NUVARING (etonogestrel / ethinyl estradiol slow release vaginal ring) - New Usage Restrictions - For the Public
- Starting date:
- July 30, 2014
- Posting date:
- July 31, 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 Merck Canada Inc. Contact the company for a copy of any references, attachments or enclosures.
PUBLIC COMMUNICATION - Health Canada Endorsed Important Safety Information on NUVARING
July 30, 2014
Subject: New usage restrictions for NUVARING® (etonogestrel / ethinyl estradiol slow release vaginal ring)
Merck Canada Inc., in consultation with Health Canada, would like to inform you of new usage restrictions for NUVARING®.
NUVARING® is prescribed for birth control.
- NUVARING® should NOT be used by women who smoke and are over the age of 35, or who have more than one or a serious form of the following: heart problems, high blood pressure, blood tests indicating abnormal levels of fats or substances that control blood clotting, diabetes, or limited ability to move around for a long time after an operation.
- NUVARING® should NOT be used by women who have experienced migraine headaches with vision problems, or constant stomach pain caused by problems in the pancreas along with high levels of fats in the blood.
- Speak with your doctor if you have any concerns about the use of NUVARING®.
In addition to the above usage restrictions, you should be aware of the following possible problems: joint pain and swelling, uncoordinated jerking movements, skin blistering, hearing loss, liver cancer, gut problems, and swelling around the eyes, face and lips. Talk to your doctor right away if you experience any of these problems.
Merck Canada Inc., in working with Health Canada, has updated the safety information for NUVARING® regarding the above new usage restrictions and warnings which are also associated with other similar birth control products.
Merck Canada Inc. has sent a letter to health care professionals informing them of the above new safety information. This information may also be obtained on the web sites of Health Canada and Merck Canada Inc. If you have questions regarding your NUVARING® prescription, please contact your doctor.
Managing marketed health product-related side effects depends on health care professionals and consumers reporting them. Any case of serious or unexpected adverse reactions in patients receiving NUVARING® should be reported to Merck Canada Inc. or Health Canada.
Merck Canada Inc.
Medical Information Centre
16750 Trans-Canada Hwy.
Kirkland, Québec H9H 4M7
Tel: 514-428-8600 or 1-800-567-2594
Fax: 514-428-8675 or 1-877-428-8675
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
If you have any questions regarding this important information or for any medical or health-related inquiries, your healthcare professional (physician, pharmacist, nurse, etc.) is the most qualified person to respond since the answer to your questions may vary based on your health condition.
original signed by
Mauricio Ede, M.D.
Executive Director, Medical Affairs
® Registered trademark of Merck Sharp & Dohme B.V. Used under license.
1 NUVARING® (etonogestrel / ethinyl estradiol slow release vaginal ring) Product Monograph, May 12, 2014