Study Finds Yaz, Yasmin, Similar Contraceptives Carry Higher Blood Clot Risk

Birth control pills like <"">Yasmin, Yaz, Ocella, <"">Gianvi and Zarah, all of which contain a synthetic form of progestin called drospirenone, may pose a higher risk of blood clots compared to oral contraceptives made with levonorgestrel, an older form of progestin. According to two new studies published today on BMJ Online First, women who took Yaz, Yasmin and the other drospirenone-containing pills faced a twofold to threefold increased risk of nonfatal blood clots compared to women who took levonorgestrel based contraceptives.

For these newest studies, researchers examined medical claims data among oral contraceptive users in the U.S. and the U.K. In the U.S. study, users of the drospirenone-containing pills were twice as likely to experience nonfatal blood clots as users of the older-generation levonorgestrel-containing pills. That study included women aged 15 to 44 who took a contraceptive pill containing either drospirenone or levonorgestrel after January 2002.

The U.S. research team, led by Dr. Susan Jick of Boston University School of Medicine, compared 186 women who had had a blood clot with 681 who had not. The rate of blood clots in women using drospirenone contraceptives was 30.8 per 100,000 person-years. For women talking levonorgestrel-based pills, the rate was only 12.5 per 100,000 person-years.

In the U.K, drospirenone users faced a threefold higher risk of blood clots. That translated to 23 per 100,000 women in the drospirenone group and 9.1 per 100,000 women in the levonorgestrel group. The women included in the U.K. study were in the same age range as those included in the U.S. study.

This is not the first time Yaz, Yasmin and other drospirenone-containing birth control pills have been tied to a higher risk of blood clots. At least four other studies have found an association between such medications and pulmonary embolisms and deep vein thrombosis.

Yaz, Yasmin and other drospirenone-containing birth control pills have become popular because some women tolerate this type of progestin better, and some side effects, like water retention, are less severe compared to other pills. But drospirenone is known to carry other risks. For one thing, it can impact the body’s potassium levels, which can cause a condition known as hyperkalemia. Women who use contraceptives made with drospirenone should undergo periodic blood testing to monitor their potassium levels, as hyperkalemia can lead to serious heart and health problems. Because of this potential side effect, this type of birth control should not be taken by high risk patients, such as those with renal insufficiency, hepatic dysfunction and adrenal insufficiency.

Adverse Events reported to the U.S. Food & Drug Administration involving drospirenone birth control pills include heart arrhythmias, electrolyte imbalance, hyponatremis, hyperkalemia, hyperkalemic arrhythmias, atrial fibrillation, tachycardia, bradycardia, myocardial infarction, stroke, transient ischemic attack, blood clots, embolisms, and sudden death. These reports include 993 cases of pulmonary embolism (blood clots in the lungs), 487 of deep vein thrombosis (clots in the deep veins), and 229 of other blood clots in women who used either the Yaz or Yasmin birth control pill made by Bayer.

Last week, we reported that U.S. deaths associated with the use of the Yaz and Yasmin birth control pills have exceeded 190. The figure came from the group Bayer Dangers, a coalition based in Germany that monitors the company’s behavior. According to Bayer Dangers, 140 deaths have occurred in Yasmin users, while 50 women taking Yaz have died in the U.S. Many of the victims are young women who had few or no health problems, but suddenly developed blood clots, pulmonary embolisms, the group claimed. It is unclear how many of these may or may not be directly related to the victims’ use of Yaz or Yasmin.

As of February 2011, lawsuits against Bayer claiming that Yaz or Yasmin caused to potentially lethal blood clots and other problems in users topped 6,850 in the U.S. More filings are expected. Many of Yaz and Yasmin lawsuits have been consolidated in he Yasmin and Yaz (Drospirenone) Marketing, Sales Practices and Products Liability Litigation in the United States District Court for the Southern District of Illinois before Judge David R. Herndon (MDL No. 2100). Andres F. Alonso, Esq., a partner in the law firm of <"">Parker Waichman Alonso LLP, was named a member of the Plaintiffs’ Steering Committee in that litigation.

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