Could a Yasmin / Yaz Recall Be in the Offing?

Indianapolis, INThe incredible number of lawsuits involving Yasmin birth control has generated talk about a potential recall. Even so, in the face of 25,000 potential lawsuits and censure from the US Food and Drug Administration (FDA) for overstating the effectiveness of Yaz / Yasmin, manufacturer Bayer continues to sell the product.


The Indianapolis Star reported on 2/8/10 that more than 50 women in the Indianapolis area have filed lawsuits claiming that the product has caused them serious health issues. Some of the women reported blood clots and pulmonary embolisms in their legs and lungs. Several required surgery to remove their gallbladders. Some suffered strokes that left them with lifelong disabilities.

Thirty-seven-year-old Kimberly A. Johnson of Madison, a mother of two, launched one such lawsuit. She took oral contraceptives on and off through the years and had been using Yasmin for about three months in 2007 when she developed back and chest pain.

"I was short of breath just before Thanksgiving that year, and I was having sharp pain when I took deep breaths," she told the Indianapolis Star. "The worst was when I was laying down at night. I thought I was having a heart attack. I thought I was going to die."

Tests soon revealed that Johnson had suffered numerous blood clots in both lungs. Currently on blood thinners and off the birth control, Johnson is hopeful that the blood clots won't return.

Johnson was one of many consumers allegedly influenced by a $20 million marketing campaign undertaken by Bayer from February through July of last year. The ads claimed that the contraceptive products provided health benefits in addition to those approved by the FDA. In response, the FDA ordered that Bayer run a counter-campaign correcting its earlier claims.

Yasmin has been on the market since 2001, and Yaz was introduced in 2006. Both contraceptives contain "fourth generation" steroidal formulations for oral contraceptives based on drospirenone, which the suits claim may lead to high levels of potassium. The resulting medical condition, known as hyperkalemia, can cause arterial blood clots, gallbladder disease, pancreatitis, liver and kidney failure, rapid heartbeat, arrhythmias and other conditions including death, according to the suits.

Bayer officials said the contraceptives are safe when used properly and noted that all oral contraceptives carry warnings of possible side effects.