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The Safety and Effectiveness of Oral Contraceptives:

Seasonique and Yaz

Courtney Carroll

October 5, 2009

 
          New oral contraceptives such as Seasonique and Yaz claim to provide health and comfort benefits to women such as, reducing the number of menstrual cycles experienced per year, reducing acne, or helping to relieve premenstrual dysphoric disorder (PMDD) symptoms for its users. This all sounds wonderful but are these oral contraceptives actually safe and are the claims made to attract consumers accurate?   

What the Seasonique website claims:

          Seasonique was released in 2006 and has become popular for those women interested in the perk of reducing the number of menstrual cycles from twelve to four per year. Seasonique claims to be 99% effective in preventing unwanted pregnancies. The pill packs include three months of “active pills” that contain estrogen and progesterone. These hormones prevent women’s bodies from releasing an egg or going through ovulation. Following the three months of once-a-day “active pills” is one week worth of “inactive pills” which contain low-dose estrogen. The hormone withdrawal that the female body experiences during this week of pills causes the bleeding known as a “withdrawal bleed.” Risks of Seasonique, like any other oral contraceptive, include risk of blood clots, stroke, and heart attack. (https://www.seasonique.com/about/what-is-seasonique/)

What the Yaz website claims:

          Yaz was also released in 2006 and has become one of the most widely used OC pills in the US and advertises as “Beyond Birth Control.” (www.yaz-us.com) While it does not offer fewer cycles per year, its benefits are significant and include treating PMDD symptoms and helping to treat moderate acne. These claims are very appealing to those women who suffer from PMDD or acne and are also interested in an oral contraceptive. Like Seasonique, Yaz claims to be 99% effective in preventing unwanted pregnancies by preventing ovulation and causing changes in the cervical mucus that makes it difficult for sperm to penetrate or for an egg to implant if an egg happens to be released. The PMDD symptoms that Yaz claims to treat may include; “anger, irritability, depressed mood, anxiety, bloating, headaches, changes in appetite, and muscle aches.”  (http://www.yaz-us.com/consumer/about_pmdd/index.jsp) Again, Yaz warns against risks such as blood clots, stroke, and heart attack. Yaz also contains a hormone called Drospirenone (DRSP), which could cause increased potassium, so caution is given to those women who have kidney, liver, or adrenal diseases. The Yaz pill pack contains 24 “active pills” with estrogen and DRSP followed by four “inactive pills.” Yaz claims that since there are only four days of “inactive pill” instead of seven, the body does not go through as much hormone withdrawal, lessening the severity of PMDD symptoms. As for the treatment of acne, it is said that DRSP may work against the “male” hormones in a woman’s body, such as testosterone, which can cause acne. (www.yaz-us.com)

What research says about Seasonique:

          In a study done by Freedolph D. Anderson, William Gibbons, and David Portman (2006), sexually active women of childbearing age, 18-40, were put on Seasonique for a year to determine the safety and efficacy of the oral contraceptive. In their study they had three groups of women, one group (60% of participants) called “switchers” were women who had been on other birth control pills during the six months prior to the study. The second group was called the “fresh starts,” (10% of participants) these women had never been on an oral contraceptive. The third group was called “prior users” (26% of participants) consisting of women who had been on oral contraceptives, but not during the past six months.

          In this study, almost half of the patients (including women from all three of the research groups) discontinued use of the oral contraceptive before the end of the trial year. The largest percent, 16%, of patients discontinued use due to “adverse events” such as intermenstrual bleeding, menorrhagia (extremely long or heavy menstrual cycles), increased weight gain, mood swings, or acne. There was a median of about eleven days of unscheduled bleeding or spotting in the first cycle of Seasonique, but that number was markedly reduced by the second cycle. (Anderson et al., 2006)

           Kaunitz et al. also discuss the finding that unscheduled bleeding or spotting reported by research participants decreases significantly after the first few cycles of extended regimen pills such as Seasonique. According to Kaunitz et al. “the potential benefits of extended regimen OCs, which include fewer scheduled withdrawal bleeding episodes per year and greater ovarian suppression, should be considered along with the potential increased risk of unscheduled bleeding, particularly during the first cycles of use.” (2009, pp. 354)  Only 0.5% of participants discontinued use because of pregnancy, and only one pregnancy was deemed “compliant use” of the contraceptive. So, it was confirmed that Seasonique was >99% effective for preventing unwanted pregnancies. It was also determined that extended oral contraceptive cycles have the ability to sometimes reduce the hormone withdrawal symptoms, or PMS, even though that was not one of Seasonique’s main selling points. (Anderson et al. 2006)

What research says about Yaz:

          In September of 2008 The Journal of Reproductive Medicine released an article describing the effectiveness and safety of Yaz as an oral contraceptive. They claim Yaz “has been shown to provide effective contraception and to have a good safety profile.” (Mishell, 2008, pp. 721) The safety of drospirenone was a concern, but in two large studies, two major health concerns, hyperkalemia (high levels of potassium in the blood that in extreme cases can lead to abnormal heart rhythms) and blood clotting, were investigated. It was determined that drospirenone contained in Yaz was not associated with an increased risk of either ailment. (Mishell, 2008)

          In a 2008 article from the Journal of Psychiatry and Neuroscience, Teri Pearlstein and Meir Steiner discuss their findings from a study testing the effectiveness of Yaz in decreasing PMDD symptoms. They state that PMDD is many times severe enough to disrupt the daily living of 5% of women, while 20% experience moderate PMDD or PMS. The etiology of PMDD has to do with the dysregulation of serotonin systems in the woman’s body. It was found that Yaz, containing ethinyl estradiol as well as drospirenone, was superior in reducing PMDD/PMS symptoms when compared to a placebo by regulating those serotonin systems. The side effects that were noted were nausea, spotting between cycles, and breast tenderness/pain. (Pearlstein and Steiner, 2008)

          There has also been documentation of the successful nature of Yaz in the treatment of moderate acne. Oral contraceptives contain progestins that can sometimes cause women’s acne to worsen instead of improve, but Yaz has seemingly combated this problem. Yaz contains “antimineralcorticoid and antiandrogenic effects” (Rich, 2008, pp.14) which serve to minimize the negative effects of the progestins. In studies, Yaz versus a placebo, Yaz had a 42%-46% reduction rate of moderate acne. (Rich, 2008)

Recent Concerns regarding Yaz:

          More recent information on the efficacy and safety of Yaz has not put the contraceptive in such a positive light as these earlier studies might have. In February of 2009, an article from the British Medical Journal was released and stated that, “Bayer Healthcare Pharmaceuticals has agreed to spend $20m to correct misleading direct to consumer advertising of its birth control pill Yaz, the most popular birth control pill in the United States, with sales of about $616m last year.”  (Tanne, 2009) The FDA and various attorneys negotiated to reach an agreement with Bayer to spend a set amount of money correcting misinformation that was presented and it also added “new requirements to a 2007 agreement about problems related to Bayer’s non-disclosure of safety risks associated with its marketing of Baycol, which was withdrawn in 2001.” (Tanne, 2009) Thomas Abrams from the FDA said that there were two commercials for Yaz that “are misleading because they broaden the drug’s indication, overstate the efficacy of Yaz, and minimize serious risks associated with the use of the drug.” (Tanne, 2009)

          An article from the New York Times from just a few weeks ago expands on the concerns brought to light about Yaz. According to Singer (2009), there was a Bayer-sponsored study done in Europe to investigate the cardiovascular risks of the progestin drospirenone (found in Yaz), but the study concluded that there was no difference in risk between drospirenone and another progestins that have been used for decades. Singer also highlights two studies that were just recently published in the British Medical Journal that used “Danish and Dutch women” and “found a higher risk of venous blood clots for women taking newer progestins, including drospirenone.” (Singer, 2009) Obviously these studies have come to conflicting conclusions and surely as a result of this safety concern being raised, many researchers will continue to study the safety and efficacy of Yaz.

          Conclusion:

          While the claims of fewer, lighter menstrual cycles, reduced symptoms of PMDD, treatment of acne, and obviously birth control seem too good to be true, it might just be that good for a few lucky women. While these benefits are impressive and desired by many, care should to be taken when the decision is made to begin the use of one of these oral contraceptives. There are serious risks of adverse health conditions as well as annoyances such as break through bleeding and spotting. The studies seem to support the claims made by the respective oral contraceptive companies for the most part. Seasonique seems to have less controversy surrounding its safety at this point in time. Yaz may have a greater number of benefits but its risk also may be slightly higher. While Seasonique’s efficacy seems to improve with continued use, Yaz may introduce slightly more harmful risks in the long run.

 

 

 

 

 

 

 

 

References

Anderson, F.D., Gibbons, W., & Portman, D. (2006). Safety and efficacy of an extended-          regimen oral contraceptive utilizing continuous low-dose ethinyl estradiol.   Contraception,           73(3), 229-234.

Kaunitz, A.M., Portman, D.J., Hait, H., & Reape, K.Z. (2009). Adding low-dose estrogen   to the           hormone-free interval: impact on bleeding patterns in users of a 91-day extended           regimen oral contraceptive. Contraception, 79(5), 350-355.

Mishell, D.R. (2008). YAZ and the novel progestin drospirenone. The Journal of Reproductive           Medicine, 53(9), 721-728.

Pearstein, T., & Steiner, M. (2008) Premenstrual dysphoric disorder: burden of illness and           treatment update. Journal of Psychiatry and Neuroscience, 33(4), 291-301.

Rich. P. (2008). Hormonal Contraceptives for Acne Management.  Cutaneous Medicine   for the           Practitioner, 81(1S), 13-18.

Seasonique General Website: www.seasonique.com.

Singer, N. (2009, September 25). Health Concerns Over Popular Contraceptives. New York           Times, p. B1.

Tanne, J.H. (2009) Bayer to spend $20m to correct misleading advertising for oral contraceptive           Yaz. British Medical Journal, 338.

Yaz General Website: www.yaz-us.com.

 

 

 

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