EFFIENT (prasugrel hydrochloride) - Association with Increased Risk of Bleeding in Patients Treated in Hospital for Certain Types of Heart Attacks - For Health Professionals

Starting date:

January 17, 2014

Posting date:

January 17, 2014

Type of communication:

Dear Healthcare Professional Letter

Subcategory:

Drugs

Source of recall:

Health Canada

Issue:

Important Safety Information

Audience:

Healthcare Professionals

Identification number:

RA-37611

This is duplicated text of a letter from Eli Lilly Canada Inc. Contact the company for a copy of any references, attachments or enclosures.

Notice about Health Canada advisories

Health Canada Endorsed Important Safety Information on EFFIENT (prasugrel hydrochloride)

January 17, 2014

Dear Healthcare Professional:

Subject: Association of EFFIENT^® (prasugrel hydrochloride) with increased risk of serious bleeding in UA/NSTEMI patients undergoing percutaneous coronary intervention (PCI) when administered prior to diagnostic angiography.

Eli Lilly Canada Inc. in collaboration with Health Canada would like to inform you of important safety information about EFFIENT^® (prasugrel hydrochloride), an antiplatelet agent indicated for the prevention of atherothrombotic events in patients with acute coronary syndromes.

This communication 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.

In a clinical trial involving NSTEMI patients (the ACCOAST study), EFFIENT^® loading dose (30 mg) given 2 to 48 hours (average 4 hours) prior to diagnostic coronary angiography followed by 30 mg at the time of PCI increased the risk of major and minor peri-procedural bleeding compared with prasugrel loading dose (60 mg) at the time of PCI. No differences in either efficacy or fatal bleeding were observed between the two dosing regimens.

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.

This communication is posted on the Healthy Canadians Web site and on the Eli Lilly Canada Inc. Web site.

The Canadian Product Monograph for EFFIENT^® has recently been revised to include this new safety finding.  A copy of the most up-to-date Product Monograph can be found on the Health Canada Web site and on the Eli Lilly Canada Inc. Web site.

Managing marketed health product-related adverse reactions depends on health care professionals and consumers reporting them. Reporting rates determined on the basis of spontaneously reported post-market adverse reactions are generally presumed to underestimate the risks associated with health product treatments. Any cases of serious or unexpected adverse reactions in patients receiving EFFIENT^® should be reported to Eli Lilly Canada Inc. or Health Canada.

Eli Lilly Canada Inc.
Toronto, Ontario
1-888-545-5972

To correct your mailing address or fax number, contact Eli Lilly Canada Inc.

You can report any suspected adverse reactions associated with the use of health products to Health Canada by:

• Calling toll-free at 1-866-234-2345; or
• Visiting MedEffect Canada's Web page on Adverse Reaction Reporting for information on how to report online, by mail or by fax.

For other health product inquiries related to this communication, please contact Health Canada at:
Marketed Health Products Directorate
E-mail: mhpd_dpsc.public@hc-sc.gc.ca
Telephone: 613-954-6522
Fax: 613-952-7738

Sincerely,

original signed by

Doron Sagman, MD, FRCPC
Vice President, Research & Development
Eli Lilly Canada Inc.

Reference:

1 Montalescot G, Bolognese L, Dudek D, et al.  Pretreatment with Prasugrel in Non-ST-Segment Elevation Acute Coronary Syndromes.  N Engl J Med. 2013;369:999-1010