By Kim Smiley
Deaths of 24 Canadian women associated with the use of Yaz and Yasmin birth control pills have been making headlines in recent weeks. South of the border in the US, more than $1 billion has already been paid out to settle thousands of lawsuits over alleged side effects. Yaz and Yasmin are drospirenone-based birth control pills that are the most widely prescribed birth control pills worldwide so any concerns with the safety of the medication are alarming.
This issue can be analyzed by building a Cause Map, or visual root cause analysis. A Cause Map lays out the many causes that contribute to an issue in an intuitive way that illustrates the cause-and-effect relationships. The first step in the Cause Mapping process is to fill in an Outline with basic background information and to determine how the problem is affecting the overall goals of the organization. In this example, side effects from the pills have been reported to have caused deaths and injuries. Lawsuits associated with the side effects, specifically blood clots, have cost the drug manufacturer huge amounts of money as well as generated significant negative publicity, neither of which are outcomes a company is hoping for.
The complaints about severe and potentially deadly side effects have been focused on blood clots. Blood clots are a known potential side effect of using any birth control pills. It is believed that the estrogen used in birth control pills increases the clotting factors in blood making blood clots more likely. The reason these specific pills are making headlines is that researchers have found that drospirenone-based birth control pills have a higher risk of blood clots than other birth control pills. Researchers have estimated that the risk of blood cloths is 1.5 to 3 times higher with drospirenone-containing pills than with some other birth control pills.
For perspective, the FDA has stated that if 10,000 women who are not pregnant and do not use birth control pills are followed for one year, between 1 and 5 of these women will develop a blood clot and for women using birth control pills the range is 3 to 9. But, and in my opinion this is a pretty big but, it’s worth knowing that the risk of blood clots during pregnancy is estimated to be 5 to 20 out of 10,000 and it’s even higher during first 12 weeks postpartum; estimated to be 40 to 65.
Please talk to your doctor if you have any concerns about blood clots or questions about whether a particular birth control pill is safe for you, especially if you think you may have other risk factors for blood clots. If you’re curious about the symptoms of a blood clot or about other risk factors you can get more information here.
Please click on “Download PDF” above to see a high level Cause Map of this issue.