Safety advice on particular drugs or classes of drugs
|
| |
| Australia: Glyceryl trinitrate tablets (Anginine and Lycinate): Alternative product and potential medicine shortage |
| |
This alert updates information previously provided in TGA safety advisories published on 27 July 2016 and 2 June 2016 regarding a new formulation of glyceryl trinitrate (GTN) tablets for sublingual use that were taking longer than usual to disintegrate and were more difficult to break in half.
Consumers and health professionals are advised that the TGA has approved an application to supply an alternative product, Nitrostat tablets. However, the availability of this alternative product may not be sufficient to meet demand at this time, so the TGA is continuing to work with industry to address this issue.
To avoid a potential medicine shortage, the current formulation of Anginine and Lycinate tablets are not being recalled at the present time. Please note, the previous square-shaped formulation is not affected by this issue and that the sponsor of Anginine and Lycinate tablets, Arrow Pharmaceuticals, is working to reformulate the product.
Please refer to the following website in TGA for details:
http://www.tga.gov.au/alert/glyceryl-trinitrate-tablets
In Hong Kong, both Anginine and Lycinate are not registered pharmaceutical products, and there is no registered pharmaceutical product containing glyceryl trinitrate which is manufactured by Arrow Pharmaceuticals or Aspen Pharma. Related news was previously issued by the TGA, and was posted on the Drug Office website on 2 June 2016 and 28 Jul 2016.
Ends/Saturday, February 4, 2017
Issued at HKT 12:00
|
| |
|
