Texas Yaz LawsuitNovember 6, 2011 — Several popular brands of oral contraceptives are under renewed scrutiny, as two Food and Drug Administration (FDA) committees meet later this week to discuss potentially changing the drugs’ safety labeling and prescribing information.

The evidence is growing that they may be more dangerous than older types of contraceptives. The newer class of pills contains drospirenone, which is a synthetic form of the female sex hormone progestin. Although all oral birth control pills that contain progestin increase a woman’s risk of developing a blood clot, the risk was relatively small with the older form of synthetic progestin — known as levonorgestrel.

The FDA has recently announced the preliminary results of a study that followed more than 800,000 women, comparing the incidence of blood clots in women who were using drospirenone versus levonorgestrel. The study found that a woman has a 1.5-fold increased risk of developing a blood clot. What does this mean in real numbers? The increased risk is small — for every 10,000 women, 10 women taking drospirenone will develop a blood clot, compared with 6 women taking levonorgestrel. Though that seems minor, because the two types of medication are just as effective at preventing pregnancy, it seems probable that many women would choose the birth control pill that has fewer side effects.

Much of the reason for the intense scrutiny of these medications is because the manufacturers of the two most popular drospirenone-containing birth control medications, Yaz and Yasmin, ran a $270 million advertising campaign from 2007 through 2010. In these high-budget advertisements, the FDA found that women were misled into thinking that they were safer than other forms of birth control, could cure all types of acne, and were approved for the treatment of premenstrual syndrome (PMS). In reality, Yaz and Yasmin have more serious side effects than other types of oral contraceptives, and they are only approved for the treatment of mild acne and the symptoms of Premenstrual Dysphoric Disorder (PMDD).

Part of the reason for the aggressive advertising campaign is because women in the U.S. spend nearly $3.4 billion on contraceptives every year. Indeed, the advertising campaign was successful at convincing women to use the newer types of birth control pills — Yaz and Yasmin were the most popular birth control pill in 2008 and 2009.

The FDA issued the drug-manufacturers with three warning letters regarding the advertisements, saying that they minimized the risk-factors and misled consumers. The FDA letters in 2003, 2008, and 2009 detailed an ongoing campaign that minimized these risks and misled countless consumers — women who might have chosen another type of birth control if they realized they would expose themselves to additional risks by using Yaz and Yasmin.

In 2010, the FDA forced the makers of Yaz and Yasmin to run a corrective advertising campaign that included safety information. As a result of this campaign, Yaz sales dropped 50%.

Bayer faces up to 10,000 lawsuits, mostly from women who were misled about the safety of the drugs and suffered serious injury or death as a result.

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