Yaz is a fourth generation oral contraceptive made by German company Bayer. For those women using Yaz as a birth control, it can also be used to treat acne and symptoms of premenstrual dysphoric disorder. When Bayer first brought Yaz to market the company emphasized these bonuses, but downplayed the risks.

It is now known that Yaz increases the risk that a woman will develop a blood clot, which can be fatal. Although the U.S. Food and Drug Administration (FDA) has not issued a recall due to the dangers, nor has Bayer initiated one voluntarily, many women and advocate groups for consumers have been calling for a complete Yaz recall. They say the drug is too dangerous and should not be on the market at all.

Yaz – Fourth Generation Birth Control

Yaz is an oral contraceptive made by Bayer and belongs to the fourth generation of such medications. All oral contraceptives contain synthetic hormones that trigger various conditions that make becoming pregnant nearly impossible. In a dual-hormone contraceptive like Yaz there are two hormones: a synthetic version of estrogen and of progestin.

Yaz contains ethinyl estradiol as its synthetic estrogen. For a progestin, it uses drospirenone, and it is this compound that makes it a fourth generation oral contraceptive. It is the fourth reformulation of synthetic progestin. It is also drospirenone that causes serious potential health issues in some women and that has led a number of people to call for a Yaz recall.

Bayer first got Yaz approved by the FDA in 2001. The agency approved it to prevent pregnancy, but for women already taking it for this purpose, it is also indicated for treating moderate to severe acne and symptoms of premenstrual dysphoric disorder, like severe moodiness. Bayer came out swinging with Yaz in 2001 and promoted it heavily as a new birth control that could treat acne and mood swings. This combined with downplayed safety concerns would get Bayer in trouble.

The Risk of Blood Clots

Yaz quickly became one of the best-selling birth controls on the market, thanks largely to Bayer’s heavy marketing, which has been heavily criticized for playing up the benefits and minimizing risks. Before long, though, it was discovered that this birth control could also put women at serious risk of developing blood clots.

Blood clots most likely form in the legs. From there they pose no serious risks, but they can move through blood vessels, eventually causing blockages. A blockage in the heart, lungs, or brain can quickly become fatal. These clots can lead to heart attacks and strokes, and either immediate fatalities or serious and lifelong complications.

Although Yaz had been on the market since 2001, the FDA did not issue a warning about the risk of blood clots until 2011. The agency announced in May of that year that it was reviewing safety data and new sources of information about blood clots in women using Yaz. The announcement also stated that all oral contraceptives come with the risk of blood clots, but that new information suggested that risk could be higher with drospirenone.

FDA Action

Many individual women ended up suffering because of blood clots triggered by Yaz. It was on the market for ten years before women were notified of this risk, which means that there was a huge potential for harm. The risk has seemed high enough to some people to warrant a complete recall of the drug from the market. The FDA has so far disagreed.

After the initial warning in 2011, the FDA committed to further investigating Yaz and the blood clot risk and to determine if a recall was necessary. The preliminary results of an FDA study seemed to indicate that the risk of blood clots with Yaz was at least one and a half times greater than with other types of birth control. With the final results by 2012 the FDA concluded that the risk could be as high as three times. Instead of initiating a recall, though, the agency decided to only include additional label warnings and to recommend that doctors and patients weigh the risks and benefits before choosing to use Yaz.

The decision not to remove Yaz from the market came from an FDA advisory committee, which included independent experts. The group Project on Government Oversight, however, followed the meetings and the conclusion by the panel and was highly critical. The group pointed out that some of the members of the committee had ties to the drug industry and even financial ties to Bayer and could not be counted on to make an unbiased decision about recalling Yaz. The group called for the decision to be disregarded because none of these advisors had disclosed their conflicts of interest.

Limited Recall

Although there was no recall over the dangers of blood clot formation, the FDA did initiate a partial recall of Yaz in 2009 over other issues. The FDA, for reasons not clear, did not include the announcement of the recall in the “Recalls, Market Withdrawals, and Safety Alerts” part of its website. It placed the recall notice in a section on enforcement reports, and the recall went largely unnoticed.

The 2009 Yaz recall was over false reports by Bayer that some lots of the drug were within specifications, when in fact they were not. The specifications related to measurements of drospirenone in the pills, the compound now known to increase the risk of blood clots. Bayer averaged several numbers instead of using specific measurements and had to recall thousands of boxes of Yaz as a result.

Although consumers did not win in getting a recall of Yaz completely, many of those individuals affected by blood clots have received a portion of a $1 billion settlement. This is approximately how much Bayer has paid out so far in Yaz lawsuits, although it has consistently refused any wrongdoing or that the drug is any less safe than its competitors. As more evidence comes to light, it may be that Yaz will eventually be completely recalled. It is no longer as popular as it once was and women have other options when it comes to safe oral contraceptives.