TERAZOL 7 Vaginal Cream 0.4% (terconazole); TERAZOL 3 Dual-Pak - Vaginal Cream 0.8%/Vaginal Ovules 80 mg (terconazole) - Risk of Anaphylaxis and Toxic Epidermal Necrolysis - For the Public
- Starting date:
- June 9, 2014
- Posting date:
- June 9, 2014
- Type of communication:
- Public Communication
- Source of recall:
- Health Canada
- Important Safety Information
- General Public
- Identification number:
This is duplicated text of a letter from Janssen Inc. Contact the company for a copy of any references, attachments or enclosures.
PUBLIC COMMUNICATION - Health Canada Endorsed Important Safety Information on TERAZOL 7 (terconazole) Vaginal Cream and TERAZOL 3 Dual-Pak (terconazole) Vaginal Cream/Vaginal Ovules
June 9, 2014
Subject: New safety information regarding the risk of anaphylaxis and Toxic Epidermal Necrolysis (TEN) associated with TERAZOL® 7 Vaginal Cream 0.4% (terconazole); TERAZOL® 3 Dual-Pak®- Vaginal Cream 0.8%/Vaginal Ovules 80 mg (terconazole)
Janssen Inc., in consultation with Health Canada, would like to inform you about important new safety information regarding the risk of serious allergic reactions associated with the use of TERAZOL®.
TERAZOL® 7 Vaginal Cream and TERAZOL® 3 Dual-Pak® Vaginal Cream/Vaginal Ovules are used for the treatment of yeast infections caused by an organism called Candida albicans.
- Very rare cases of serious or even life-threatening allergic reactions including anaphylaxis and Toxic Epidermal Necrolysis (TEN) have been reported in patients taking TERAZOL®.
Signs and symptoms of serious allergic reactions may include:
- Anaphylaxis: swollen face, lips, mouth, tongue or throat, and difficulty swallowing or breathing.
- TEN: flu-like symptoms, fever, itching of the skin, mouth sores, tender or painful skin rash that spreads and blisters causing the skin to shed over much of the body.
- If you experience any of the symptoms mentioned above while taking TERAZOL®, stop the treatment and call your doctor or pharmacist immediately.
Janssen Inc. has provided this information to doctors and pharmacists across Canada. Information regarding the risk of serious allergic reactions has been included in the consumer information document. For more information, patients should consult their healthcare professional.
Managing marketed health product-related side effects depends on healthcare professionals and consumers reporting them. Any case of anaphylaxis, TEN, or other serious or unexpected adverse reactions in patients receiving TERAZOL® 7 or TERAZOL® 3 Dual-Pak® should be reported to Janssen Inc. or Health Canada.
Drug Safety Department
19 Green Belt Drive
Or call toll free at 1-866-825-7122
Or email to firstname.lastname@example.org
Or fax to 1-866-767-5865
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
original signed by
Cathy Lau, Ph.D.
Regulatory Affairs and Quality Management
For more informationThrough surveillance, the manufacturer identified a risk associated with the product and has submitted to Health Canada an update to its product label to reflect the findings. The label changes have been reviewed and approved by Health Canada. A comprehensive internal signal assessment was not required for this issue, and therefore a Summary Safety Review is not available.
- Date modified: