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STRATTERA (atomoxetine) – Association with Increased Blood Pressure and Increased Heart Rate – For the Public

Report a Concern
Starting date:
October 24, 2011
Posting date:
October 24, 2011
Type of communication:
Public Communication
Subcategory:
Drugs
Source of recall:
Health Canada
Audience:
General Public
Identification number:
RA-190001001

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 STRATTERA (atomoxetine)

October 24, 2011

Subject: Association of STRATTERA (atomoxetine) with Increased Blood Pressure and Increased Heart Rate

Eli Lilly Canada Inc. together with Health Canada would like to inform patients and their caregivers of important information about the risk of increased blood pressure and increased heart rate with the use of STRATTERA (atomoxetine). STRATTERA (atomoxetine) is a medicine that is used for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) in children and adults.

Atomoxetine can increase heart rate and blood pressure.  Patients and their caregivers should be aware of the following recommendations:

  • Atomoxetine should not be used in patients with severe heart-related disorders.
  • Atomoxetine should be used with caution in patients whose underlying medical conditions could be worsened by increases in blood pressure or heart rate, such as patients with high blood pressure, a faster than normal heart rate, or other problems relating to the heart or blood vessels to the brain.
  • Patients or their caregivers should tell their doctor if they or their child with ADHD have any heart problems, heart defects, high blood pressure, or a family history of these problems.
  • Patients or their caregivers should call their doctor right away if they or their child with ADHD have any signs of heart problems such as chest pain, irregular heart rate, palpitations, shortness of breath, dizziness, or fainting while taking atomoxetine.

Patients should not stop treatment with atomoxetine or modify the dosage, without discussing their condition with their healthcare professional. In addition to this advisory, a letter is being issued to health care professionals concerning this information. A copy of the letter can be accessed at the Healthy Canadians website or at Eli Lilly Canada.

The Canadian prescribing information for STRATTERA has recently been revised to include this important safety information.

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-marketing adverse reactions are generally presumed to underestimate the risks associated with health product treatments.  Any case of serious increases in blood pressure or heart rate or other serious or unexpected adverse reactions in patients receiving STRATTERA should be reported to Eli Lilly Canada Inc. or Health Canada.

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

You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following 3 ways:

  • Report online at MedEffect™ Canada
  • Call toll-free at 1-866-234-2345
  • Complete a Reporting Form and:
    • Fax toll-free to 1-866-678-6789, or
    • Mail to: Canada Vigilance Program
      Health Canada
      Postal Locator 0701E
      K1A 0K9

The Reporting Forms, postage paid labels, and Guidelines can be found on the MedEffect™ Canada Web site in the Adverse Reaction and Medical Device Problem Reporting section.

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

Sincerely,

original signed by

Loren D. Grossman, MD, FRCPC, FACP
Vice-President, Research and Development
Eli Lilly Canada Inc.