ADR that result in revision of patient information
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| Australia: Ivabradine (Coralan): Safety advisory - risk of cardiovascular events in patients with angina |
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Consumers and health professionals are advised that the TGA has completed a safety review of ivabradine, marketed as Coralan. Subsequently, the Product Information (PI) for ivabradine has been updated to reduce the risk of cardiovascular events in patients who take the medicine for angina.
Ivabradine is a heart rate lowering agent that can be used to treat the symptoms of chronic stable angina or treatment of symptomatic chronic heart failure.
The changes to the PI, which are based on a phase III clinical study, include updated indications and contraindications and other information to reduce the risk of cardiovascular events in patients with angina. In particular, patients who take ivabradine for angina must now have a resting heart rate equal to or above 70 beats per minute (bpm) prior to treatment. This has been increased from 60 bpm.
The PI has been updated to include additional medicines that ivabradine should not be taken in combination with, including diltiazem and verapamil, which are used to treat high blood pressure or angina. An existing warning regarding a potential interaction with grapefruit juice has also been strengthened to advise that drinking grapefruit juice should be avoided (rather than 'restricted').
The TGA advises healthcare professionals that if they are treating a patient who is taking ivabradine for angina, they should review the updated indications, contraindications, precautions and interactions sections. Ivabradine must not be used in patients who have a pre-treatment resting heart rate below 70 bpm or concomitantly with potent cytochrome P450 3A4 [CYP3A4] inhibitors or moderate CYP3A4 inhibitors with heart rate reducing properties. They should educate patients regarding the signs and symptoms of the cardiovascular events identified in the PI and instruct them to seek medical attention if any are suspected.
Please refer to the following website in TGA for details:
http://www.tga.gov.au/alert/ivabradine-coralan
In Hong Kong, there are two registered pharmaceutical products containing ivabradine, namely Coralan Tab 7.5mg (HK-55438) and Coralan Tab 5mg (HK-55439). Both are prescription-only medicines registered by Servier Hong Kong Ltd (Servier). Related news has been released by the TGA and the EMA, and was posted on the Drug Office website on 9 May, 23 June, 8 November and 22 November 2014. Servier has applied to the Department of Health (DH) to include the relevant information in the package insert of the products, and the application is under evaluation. So far, the DH has not received any adverse drug reaction report on ivabradine. In view of the TGA's announcement on update of PI, letters to healthcare professionals will be issued to draw their attention to the updates, and the matter will be discussed in the meeting of the Registration Committee of the Pharmacy and Poisons Board.
Ends/ Thursday, July 09, 2015
Issued at HKT 13:00
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