Estratest and Estratest HS (esterified estrogens and methyltestosterone) therapy: a summary of safety surveillance data, January 1989 to August 2002.
BACKGROUND
The use of hormone-replacement therapy (HRT) to treat menopausal symptoms has been influenced over the years by various safety concerns. These concerns include endometrial cancer, breast cancer, and cardiovascular disease, and have altered how HRT is prescribed. Evaluating postmarketing surveillance data for a product can help pharmaceutical manufactures and health care providers detect early safety signals that may call for further investigation of the product for safety risks.


OBJECTIVE
This review summarizes the safety surveillance data for Estratest and Estratest HS from January 1989 to August 2002.


METHODS
All adverse-event (AE) data reported to Solvay Pharmaceuticals, Inc., on this brand from January 1989 to August 2002 were accessed from a database system that uses a comprehensive software package for reporting and tracking clinical and postmarketing AEs.


RESULTS
Exposure to the Estratest brand during the 13-year assessment period is estimated at >3.0 million patient-years. A total of 1372 unique case reports containing 2556 AEs were found. Assessment of the 43 (3.1%) serious AE cases reported did not generate any signals that might raise concern on the part of the medical community or consumers. Nonserious events comprising >4% of total AEs were all labeled events and included alopecia (8.8%), acne (5.6%), and hirsutism (4.5%).


CONCLUSIONS
The relatively small number of serious AE reports compared with the significant patient exposure did not generate any signals that might raise concern on the part of the medical community or consumers. The safety profile suggests that continued use at the lowest effective dose is acceptable in menopausal women whose symptoms are not improved by estrogen alone.
Phillips
Eric H
EH
Department of Drug Safety and Surveillance, Solvay Pharmaceuticals, Inc, Marietta, GA30062, USA. eric.phillips@solvay.com
Ryan
Suzanne
S
Ferrari
Rob
R
Green
Clarice
C
D000152:Acne Vulgaris / Q000209:etiology; D016907:Adverse Drug Reaction Reporting Systems; D000505:Alopecia / Q000209:etiology; D002986:Clinical Trials as Topic; D004338:Drug Combinations; D015914:Estrogen Replacement Therapy / Q000009:adverse effects*; D004967:Estrogens / Q000009:adverse effects*; D042724:Estrogens, Esterified (USP); D005260:Female; D006628:Hirsutism / Q000209:etiology; D006801:Humans; D008593:Menopause / Q000187:drug effects*; D008777:Methyltestosterone / Q000009:adverse effects*; D011358:Product Surveillance, Postmarketing; D014481:United States
D004338:Drug Combinations; C084327:Estratest-HS; D004967:Estrogens; D042724:Estrogens, Esterified (USP); D008777:Methyltestosterone