To print: Select File and then Print from your browser's menu --------------------------------------------------------------------------------------- Title: FDA Approves Yasmin (Drospirenone/Ethinyl Estradiol), Oral Contraceptive Containing Drospirenone URL: http://www.pslgroup.com/dg/1FAFA2.htm Doctor's Guide May 14, 2001
MONTVILLE, NJ -- May 14, 2001 -- Berlex Laboratories, Inc., a U.S. affiliate of Schering AG, Germany, announced today that the U.S. Food and Drug Administration (FDA) approved Yasmin® (drospirenone and ethinyl estradiol), a new, low-dose, monophasic oral contraceptive and the first and only birth control pill to contain the unique progestin, drospirenone. Drospirenone is different from the progestins currently available in other oral contraceptives. As an analogue of spironolactone, which is widely used by Ob/Gyns for many women, drospirenone exhibits antimineralocorticoid activity which influences the regulation of water and electrolyte balance in the body. This activity may increase potassium levels in some patients. Therefore, it is recommended that women with kidney, liver or adrenal disease should not take Yasmin, because this activity could cause serious heart and health problems. Patients taking drugs that could increase potassium should consult their health care professional before taking Yasmin. "Yasmin is the second major innovation that we've introduced to the U.S. market this year. Its market entry, along with the introduction of the levonorgestrel-releasing intrauterine system MIRENA early this year, represents further expansion of the Berlex leadership in contraception," said Reinhard Franzen, Vice President and General Manager, Female Healthcare, Berlex Laboratories, Inc. "Because of the unique clinical pharmacology of Yasmin, we believe this product will provide women with an important new option in contraception." While more than 18 million women in this country use one of the more than 40 oral contraceptives available today, a new national survey of U.S. women aged 18-45 commissioned by the National Women's Health Resource Center (NWHRC) shows that nearly half (47 percent) of women who have used birth control pills in the past five years were dissatisfied enough to discontinue use or switch brands. "Nearly 700,000 unintended pregnancies occur each year in this country because women stop taking their birth control pills," said Amy R. Niles, executive director of the NWHRC. "The results of our survey show that women are dissatisfied with the choices currently available to them. That being the case, an oral contraceptive that makes birth control more acceptable for more women in this country is not only important, but necessary progress." Large-scale clinical trials involving 2,629 women with over 33,160 cycles established the contraceptive effectiveness, safety and menstrual cycle control of Yasmin. Trials found that Yasmin offers excellent cycle control with a low rate of spotting and breakthrough bleeding. Yasmin proved more than 99 percent effective in preventing pregnancy, with only one pregnancy occurring in 3,201 cycles of 326 Yasmin users. Women who participated in clinical studies tolerated Yasmin very well, with only six percent discontinuing use due to side effects. The most common reasons women gave for discontinuing use were emotional liability, headache, nausea, dysmenorrhea, intermenstrual bleeding and depression.
SOURCE: Berlex Laboratories, Inc.
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