Yaz side effects have been reported in women who used Yaz birth control pills, which contain drospirenone, a controversial new ingredient that the FDA found was linked to a 75% increased risk of developing blood clots. Blood clots are a life-threatening side effect of Yaz.
UPDATE: The FDA will Update Yaz Safety Warnings
April 2012 — The FDA has recently announced that it will be updating the drug safety information for all birth control pills containing drospirenone. In a statement, they said: “The FDA has concluded that drospirenone-containing birth control pills may be associated with a higher risk for blood clots than other progestin-containing pills.” The FDA will be updating the drug safety information to warn about the increased risk of blood clots associated with drospirenone.
Yaz is a birth control pill invented by Berlex Laboratories, later became Bayer HealthCare Pharmaceuticals, Inc. The U.S. Food and Drug Administration (FDA) approved Yaz in 2006. The Yaz regimen consists of 24 “active” tablets, each containing the following amounts of hormones:
- 3-milligrams drospirenone, a new synthetic version of the female reproductive hormone progestin. This hormone suppresses ovulation.
- 0.02-milligrams ethinyl estradiol, a synthetic version of the female reproductive hormone estrogen
Yaz and Drospirenone
When Yaz was approved, it was the first birth control pill to contain drospirenone, the “fourth generation” of synthetic progestin. Older types of synthetic progestin are norgestrel, levonorgestrel, and norethindrone. All synthetic progestin slightly increases a woman’s risk of developing blood clot side effects. With older types of synthetic progestin, the risk was estimated to be around 4-6 women per 10,000. These numbers were well-established because the medications had a long history of use. When Yaz was released in 2006, researchers quickly discovered that the risk of blood clots was slightly higher — around 10 per 10,000 women.
Drospirenone-based birth control is equally effective at preventing pregnancy compared to these other progestin birth control pills, but a woman may be 75% more likely to develop a blood clot.
Yaz FDA Warnings
In September 2011, the FDA warned that women taking Yaz were 75% more likely to develop a blood clot. This information followed on the heels of several other studies that also found drospirenone had a higher risk of blood clots.
The FDA warning was not the first that agency issued regarding Yaz. The FDA was also concerned about the way that Yaz was advertised. When Yaz was approved by the FDA, Bayer spent more than $270 million running an advertising campaign to promote the drug. You probably remember women popping colorful balloons labeled “bloating” and “acne” and more while singing “We’re not going to take it.” In 2008, the FDA later sent Bayer First Warning Letter, calling these advertisements “misleading.” In 2009, the FDA sent Bayer a Second Warning Letter because the ads “failed to communicate any risk information.” The ads may have misled women into believing that Yaz could improve quality of life, treat all acne, and PMS.
After this advertising campaign, tens of millions of women decided to switch from older birth control pills to Yaz, which had a slightly higher risk of blood clots. As a result, tens of thousands of women developed Yaz side effects, including death. Bayer faces dozens of Yaz lawsuits for deaths caused by this medication.
Yaz and Blood Clots
Drospirenone is known to increase the amount of potassium in a woman’s bloodstream, and in some women this can be toxic. It can also increase the likelihood of developing a condition called Deep Vein Thrombosis (DVT). When a woman has DVT, blood clots form inside veins deep inside the body. Unlike blood clots that form on the surface of the skin (varicose veins), DVT blood clots can break loose and cause life-threatening Yaz side effects. If a blood clot travels in the bloodstream, this is called an embolism. It will travel through the bloodstream until it becomes stuck in a smaller vessel, usually located inside a major organ such as the heart, brain, or lungs. This can cause a heart attack (myocardial infarction), ischemic stroke, or pulmonary embolism. If the blood clot is large, it will stop the supply of blood to large portions of the organ tissue. This can cause organ damage, organ failure, lifelong disability, or death.
Yaz Side Effects
- Blood clots
- Deep vein thrombosis (DVT)
- Venous thromboembolism (VTE)
- Pulmonary embolism
- Heart attack (myocardial infarction)
- Gallbladder disease
- Hyperkalemia (toxic high levels of potassium)
- Irregular heartbeat (heart arrhythmia)
- Psychological trauma