National survey demonstrates need for new birth control pill options
Montville, NJ, May 14, 2001 -- Berlex Laboratories, Inc., a U.S. affiliate of Schering AG, Germany (NYSE:SHR), announced today that the U.S. Food and Drug Administration (FDA) approved YASMIN (R) (drospirenone and ethinyl estradiol). YASMIN is a new, low-dose, monophasic oral contraceptive and the first and only birth control pill to contain the unique progestin, drospirenone.
YASMIN is the second major innovation that weve 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.
Drospirenone is different from the progestins currently available in other oral contraceptives. As an analogue of spironolactone, widely used by Ob/Gyns for many women, drospirenone exhibits antimineralocorticoid activity that 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.
The launch of YASMIN continues in the tradition of Berlexs parent company, Schering AG, which introduced oral contraceptives in the European market 40 years ago. Over 500,000 women in Europe are currently using YASMIN, where the product has been available in several countries, including Germany, since November of 2000.