Are The Current Warnings About Blood Clot Side Effects Associated With YAZ, Yasmin, Ocella, and Gianvi Sufficient?

Lawsuits Being Filed On Behalf Of Women Who Used These Birth Control Pills Allege There Has Been A Failure To Warn About The Increased Risk

YAZ, Yasmin, Ocella, and Gianvi are oral contraceptives, or birth control pills, that contain ethinyl estradiol and drospirenone. Yasmin and Ocella each contain 30 mcg of ethinyl estradiol and 3 mg of drospirenone, whereas YAZ and Gianvi contain 20 mcg of ethinyl estradiol and the same 3mg of drospirenone.

Both YAZ and Yasmin are manufactured by Bayer HealthCare Pharmaceuticals, Inc. Gianvi, the generic version of YAZ and Ocella, the generic version of Yasmin, are from Teva and Barr Laboratories.  Yasmin was approved by the FDA in May 2001; the generic pill Ocella became available in 2008.  YAZ was approved by the FDA in 2006. 

Case reports made by women and their doctors show that use of YAZ, Yasmin, Ocella, and Gianvi birth control pills is associated with serious side effects involving blood clots, including deep vein thrombosis (DVT) and pulmonary embolism (PE) as well as strokes and heart attacks. Unfortunately, some of these adverse reactions have resulted in death.

YAZ, Yasmin, Ocella, and Gianvi pills contain the new progestin drospirenone (DRSP), which has been referred to as a "fourth generation" progestin. On the positive side, DRSP stops bloating by ridding the body of water. Ridding the body of water, however, can lead to dehydration, and dehydration can make the blood more susceptible to clotting.

That brings us to the negative side; due to the fact that YAZ, Yasmin, Ocella, and Gianvi contain DRSP, these birth control pills have been associated with a higher risk for thromboembolism – and, in turn, the development of deep vein thrombosis (DVT) and pulmonary embolism (PE) as well as strokes and heart attacks. 

Currently, YAZ is the subject of an ongoing international study about this increased risk of blood clots. 

In addition, largely due to the DRSP component, Yasmin made Public Citizen’s “Do Not Use” list twice. The first time, in May 2002, Yasmin was on this drug safety list for the increased risk of hyperkalemia, a serious medical condition caused by increased potassium levels in the blood that can result from DRSP’s diuretic effect. Then in May 2003 Yasmin had the dubious distinction of being on the “Do Not Use” list again, this time for Yasmin's association with blood clots. 

The current version for YAZ, Yasmin, Ocella, and Gianvi package inserts, or labels, contain a “black box” warning for hyperkalemia.

The labels for YAZ, Yasmin, Ocella, and Gianvi do not, however, carry a bolded warning for the increased risk of thromboembolism, nor the resulting DVT and PE events as well as strokes and heart attacks.

Further, in earlier YAZ advertisements Bayer allegedly overstated the benefits and understated the risks of YAZ according to an October 2008 FDA warning letter. As part of a settlement with attorneys generals for 27 states concerning those possibly misleading YAZ ads, Bayer was required to run a "new" $20 million advertising campaign in the first part of 2009 intended to correct previous YAZ advertising claims. Back in 2003, the FDA sent a similar warning letter about misleading ads for Yasmin.

Personal injury and wrongful death lawsuits filed on behalf of women who developed a DVT or PE, or had a blood clot-related stroke or heart attack, allege that the current YAZ, Yasmin, Ocella, and Gianvi labels are insufficient as regards the increased risk of developing blood clots.

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