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

Starting date:

January 17, 2014

Posting date:

January 17, 2014

Type of communication:

Public Communication

Subcategory:

Drugs

Source of recall:

Health Canada

Issue:

Important Safety Information

Audience:

General Public

Identification number:

RA-37615

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

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

January 17, 2014

Subject: Association of EFFIENT^® (prasugrel hydrochloride) with increased risk of bleeding in patients treated for certain types of heart attacks at the hospital.

Eli Lilly Canada Inc. in collaboration with Health Canada would like to inform patients and their caregivers of important safety information about EFFIENT^® (prasugrel hydrochloride). EFFIENT^® is an antiplatelet medication which lowers the ability of blood to clot.  A doctor can start EFFIENT^® at the hospital around the time of a procedure to open a blocked heart artery in patients with certain types of heart attacks.

• Patients treated for certain types of heart attacks at the hospital are at an increased risk of bleeding when EFFIENT^® is started before looking at the heart arteries with an angiogram (compared to when EFFIENT^® was given after looking at the heart arteries).
• Doctors have been advised to consider this risk when starting treatment with EFFIENT^® for certain types of heart attacks.
• There is no additional harm to people who are already taking EFFIENT^®. Do not stop taking EFFIENT^® without discussing with your doctor. Stopping EFFIENT^® may increase the chance of having a heart attack.

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

Managing marketed health product-related side effects depends on health care professionals and consumers reporting them. Any case of serious or unexpected side effects 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

You can report any suspected side effect 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.