NUVARING (etonogestrel / ethinyl estradiol slow release vaginal ring) - New Usage Restrictions - For Health Professionals

Starting date:

July 30, 2014

Posting date:

July 31, 2014

Type of communication:

Dear Healthcare Professional Letter

Subcategory:

Drugs

Source of recall:

Health Canada

Issue:

Important Safety Information

Audience:

Healthcare Professionals

Identification number:

RA-40839

This is duplicated text of a letter from Merck Canada Inc. Contact the company for a copy of any references, attachments or enclosures.

Notice about Health Canada advisories

Health Canada Endorsed Important Safety Information on NUVARING

July 30, 2014

Dear Health Care Professional,

Subject:     New Contraindications regarding NUVARING^® (etonogestrel / ethinyl estradiol slow release vaginal ring)

Merck Canada Inc., in consultation with Health Canada, would like to inform you of new Contraindications that have been added to the NUVARING^® Product Monograph (PM).

NUVARING^® is a combined hormonal contraceptive (CHC) indicated for conception control.

The following points summarize the important changes that have been made to the PM:

• NUVARING^® should NOT be used by women who smoke (if over age 35), or who have severe or multiple risk factors for thrombosis, including: valvular heart disease with complications, hypertension, severe dyslipoproteinemia, abnormality in proteins that regulate coagulation, diabetes mellitus with vascular involvement, or major surgery with prolonged immobilization.
• NUVARING^® should NOT be used by women who have experienced migraines with focal neurological symptoms, or pancreatitis associated with severe hypertriglyceridemia.
• Prescribers should consider the above new contraindications and review the updated PM when discussing treatment options with their patients. 

In addition to the above contraindications, changes have also been made under WARNINGS AND PRECAUTIONS section of the PM regarding the following possible adverse events: systemic lupus erythematosus, sydenham’s chorea, herpes gestationis, otosclerosis-related hearing loss, hepatocellular carcinoma, Crohn’s disease, colitis ulcerosa and angioedema.

Merck Canada Inc., in working with Health Canada, has updated the NUVARING^® PM regarding the above new contraindications and warnings which are also associated with other CHC products.

For more details, Merck Canada Inc. encourages you to review the updated NUVARING^® PM¹, which can be found on the websites of Health Canada and Merck Canada Inc.

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 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
Email: medinfocanada@merck.com

To correct your mailing address or fax number, contact Merck Canada Inc.

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
E-mail: mhpd_dpsc.public@hc-sc.gc.ca
Telephone: 613-954-6522
Fax: 613-952-7738

If you have any questions regarding this important information or for any medical inquiries on Merck Canada products, please call the Merck Canada Medical Information Centre using the contact information mentioned above.

Sincerely,

original signed by

Mauricio Ede, M.D.
Executive Director, Medical Affairs

^® Registered trademark of Merck Sharp & Dohme B.V. Used under license.

References:

1 NUVARING ^® (etonogestrel / ethinyl estradiol slow release vaginal ring) Product Monograph, May 12, 2014