Other safety alerts
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| Australia: Safety advisory: Glyceryl trinitrate tablets (Anginine and Lycinate) - reports of longer than expected time to dissolve and difficulty breaking tablets |
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The Therapeutic Goods Administration (TGA) advised consumers and health professionals that the TGA is investigating reports that glyceryl trinitrate (GTN) tablets, sold in Australia under the brand names Anginine and Lycinate, are taking longer than expected to dissolve under some patients' tongues, which may impact patient safety. Some reports have also indicated that the tablets are difficult to break in half.
GTN tablets, which are given under the tongue, are used to treat acute angina pectoris (chest pain caused by coronary heart disease). The tablets are used in acute healthcare settings, such as hospitals and ambulances, but can also be used by patients at home. If a GTN tablet does not dissolve properly or quickly enough, the patient may not receive adequate or timely therapy, which could lead to other serious health consequences.
Both Anginine and Lycinate share the same formulation, including the new formulation that is available in a circular tablet (the old formulation was a square tablet).
To date, the reports of longer than expected time to dissolve and difficulty breaking tablets in half have related only to the new formulation of GTN tablets. The TGA is working with the current sponsor, Arrow Pharmaceuticals and previous sponsor, Aspen Pharma, to investigate this issue. The affected products are not being recalled at this time while the TGA continues to investigate the issue.
Please refer to the following website in TGA for details:
http://www.tga.gov.au/alert/glyceryl-trinitrate-tablets-anginine-and-lycinate
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.
Ends/ Thursday, June 02, 2016
Issued at HKT 13:00
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