ADR that result in revision of patient information
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| Singapore: Increased risk of serious bleeding in patients with unstable angina (UA)/non-ST-elevation myocardial infarction (NSTEMI) when Effient is administered prior to diagnostic coronary angiography |
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Eli Lily and Company would like to inform healthcare professionals of new recommendation on the administration of Effient (prasugrel) in patients undergoing percutaneous coronary intervention (PCI). In UA/NSTEMI patients, when coronary angiography is performed within 48 hours after admission, the loading dose of Effient should only be given at the time of PCI in order to minimize the risk of bleeding. This is based on the outcome of a recently completed clinical study in NSTEMI patients. The use of an initial loading dose prior to coronary angiography followed by an additional dose at the time of PCI is associated with an increased risk of bleeding, as compared with a single prasugrel loading dose at the time of PCI. The package inserts of Effient have been updated to capture this new safety information.
Please refer to the following website in HSA for details:
http://www.hsa.gov.sg/publish/hsaportal/../DHCPL.html
In Hong Kong, there are two registered pharmaceutical products containing prasugrel, namely Effient Tab 5mg (HK-59090) and Effient Tab 10mg (HK-59091). Both products are prescription-only medicines registered by Eli Lilly Asia, Inc. (Eli Lilly). So far, the Department of Health (DH) has not received any adverse drug reaction report on bleeding in patients undergoing percutaneous coronary intervention in connection with the drug. Eli Lilly has already updated the product insert to include a special warnings and precautions for use in patients scheduled to undergo coronary angiography. As confirmed with Eli Lilly, the company has already issued a letter to healthcare professionals on the new usage recommendation on 3 & 4 June 2014. The DH will keep vigilant against any safety updates of the products announced by other overseas regulatory authorities.
Ends/ Friday, June 13, 2014
Issued at HKT 14:00
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