Safety advice on particular drugs or classes of drugs
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| Canada: Health Canada Endorsed Important Safety Information on EFFIENT (prasugrel hydrochloride) |
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Eli Lilly Canada Inc. in collaboration with Health Canada inform healthcare professional regarding the important safety information about EFFIENT® (prasugrel hydrochloride), an antiplatelet agent indicated for the prevention of atherothrombotic events in patients with acute coronary syndromes.
The information concerns the indication related to UA (unstable angina) or NSTEMI (non-ST-segment elevation myocardial infarction).
A recent study (ACCOAST) showed an increased risk of bleeding with the use of half loading dose (30 mg) of EFFIENT® prior to coronary angiography followed by the second half loading dose (30mg) at the time of PCI compared to taking the full approved loading dose (60 mg) at the time of PCI.
In UA/NSTEMI patients, when coronary angiography is performed within 48 hours after admission, the loading dose of EFFIENT® should generally be given at the time of PCI in order to minimize the risk of bleeding.
UA/NSTEMI patients should generally be administered a 60 mg loading dose of EFFIENT® at the time of PCI, followed by a 10 mg maintenance dose.
Please refer to the following website in Health Canada for details:
http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/../37611a-eng.php
In Hong Kong, there are two pharmaceutical products namely Effient Tab 5mg (HK-59090) and Effient Tab 10mg (HK-59091) containing prasugrel and they are prescription-only medicine. In view of the recommendation of Health Canada, a letter to healthcare professionals will be issued and the matter will be discussed in the coming meeting of the Registration Committee of the Pharmacy and Poisons Board.
Ends/ Saturday, January 18, 2014
Issued at HKT 12:00
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