yasmin

The specter of increased venous thromboembolism risk may be rising once again above a corner of Europe's oral contraceptive market, conjured this time by Dutch physicians and their concerns about the oral contraceptive Yasmin. But Schering AG, which manufactures Yasmin, insisted that worldwide data demonstrate that Yasmin users face no greater risk of venous thromboembolism (VTE) than do women using other oral contraceptives, according to post-marketing surveillance data. In addition, the Netherlands' drug regulatory administration concluded in a statement that available data show Yasmin is as safe as other oral contraceptives. In the United States, the Food and Drug Administration, which approved Yasmin last year, hasn't issued any new advisories about Yasmin and VTE risks. Yasmin is a low-dose, monophasic oral contraceptive. Unlike third-generation oral contraceptives containing the progestins desogestrel or gestodene, Yasmin combines 0.03 mg of ethinyl estradiol with 3 mg of the progestin drospirenone, an analogue of the diuretic spironolactone. About 1 million women worldwide are using Yasmin, according to a spokesperson for Schering's U.S. subsidiary, Berlex Laboratories Inc., Montville, N.J. Two cases of VTE in Dutch women using Yasmin, one of which was fatal, prompted the Dutch government's drug regulatory body, the Medicines Evaluation Board, to take a closer look. The board uncovered about 40 reported cases of VTE among European women taking Yasmin; two of these cases, including one fatality, were in Dutch women. The board concluded in a statement released in March that Yasmin is neither safer nor less safe than other oral contraceptives, based on available data. A "considerable" number of the VTE cases among Yasmin users involved known thrombosis risk factors associated with OC use, including smoking and being overweight, the report said. The board did require Schering to add a sentence to Yasmin's labeling emphasizing that the VTE risk associated with Yasmin use, compared with that of other OCs, is still unknown. To clear up the uncertainty, the board also asked Schering to conduct a 3-year study comparing adverse reactions among 3,000 women using either Yasmin or second-generation OCs. In April, the Dutch College of General Practitioners cautioned clinicians to continue making prescriptions for second-generation oral contraceptives their first choice until they see more evidence that the VTE risk associated with Yasmin use doesn't exceed that of earlier OCs. According to a spokeswoman for Berlex, data from more than 700,000 women-years of use do not indicate that Yasmin is linked with a greater VTE risk than other oral contraceptives. According to a postmarketing surveillance study of 18,000 women, the incidence of VTE among Yasmin users has been lower than that among women taking second- or third-generation oral contraceptives. Among the 30% of the study population using Yasmin, only one case of VTE has occurred; researchers have reported five cases among study participants using other contraceptives.

Yasmin (Drosperinone/Ethinyl Estradiol) Found to Relieve Pre-Menstrual SymptomsPHILADELPHIA, PA -- August 22, 2001 -- Researchers report that a combination of components found in the oral contraceptive Yasmin® (drosperinone/ethinyl estradiol) have been found to ease the symptoms of premenstrual syndrome (PMS) and premenstrual dysphoric disorder (PMDD), a severe form of PMS distinguished by significant irritability or depression and other mood problems. According to Ellen Freeman, PhD, of the department of Obstetrics and Gynecology in the University of Pennsylvania School of Medicine and lead author of the study, the oral contraceptive may offset the major symptoms of PMS and PMDD by suppressing ovulation, reducing water retention, and counteracting the effects of testosterone. The results of the double-blind, multi-site study are published in the current issue of the Journal of Women's Health and Gender-Based Medicine. "The majority of women experience some physical and emotional changes as part of their menstrual cycle, but for some - especially those diagnosed with PMDD - it can be disabling," said Dr. Freeman, research professor and co-director of Penn's Division of Human Behavior and Reproduction. "The advantage of using an oral contraceptive to treat PMDD is that it provides contraception and a possible reduction of menstrually-related symptoms." Yasmin contains a combination of estrogen and a unique progestin, drospirenone. Drospirenone, is chemically similar to spironolactone, a diuretic that doctors prescribe to treat water retention. Additionally, studies have suggested that drospirenone may also be effective in calming symptoms such as premenstrual irritability that may be associated with high testosterone levels. "This is the first report of the use of an oral contraceptive that treats multiple symptoms of PMDD," said Dr. Freeman. "Our results suggest that Yasmin has promise as a treatment for both the mood and physical symptoms of premenstrual syndromes." Dr. Freeman and colleagues from a number of sites across the U.S. enlisted 82 women, aged 18-40, to take part in the study to evaluate the efficacy of Yasmin in the treatment of PMDD. Qualified volunteers with PMDD were randomized and treated with either Yasmin or a placebo. Neither the patients nor the clinicians knew which treatment was administered. The volunteers recorded their PMDD symptoms using the Calendar of Premenstrual Experiences (COPE), a tool standardized for use in PMS/PMDD studies. Each day of the three-month study, the participants reported the severity of their symptoms on the COPE scale, via a call to an automated telephone system. Overall, the Yasmin users showed greater reduction in the severity of symptoms than the placebo group for all symptoms rated on the COPE scale. The researchers noted statistically significant improvement with the contraceptive in symptoms such as acne, increased appetite and food cravings. In addition, Yasmin was well tolerated, and reports of adverse events were typical of those associated with oral contraceptive use. Since diuretic medications may increase the potassium level in some people, women should consult their physicians before taking Yasmin. Women who have kidney, liver or adrenal disease should not take the contraceptive, because this activity could cause serious health problems. Contributors to this research include Robin Kroll, MD, of the North Seattle Women's Group in Seattle, Washington and Andrea Rapkin, MD, of the University of California, Los Angeles. This study was funded by Berlex Laboratories, Inc., the makers of Yasmin. The researchers agree that this study is a first step in determining if Yasmin is an effective treatment for PMDD, and recommend further studies to refute or confirm these promising results. "Women should realize that they do not have to have their lives disrupted by the effects of PMS and PMDD," said Dr. Freeman. "What we have to remember is that the feelings of bloating, pain, and frustration are physical and emotional manifestations of a real cyclical disorder - one that can be treated." SOURCE: University of Pennsylvania Medical Center

YAZ® approved in the Netherlands as European Reference Member StateBayer Schering Pharma AG, Germany, announced today that the Dutch regulatory authorities have granted national approval for their new low dose 24-day oral contraceptive YAZ® (3 mg drospirenone/20 mcg ethinyl estradiol) in the Netherlands. YAZ® will be registered for the indications oral contraception and the treatment of moderate acne in women seeking contraception. The Netherlands will serve as the Reference Member State for the upcoming Mutual Recognition Procedure to gain European-wide marketing approval for the product. "We are very excited about this first European approval for YAZ®. YAZ® is the first oral contraceptive to combine the unique progestin drospirenone with 20 mcg of ethinyl estradiol in a 24-day active hormone pill regimen. Through its innovative active ingredient drospirenone, YAZ® offers additional benefits, such as the treatment of acne, to women who want reliable birth control," said Phil Smits, M.D., Head of Women's Healthcare at Bayer Schering Pharma AG.YAZ®, which has been available in the U.S. since April 2006, is the fastest-growing oral contraceptive brand in the U.S. YAZ® is also the only oral contraceptive with clinically proven efficacy in the treatment of the emotional and physical symptoms associated with PMDD (Premenstrual Dysphoric Disorder), such as mood swings, irritability, anxiety, changes in appetite and eating habits, breast tenderness, bloating, and headache. YAZ® was granted this indication in the USA in October 2006. Bayer Schering Pharma AG plans to proceed with the application for the registration of the PMDD indication in Europe. With the approval for the treatment of acne in January 2007, YAZ® becomes the first and only oral contraceptive ever approved in the USA for three distinct indications.