Archived - Drug Release Information for the EVRA Transdermal Contraceptive System - For the Public

Starting date:

March 19, 2009

Posting date:

March 19, 2009

Type of communication:

Public Communication

Subcategory:

Drugs

Source of recall:

Health Canada

Audience:

General Public

Identification number:

RA-19000741

This is duplicated text of a letter from Janssen-Ortho 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 About EVRA Transdermal Contraceptive System

March 19, 2009

Subject: Information Provided About EVRA ^{Footnote *} Birth Control Patch Average Daily Release Rate

Janssen-Ortho Inc., in cooperation with Health Canada, is providing the public with new information on the average daily release rates of contraceptive hormones from the EVRA Transdermal Contraceptive System (patch). The EVRA patch marketed in Canada contains 6.0 milligrams (mg) of norelgestromin and 0.60 mg of ethinyl estradiol and is approved for use in contraception (prevention of pregnancy). 

Consumers should be aware of the following information:

• The EVRA product monograph now includes new information on the average daily release rates of the contraceptive hormones norelgestromin (200 micrograms [µg] every 24 hours) and ethinyl estradiol (35 µg every 24 hours). This information replaces the previously labelled daily delivery rate of norelgestromin (150 μg every 24 hours) and ethinyl estradiol (20 μg every 24 hours).
• The new information on the average daily release rate was determined by measuring hormone content that remained in the EVRA patches worn by women for 7 days. The previously labelled delivery rate information was estimated using a different method. The term "release rate" has replaced the previously labelled term "delivery rate" as a more descriptive term regarding release of hormones from the patch.
• There has been no change to the way the EVRA patch is made. The estimates of actual exposure to the hormones from the EVRA patch (amount of contraceptive hormones actually measured in the blood stream) have not changed. There is no known impact on the safety and effectiveness of the EVRA patch as a result of the new information on the average daily release rate.

Previous Public Advisories
Health Canada issued three previous Public Advisories pertaining to EVRA on November 28, 2005, March 30, 2006 and November 21, 2006. These can be found on the Health Canada web site. The present health professional communication is the result of a follow-up commitment by Janssen-Ortho Inc. in November 2006 to provide information regarding an additional study to re-evaluate the average daily amount of hormones released from the EVRA Transdermal Contraceptive System.

This information is also available on the Janssen-Ortho web site. For more information, patients should consult their health care professional. Patients should NOT discontinue their medication without consulting their physician or pharmacist first. If you have questions about EVRA, please talk to your doctor or take the medication back to your pharmacy and speak to your pharmacist.

Janssen-Ortho Inc. is a research-based pharmaceutical company located in Toronto, Canada.

The identification, characterization, and management of marketed health product-related adverse reactions are dependent on the active participation of health care professionals in adverse drug reaction reporting programs. Any occurrences of serious and/or unexpected adverse reactions in patients receiving EVRA should be reported to Janssen-Ortho Inc. or the Marketed Health Products Directorate at the following addresses:

Janssen-Ortho Inc.
19 Green Belt Drive
Toronto, Ontario
M3C 1L9
Or call toll-free at 1-800-567-3331
Or email to dsscan@joica.jnj.com
Or toll-free fax to 1-866-767-5865

Any suspected adverse reaction can also be reported to:
Canada Vigilance Program
Marketed Health Products Directorate
HEALTH CANADA
Address Locator: 0701C
Ottawa, Ontario, K1A 0K9
Telephone: 613-957-0337 or Fax: 613-957-0335
To report an Adverse Reaction, consumers and health professionals may call toll free:
Telephone: 1-866-234-2345
Fax: 1-866-678-6789
CanadaVigilance@hc-sc.gc.ca

The Adverse Reaction Reporting Form and the Adverse Reaction Guidelines can be found on the Health Canada Web site or in The Canadian Compendium of Pharmaceuticals and Specialties.

For other inquiries related to this communication, please contact Health Canada at:
Therapeutic Products Directorate (TPD)
Bureau of Metabolism, Oncology and Reproductive Sciences (BMORS)
E-mail: bmors_enquiries@hc-sc.gc.ca
Telephone: 613-941-3171
Fax: 613-941-1365

For further information on Janssen-Ortho Inc.: call Suzanne Frost, Janssen-Ortho Inc., (416) 449-9444. Should you have any questions or require additional information regarding the use of EVRA, please contact Janssen-Ortho Inc. Medical Information Department at 1-800-567-3331 from 8:30 am to 4:30 pm Monday to Friday Eastern Standard Time (EST) or by facsimile at 416-449-2658. A copy of this communication is also available on the Janssen-Ortho web site.

Sincerely,

original signed by

Cathy Lau, Ph.D.
Vice-President
Regulatory and Quality