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| |  Data Supports Safety Of Estratest For Menopause ATLANTA, GA -- March 9, 1998 -- A data analysis published in a recent issue of Clinical Therapeutics supports the overall safety of the most commonly prescribed oral estrogen/androgen therapy, Solvay Pharmaceuticals Inc.’s Estratest(R) (esterified estrogens and methyltestosterone) Tablets. The drug is indicated for the treatment of vasomotor symptoms (such as hot flashes) in patients who do not respond to estrogens alone. Since 1989, more than 368 million Estratest Tablets have been prescribed in the United States. The analysis demonstrates a low volume of adverse events reported between 1989-1996 given the exposure to therapy. During this seven-year surveillance period, 568 women reported a total of 863 adverse events (as some patients experienced more than one). According to the report, no deaths were reported and no significant adverse events occurred to indicate the need for more intensive surveillance. The most commonly reported adverse events were those typical of estrogen therapy (such as weight gain, headache, nausea and vasodilatation) and of androgen treatment (including alopecia, acne and hirsutism). The safety analysis encompassed adverse events spontaneously reported from 1989 to 1996 which were entered into ARIS. The sources of adverse event reports included: consumers, healthcare professionals, clinical studies and the U.S. Food and Drug Administration (FDA). "These safety findings emphasise that there is another safe and acceptable hormonal option available to that of estrogen alone. For many women, a one-size-fits-all estrogen therapy may not be enough to manage all of their menopausal symptoms," said Gloria Bachmann, MD, professor and departmental chief of general obstetrics and gynecology for the University of Medicine and Dentistry of New Jersey. "Instead of increasing a patient's dosage of estrogen, physicians might consider customising treatment with estrogen/androgen therapy for relief of persistent vasomotor symptoms." "Androgens are one of the hormones a woman's body makes. Androgen levels decrease dramatically (up to 50 percent) during menopause. Clearly, this safety surveillance evidence offers physicians a reason to re-evaluate their approach to menopause management to include combination estrogen/androgen therapy for the appropriate patients," said Philip Sarrel, MD, professor of obstetrics and psychiatry, Yale University School of Medicine. When making the decision whether to use hormone replacement therapy, women should talk with a healthcare professional and provide him/her with a complete personal and family health history, including past cases of cancer of the breast or uterus, unusual vaginal bleeding, abnormal blood clotting or heart disease. Estratest and Estratest H.S. (Half Strength) Tablets are the most prescribed estrogen/androgen treatment available for women. Estratest Tablets provides a natural combination of estrogen and androgen indicated for the management of moderate to severe vasomotor symptoms associated with menopause in patients who do not respond to estrogens alone.
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