Safety and Efficacy of Combined Oral Contraceptive Ethinyl Estradiol/Drospirenone (YAZ) in Chinese Women: A Single-Arm, Open-Label, Multicenter, Post-Authorization Study.

INTRODUCTION: The study was conducted to assess the safety and efficacy of a combined oral contraceptive, YAZ, containing 3 mg drospirenone/20 µg ethinyl estradiol administered in a 24/4 regimen. METHODS: This was a single-arm, open-label, interventional, post-authorization safety surveillance study of YAZ across 6 treatment cycles. Primary objective was assessing its safety profile in Chinese women. Secondary objectives included assessing contraceptive efficacy, cycle control, and bleeding patterns among subjects with and without preceding abortion, along with efficacy in moderate acne vulgaris. Subgroup analyses included assessing efficacy in the dysmenorrhea group using a visual analog scale. All variables were analyzed by descriptive statistical methods. RESULTS: Of 1921 women treated with YAZ (mean age: 29.9 ± 5.5 years), 12.9% reported adverse drug reactions. Most frequently reported adverse events were nausea (2.6%), breast pain (2.3%), and breast swelling (1.3%). Unintended pregnancy rate (adjusted Pearl Index) was 0.3 (n = 2 pregnancies, 95% confidence interval 0.1-1.2). Incidence of overall withdrawal bleeding (cycle 2-cycle 5) was 93.3%-95.2%, of which 87.8%-95.1% in post-abortion subjects and 94.0%-95.3% in subjects without preceding abortion. Intra-cyclic bleeding (cycle 2-cycle 6) decreased in the overall population (from 14.9 to 5.5%), post-abortion subgroup (32.4% to 6.9%), and in subjects without preceding abortion (12.4% to 5.3%). Incidence of onset of withdrawal bleeding < 7 days among abnormal uterine bleeding patients at baseline was 85.2% and 87.2% at cycles 2 and 5, respectively, and incidence of intra-cyclic bleeding was 23.5% and 8.0% at cycles 1 and 6, respectively. Mean percent change in total acne lesion count from baseline to cycle 6 was - 79.9% ,and mean change in pain severity due to dysmenorrhea was - 31.2 mm at cycle 6 when compared with baseline. CONCLUSION: The 24/4 YAZ regimen showed good safety profile, contraceptive reliability, good cycle control along with subgroup of patients. Improvements in dysmenorrhea and acne were also observed. No events of venous thromboembolism/arterial thromboembolism were reported. TRIAL REGISTRATION: ClinicalTrials.gov identifier, NCT02710708; Center for Drug Evaluation (CDE), China Food and Drug Administration (CFDA) number: CTR20160203.

"One Blood Clot Is One Too Many": Affected Vocal Users' Negative Perspectives on Controversial Oral Contraceptives.

In this article, I analyze women's negative experiences with the fourth generation of contraceptive pills: controversial drugs Yaz and Yasmin. Drawing on in-depth interviews with 24 contraceptive users residing in Canada, I highlight how women who have experienced deleterious side effects understand the risks of hormonal contraception and advocate for changes in health risk communication and prescription drug regulation. Findings show that interviewees did not feel they received adequate risk information prior to starting their new drug regimen nor did they think that pregnancy risks should be used as a comparison point for placing hormonal contraceptive risk into perspective. Patient views were generally underlined by a critique of professional risk/benefit assessment techniques and procedures. To illustrate how the modern complexities of health risk assessment extend to the realm of hormonal contraceptives, I here provide a detailed examination of women's negative experiences while on the pill.

Drospirenone-containing oral contraceptives and venous thromboembolism: an analysis of the FAERS database.

INTRODUCTION: Substantial evidence suggests that drospirenone-containing oral contraceptives may cause a higher risk of venous thrombotic events than earlier-generation oral contraceptives. METHODS: To gain insight into recent real-world implications, we conducted an analysis using the US Food and Drug Administration's Adverse Event Reporting System. RESULTS: Venous thrombotic events continue to be reported at a much higher rate with drospirenone-containing oral contraceptives than the general background. The disproportionality has been rising since 2010. The same behavior is not seen with levonorgestrel-containing oral contraceptives. CONCLUSION: Our results are consistent with decreased physician and patient awareness of risks associated with drospirenone-containing oral contraceptives.

Pregnancy is more dangerous than the pill: A critical analysis of professional responses to the Yaz/Yasmin controversy.

The fourth and most recent generation of hormones used in oral contraceptives has stirred a significant amount of debate regarding the safety of these compounds. Drospirenone, a new type of synthetic hormone used in popular oral contraceptives Yaz and Yasmin, has been found by epidemiologists to increase the risk of blood clots when compared to the previous generations of pills. North American regulatory bodies have investigated the health risks of drospirenone and concluded that the increased risks do not require pulling the new contraceptive technology off the market. Instead, the FDA and Health Canada along with several medical associations have actively managed the Yaz/Yasmin controversy through official statements and press releases between 2010 and 2014. This study provides an analysis of these documents and how risk information about drospirenone-containing pills has been presented to the public. The analysis addresses a gap in our knowledge about cultural factors that impact contraceptive risk assessment. Prevalent risk models used by professionals are highlighted and examined through the use of critical discourse analysis methods. More specifically, this paper highlights the main strategies used to put drospirenone risks into perspective and classify it as safe. I argue that while risks related to pregnancy and the postpartum period are overly-emphasized, other risks are downplayed through a selection process underscored by normative beliefs about women's bodies and sexuality. Future research needs to address consumer perspectives and bridge the gap between lay and scientific risk/benefit assessment of oral contraceptives.

Drospirenone detected in postmortem blood of a young woman with pulmonary thromboembolism: A case report and review of the literature.

Progestin/estrogen oral contraceptives have some side effects, including venous thromboembolism. To alleviate side effects, improvements have been made to low-dose oral contraceptives, including reductions in the amount of estrogen and/or changes the type of progestin. A compound drug containing 3mg drospirenone and 20µg ethinylestradiol (DRSP/EE20, YAZ®) was released in overseas markets in 2006, and in Japan in 2010 as a newly developed low-dose medicines. This drug is expected to have lower side effects. We received a medicolegal autopsy case of a young woman who had been prescribed YAZ for dysmenorrhea for 17months. The autopsy revealed a blood clot in her pulmonary artery bifurcation. Blood screening by ultra-performance liquid chromatography-mass spectrometry analysis did not detect any medicinal toxicants. However, from police investigations, it is strongly believed that she had been taking YAZ. Therefore we performed a single ion resolution mode assay and detected DRSP. A quantitative analysis revealed 32.3ng/mL of DRSP. As no other cause of the pulmonary thromboembolism was evident, we consider YAZ as the likely cause of the pulmonary thromboembolism. Recent reports from the past few years suggest a higher risk of venous thromboembolism with DRSP/EE20 than earlier progestin/estrogen oral contraceptives. Comparing the risk associated with DRSP/EE20 and DRSP/EE30, one report found no differences and another report showed DRSP/EE20 was associated with a higher risk than DRSP/EE30. No cases of thrombosis caused by progestin alone have been reported. But comparing the risk between DRSP/EE20 and other progestins/EE20, two studies reported DRSP/EE20 had a higher risk than other progestins/EE20. The incidence of venous thromboembolism is highest in the first year of use and decreases thereafter. Because DRSP/EE20 has been on the market for only a couple of years, it is necessary for clinicians to use the drug carefully and accumulate more side-effect data. It is important for forensic scientists to confirm all of the prescribed drugs in autopsy cases, search the risks of identified drugs, particularly new drugs, and provide relevant case information in a timely manner.

Efficacy and safety of an oral contraceptive containing ethinylestradiol 20 µg/drospirenone 3 mg (24/4 regimen) in three indications in the People's Republic of China: a comparison with international studies.

While combined oral contraceptives are a popular choice in developed Western countries, they are used by only 1% of women who are married or in a relationship in the People's Republic of China. The purpose of this review is to describe the efficacy and safety of the combined oral contraceptive containing ethinylestradiol (EE) 20 µg/drospirenone 3 mg taken in a 24/4 regimen (YAZ®; Bayer HealthCare Pharmaceuticals, Berlin, Germany) by Chinese women and to compare these results with those in women assessed in the international studies. Studies of EE 20 µg/drospirenone 3 mg in three different indications (contraception, acne, and premenstrual dysphoric disorder [PMDD]) have been conducted in Chinese women. The results of these three studies indicate that the EE 20 µg/drospirenone 3 mg combined oral contraceptive is a good long-term contraceptive option in Chinese women, providing 99% contraceptive protection over the observed 1-year treatment period, and additionally had a favorable effect on moderate acne vulgaris and relieved the symptoms of PMDD. The contraceptive efficacy, improvement in acne, and relief from PMDD symptoms observed in these studies did not differ from the effects observed in other international studies of EE 20 µg/drospirenone 3 mg, indicating that EE 20 µg/drospirenone 3 mg is as effective in Chinese women as in other ethnicities. Further, EE 20 µg/drospirenone 3 mg demonstrated a similar safety and tolerability profile in women enrolled in the Chinese and international trials, with no unexpected adverse events reported in any of the three Chinese trials. Overall, the efficacy, tolerability, and degree of non-contraceptive benefits with EE 20 µg/drospirenone 3 mg appear similar in Chinese women when compared with those reported in larger studies done at other international centers.

The comparative study of Yaz and Ovocept-ld on patients with simple ovarian cysts referring to Iran-Isfahan Shariati Hospital.

BACKGROUND: Functional ovarian cysts include follicular, corpus luteum, and theca lutein cysts are the most common adnexal masses (about 50%) in women of reproductive age. Treatment with the combined monophasic oral contraceptives reduces functional ovarian cysts. Yaz (drospirenone/ethinyl estradiol) is a low-dose combined oral contraceptive pill containing 20 µg ethinyl estradiol and 3 mg drospirenone. In addition to contraceptive effects, Yaz has anti-mineralocorticoid and anti-adrenergic effects. Ovocept- low-dose LD is also a low-dose combined oral contraceptive drug containing 30 µg ethinyl estradiol and 3 mg norgestrol. Ovocept-LD has some side-effects such as weight gain, spotting, breast tenderness, nausea, and headache. MATERIALS AND METHODS: Being a clinical study, the present research was carried out on 42 patients with the simple ovarian cysts from 2010 to 2012. 84 Patients were assigned to A and B groups. Group A received Yaz once a day for a period of 28 days and group B received Ovocept-LD once a day for a period of 21 days. After treating by Yaz and Ovocept-LD, Cysts were evaluated by ultrasound. Results were analyzed by the SPSS software. A P < 0.05 was considered the significance threshold. RESULTS: Obtained results indicated that both Yaz and Ovocept-LD had an effect on the simple ovarian cysts. Statistical tests, however, has shown that the effect of Yaz has been significantly more than that of Ovocept-LD. CONCLUSION: Given the faster and better recovery effect, and the lesser side effects of Yaz as compared to Ovocept-LD, it is recommended to use Yaz for the simple ovarian cysts.