this matter, there has been a recent increase in suspected adverse event reports submitted to the TGA regarding Vyvanse. The TGA is continuing its investigations into these reports, including reports of decreased effectiveness of Vyvanse. The TGA is working with Takeda to obtain more information, as well as undertaking independent testing in TGA’s own laboratories. As with any medicine, if the TGA finds any problems with safety or effectiveness relating to Vyvanse it will take regulatory action.
Please refer to the following website in TGA for details:
http://www.tga.gov.au/safety/market-actions/product-alert-vyvanse-capsules-multiple-strength
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. As confirmed by Takeda, the Australian pack in the TGA’s announcement is different from the registered pack of the product in Hong Kong and the Australian pack has never been imported into Hong Kong. As the TGA’s investigation in the suspected adverse event reports is ongoing, the DH will remain vigilant on its conclusion and any safety update of the drugs issued by other overseas drug regulatory authorities for consideration of any action deemed necessary.
Ends/Thursday, Apr 3, 2025
Issued at HKT 17:15
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