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Propecia Now Available In U.S.January 21, 1998Propecia(R) (finasteride 1 mg), the first and only pill to treat male pattern hair loss (androgenetic alopecia), for use in men only, is now available on American pharmacy shelves nationwide, Merck & Co., Inc. announced today. Propecia was given marketing clearance by the U.S. Food and Drug Administration on Dec. 19, 1997. Hair naturally grows at a rate of about 1/2 inch per month, so it may take three to six months for the effect of Propecia to be visible. Therefore, to encourage men to stay on therapy for the long-term, Propecia is available in special ProPak(TM) convenience packages as well as in bottles of 30. The ProPak features a three-month supply, a $10 patient rebate and an informational patient brochure. The FDA's marketing clearance of Propecia was based on clinical studies in over 1,800 men for up to two years. In clinical studies, hair count increased during the first year and was maintained in those men taking Propecia for 24 months; men in the placebo group continued to show progressive hair loss. In an analysis of 1,215 men with hair loss in the vertex area of the scalp who were followed for up to two years, only 17 percent of men treated with Propecia demonstrated hair loss (defined as any decrease in hair count from baseline); 83 percent had the same or higher hair count. In contrast, 72 percent of the placebo group lost hair, as measured by hair count. In another analysis, a panel of independent dermatologists studied photos of 508 patients after two years of treatment. A visible increase in vertex hair was seen in 66 percent of men, compared with 7 percent of men treated with placebo. Comparable results were also demonstrated in the anterior mid-scalp area. Propecia was generally well tolerated and side effects were uncommon. A small number of men reported less desire for sex, difficulty in achieving an erection and/or a decrease in the amount of semen. Each of these side effects occurred in less than two percent of men. These side effects went away in all men who discontinued therapy because of them and also disappeared in 58 percent of men who chose to continue taking Propecia. Propecia is for use by men only and should not be used by women or children. Women must not use Propecia when they are or may potentially be pregnant because it may cause abnormalities of the male baby's sex organs, a condition known as hypospadias. In addition, women should not handle crushed or broken tablets when they are pregnant or may potentially be pregnant. Propecia tablets have a coating that will prevent contact with the active ingredient during normal handling, provided that the tablets have not been broken or crushed. WEST POINT, PA |
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