Other safety alerts
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| Australia: Glyceryl trinitrate tablets (Anginine and Lycinate): Update - TGA investigation |
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The Therapeutic Goods Administration (TGA) announced that further to the information provided in the safety advisory, published 2 June 2016, testing by the TGA and the sponsor, Arrow Pharmaceuticals, has confirmed that the new formulation of glyceryl trinitrate (GTN) tablets for sublingual use are taking longer to disintegrate and is more difficult to break in half than the previous formulation.
GTN tablets are intended to dissolve within five minutes of placing under the tongue. However, the new formulation is taking longer than five minutes to disintegrate in laboratory testing. The lab results may not accurately reflect the time taken in the clinical setting, as reports received indicate that the disintegration is taking longer for some patients. To address this issue, Arrow Pharmaceuticals is working to reformulate the product. However, this will take some time.
There are no GTN tablets registered for use in Australia other than Anginine and Lycinate. If clinically appropriate, the TGA recommends healthcare professionals to consider switching patients who use GTN tablets to the GTN spray, Nitrolingual Pump Spray, noting that the spray delivers a different dose (400 micrograms) to the tablets (600 micrograms). If their patients continue to use GTN tablets, advise them to be aware that the tablets may not work within the expected timeframe and may be difficult to break in half. Advise patients to seek urgent medical attention if GTN tablets do not relieve their symptoms.
Please refer to the following website in TGA for details:
http://www.tga.gov.au/alert/glyceryl-trinitrate-tablets-anginine-and-lycinate-0
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.
Ends/ Thursday, July 28, 2016
Issued at HKT 15:00
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