Are Some Birth Control Pills Too Risky?

If you are taking one of Bayer’s birth control pills (Yasmin, Yaz, Beyaz, Safyral) or similar pills such as Gianvi, Ocella, and Zarah, you will want to know about research indicating that these pills have higher risks of side effects than other types of oral contraceptives. While all birth controls contain the hormones estrogen, progestin, or both, manufacturers use different types of each in their products. Bayer’s oral contraceptive products and similar versions contain drospirenone, a type of progestin hormone not found in most other oral contraceptives.

yaz, birth control pills, risks

The Food and Drug Administration (FDA) has raised questions about the safety of oral contraceptives containing drospirenone.^[1] While these products effectively prevent pregnancy, they are significantly more dangerous than other oral contraceptives. FDA Advisory Committee members discussed the growing evidence that drospirenone increases the risk of blood clots (deep vein thrombosis) more than the types of hormones in other birth control pills. Blood clots are very dangerous because they can detach from the vein and travel through the bloodstream, blocking blood flow to the lungs or brain. They can cause disability or death, even in young, healthy women. Several families testified at the meeting about the death of their healthy, young daughters as a result of taking Yaz and similar pills made with drospirenone. You can read the compelling story of one of these daughters at www.LetterstoAnnie.org.

FDA Adds Warning

In 2012, the FDA announced its conclusion that women taking Yaz and other drospirenone-containing oral contraceptives may be at an increased risk for developing blood clots compared to women taking pills containing other forms of progestin. Rather than taking the drugs off the market, the FDA decided to change the labels for Yaz, Yasmin, Beyaz, Zarah, Gianvi, Ocella and other contraceptives with drospirenone to warn patients and doctors about the increased risk for developing blood clots. The FDA is encouraging women to discuss their risk for blood clots with a healthcare professional before deciding which birth control method is best for them. Healthcare professionals are also being encouraged to consider the possible increased risk for blood clots with drosperinone-containing oral contraceptives before prescribing these medications to their patients. Unfortunately, the warning about drospirenone is approximately halfway through a 33 page document, and many patients (and doctors) are unlikely to ever notice them.

The Evidence

Although all birth control pills can cause blood clots and contain a warning about that risk, the FDA has reviewed six recently published studies published studies to evaluate whether these problems are higher with oral contraceptives containing drospirenone. Four of those six studies showed higher risks. Two studies published in 2009 reported that taking oral contraceptives containing drospirenone increases the risk of blood clots by 1.5-to-2 times compared to taking pills containing the progestin levonorgestrel.^{[2]^,[3]}Additionally, two articles published in 2011 in the British Medical Journal reported an increased risk of blood clots that was 2 to 3 times as high with drospirenone compared to other types of birth control pills.^{[4]^,[5]} In addition,a third article published in the same journal in 2015 found approximately double the risk.^[6]Only two published studies of drospirenone, a study led by J.D. Seeger and a study conducted by J.C. Dinger, report there is not an elevated risk with Yaz and generic versions.^{[7]^,[8]}

What could account for these different findings? The authors of the studies that found no increased risk for drospirenone had financial and professional ties to the manufacturer that makes these pills. Their studies included women with pre-existing risks of blood clots, and the authors did not separately analyze women younger or older than 35, which could have influenced the results. The Seeger study investigated the safety of Yasmin, and compared “ethinylestradiol/drospirenone initiators and medically similar initiators of other oral contraceptives….” The authors did not specify the types of “other oral contraceptives” that were compared to Yasmin, nor did they specify the dosage of estrogen and progestin taken by women in the comparison group. That could have also influenced the findings. The Dinger study compared drospirenone-containing oral contraceptives to pills containing levonorgestrel (a type of progestin), pills containing other progestins, and non-hormonal types of contraceptives. There were several crucial differences in the way that these two studies were conducted and analyzed that might explain why their results were more favorable than the studies by independent researchers. For example, the four studies that reported higher risk of drospirenone-containing pills statistically controlled for the estrogen doses in their analyses.^[^2-5]

In addition to reviewing the six studies, the FDA funded its own large study to further evaluate the relative safety of drospirenone in oral contraceptives. The FDA study reviewed the medical records of 800,000 women taking birth control between 2001 and 2007 and reported that women taking birth control pills containing drospirenone were significantly more likely to have blood clots: drospirenone increases the risk of blood clots from 6 in 10,000 women to 10 in 10,000 women (or 1 per 1,000).^[9] The risk of blood clots associated with Yaz, Yasmin, and other pills with drospirenone were significantly higher than other types of birth control pills among women over 35.^[10] However, the FDA study also found that when they focused only on women taking birth control pills for the first time, drospirenone increased the risk of blood clots and heart attacks, especially for women under 35.

Additionally, the FDA study showed that the birth control patch and vaginal ring were associated with higher risks of blood clots than pills containing levonorgestrel, but tended to be less risky than pills containing drospirenone.

Yaz, Yasmin, Beyaz, Safyral: Higher Cost and More Risk

yaz, birth control, yaz pills, risks When new medications come on the market, they tend to cost more and be widely advertised, and this often gives the impression that they are somehow better. Unfortunately, newer does not often mean more effective or safer because the FDA does not require that new drugs be an improvement over older drugs. Furthermore, the FDA doesn’t even require that they be as effective or safe. Since FDA approval is usually based on patients taking a drug for one year or less, the risks may not be obvious at first. These facts mean new drugs should be met with hesitation and caution.

Bayer advertised Yaz and its other birth control pills in many TV commercials featuring attractive and happy young women, and this resulted in the pills’ widespread popularity for many years. Bayer’s pills and other contraceptive labels warns that women who smoke or have a history of blood clots, heart attacks, strokes, or particular cancers should avoid their contraceptive pills but the research on drosperinone raises questions about the risks to healthy, nonsmoking women as well.

Is there more risk information that has not been made public yet? Plaintiffs’ attorneys wanted to provide confidential documents to the FDA for the agency to consider in their review of Yaz and other birth control pills, but in November 2011, the presiding judge ruled that the documents should not be made available to the FDA or the public. Several of the documents were finally made available two days before the December 8th meeting. One was a report from former FDA Commissioner David Kessler that documented how Bayer had repeatedly misled the FDA when FDA officials expressed concerns about the risks of Yasmin before and after the drug was approved.

Should birth control pills containing drospirenone remain on the market? There is no evidence that they have significant advantages compared to other contraceptive pills that would outweigh the risks of blood clots or heart attacks. If patients and their doctors understood the latest research, why would anyone choose to take those risks?

Table of the FDA Approved Oral Contraceptives Containing Drospirenone:

Name	Generic Name
Drospirenone and ethinyl, Ocella,Syeda, Yasmin, Zarah	Drospirenone 3 mg ethinyl estradiol 0.03 mg
Safyral	Drospirenone 3 mg, enthinyl estadiol 0.03 mg, and leyomefolate calcium 0.451 mg
Beyaz	Drospirenone 3 mg, ethinyl estradiol 0.02 mg and leyomefolate calcium 0.451 mg
Drospirenone and Ethinyl Estradiol, Yaz, Yaz28, Gianvi, Loryna, Nikki, Vestura	Drospirenone 3 mg and ethinyl estradiol 0.02 mg

All NCHR articles are reviewed and approved by Dr. Diana Zuckerman and other senior staff.

FDA Adds Warning

The Evidence

Yaz, Yasmin, Beyaz, Safyral: Higher Cost and More Risk

Table of the FDA Approved Oral Contraceptives Containing Drospirenone:

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