Archived – Important Safety Information Regarding Estrogen Plus Progestin Tablets (PremplusTM) – For the Public

Starting date:

July 16, 2003

Posting date:

July 29, 2003

Type of communication:

Public Communication

Subcategory:

Drugs

Source of recall:

Health Canada

Issue:

Important Safety Information

Audience:

General Public

Identification number:

RA-1900090

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

Notice about Health Canada advisories

July 16, 2003

Public Advisory

Dear Patients:

SUBJECT: Important drug safety information for women 65 years of age or older being treated with estrogen plus progestin (Premplus^TM)

Wyeth Canada is advising patients over 65 of new safety information concerning estrogen and progestin hormone replacement therapy.

In consultation with Health Canada, Wyeth Canada has recently informed all Canadian physicians and pharmacists of the findings of the Women's Health Initiative Memory Study (WHIMS). WHIMS is a clinical study looking at changes in memory and mental abilities of women 65 years of age or older.

In May 2003, the authors of WHIMS publications reported that women over 65 who were taking combination estrogen plus progestin therapy, had a higher chance of developing symptoms of probable dementia, compared with women from the control group (i.e., women not taking any hormones). This observation was noted in the second year of the study and persisted throughout the study. The risk of possible dementia was highest in the oldest age group studied (women 75 and older). Dementia is a deterioration of intellectual function and other cognitive skills leading to a declined ability to perform activities of daily living.

In a separate report on WHIMS, the effect of hormone therapy on cognitive function (mental abilities) was also evaluated. Overall, there was no clinically significant difference between the group of women on combination estrogen plus progestin therapy and those not taking any hormones. The average cognitive test score for these women improved in both groups. However, the treated group improved somewhat less than the group that did not take any hormones. Additionally, more women in the estrogen plus progestin group had an important decline in cognitive function compared to the control group.

Health Canada and Wyeth Canada recognize the potential relevance of this information to women aged 65 and older. WHIMS evaluated women who were on average 71 years of age, and, therefore, the extrapolation of these results to younger women is not established. The results from WHIMS should be carefully interpreted in the assessment of risk and benefit for women who are taking or considering initiating estrogen plus progestin therapy. The final recommendation requires a case-by-case approach.

Premplus^TM is approved in Canada for the relief of menopausal symptoms such as hot flashes, night sweats, and vaginal dryness, and for the prevention of postmenopausal osteoporosis. Hormone therapy should be prescribed at the lowest dose for the shortest duration consistent with individual treatment goals and risks for the individual woman.

In addition to advising patients of this safety information, Wyeth Canada is working with Health Canada to ensure that the information is included in a revised Product Monograph for Premplus^TM.

For further information, please contact:

Wyeth Canada
Medical Information and Pharmacovigilance
Tel.: 1-800-461-8844.

Any suspected adverse reactions can also be reported to:

Canadian Adverse Drug Reaction Monitoring Program (CADRMP)
Marketed Health Products Directorate
HEALTH CANADA
Address Locator: 0201C2
OTTAWA, Ontario, K1A 1B9
Tel: (613) 957-0337 or Fax: (613) 957-0335
Toll free for consumers and health professionals:
Tel: 866 234-2345, Fax: 866 678-6789
cadrmp@hc-sc.gc.ca

The AR Reporting Form and the AR Guidelines can be found on the TPD web site or in The Canadian Compendium of Pharmaceuticals and Specialties.