What are the possible side effects of 91-day combination oral contraception?

Updated: Oct 16, 2019
  • Author: Frances E Casey, MD, MPH; Chief Editor: Richard Scott Lucidi, MD, FACOG  more...
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Answer

Answer

The risks of using Seasonale are similar to the risks of other conventional combination oral contraceptives and include an increased risk of blood clots, heart attack, and stroke. The labeling also carries the warning that cigarette smoking increases the risk of serious adverse cardiovascular effects from the use of combination estrogen-containing and progestin-containing contraceptives. The study cited for Seasonique does not report any unexpected adverse events or thromboembolic events; the risk profile is the same as Seasonale.

In 2009, the makers of Seasonique came out with LoSeasonique. LoSeasonique consists of 84 orange tablets containing 0.1 mg levonorgestrel and 0.02 mg ethinyl estradiol and 7 yellow tablets containing 0.01 mg ethinyl estradiol. The risk profile is similar to its sister products Seasonale and Seasonique; however, the risk of unplanned breakthrough bleeding is increased.

In a clinical trial, over a 12-month period, 209 of the 2185 participants (9.6%) discontinued LoSeasonique, at least in part, due to bleeding and/or spotting. This breakthrough bleeding remained consistent over time, averaging 2-3 days of bleeding and/or spotting per each 91-day cycle. The breakthrough bleeding eventually decreased over successive 91-day cycles.

Another 91-day oral contraceptive, Quartette, was approved by the FDA in 2013. A phase-3 clinical trial found this product, a combination of levonorgestrel and ethinyl estradiol, to be 97% effective for the prevention of pregnancy. [13]


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