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Birth Control Pills Yaz and Yasmin Can Cause Serious Health Risks

Fifty years ago, in May 1960, the birth control pill was introduced to America. "The pill" gave women more control over their bodies, but not without certain health risks.

One set of contraceptive pills – Yaz, Yasmin and Ocella – have been found to have particularly dangerous side effects. These drugs are marketed under different names, but are chemically the same. The problem lies primarily with their key chemical ingredient, Drospirenone.

Yaz, Yasmin and Ocella combine estrogen with the synthetic progestin Drospirenone. No other oral contraceptive (or birth control pill) contains Drospirenone. The combination of chemicals in Yaz, Yasmin and Ocella have been linked to potentially deadly side effects.

The side effects from Yaz / Yasmin / Ocella include:

How Does Yaz/Yasmin/Ocella Cause A Heart Attack, Stroke or Pulmonary Embolism (PE)?

Your body needs to clot blood… and blood clotting is a normal bodily function. This function normally stops blood flow from cuts and creates scabs to stop bleeding. The clotting function repairs damage to the skin and other body tissues. However, the chemical combinations in Yaz, Yasmin and Ocella can cause abnormal blood clotting. This results in blood clotting when it is unnecessary and inside the blood vessel, vein or artery. The combination of chemicals in Yaz has been reported to increase the risk of blood clots by more than 600%.

Yaz, Yasmin & Ocella can cause serious side effects

These abnormal blood clots can break away from the blood vessel on which they formed. When these clots break away they travel through the blood stream and can form a blockage or become lodged inside the heart itself. This blockage can starve the flow of blood and cause a heart attack.

If the blood clot lodges in the brain (rather than the heart), it can result in a stroke.

If the blood clot lodges in the pulmonary artery that supplies blood to the lungs, it can result in a pulmonary embolism (or PE).

How Does Yaz/Yasmin/Ocella Cause Gall Bladder Disease?

Women are twice as likely to as men to develop gallstones and gallbladder disease is a dangerous side effects of Yaz, Yasmin and Ocella birth control pills.

Yaz side effect: Gallbladder Disease

The hormones in these birth control pills may increase cholesterol levels in bile and decrease gallbladder movement. This process can create gallstones, which can cause serious problems if they become trapped in the bile ducts.

Laproscopic gallbladder surgery is the most common treatment if women are experiencing frequent gallstones or other recurring problems, including inflammation. Gallbladder removal is another surgical option with its own serious side effects.

Misleading Claims By The Drug Company That Manufactures Yaz

Yaz, Yasmin and Ocella are particularly dangerous because they have been marketed to young women with misleading advertising and false claims. In fact, the Food and Drug Administration (FDA) has sent several letters to Bayer HealthCare Pharmaceuticals, Inc. for what the FDA called "misleading" advertising claims it found "particularly troubling" because they served to "undermine the communication of important risk information, minimizing these risks and misleadingly suggesting that Yaz is safer than has been demonstrated by substantial evidence or substantial clinical experience."

In addition, Yaz, Yasmin and Ocella have been targeted to young women as a means to reduce acne or reduce premenstrual symptoms. In fact, some doctors have prescribed these drugs for non-sexually active girls as an acne fighter alone.

The FDA reprimanded Bayer [in 2008] for overstating the benefits and downplaying the risks of Yaz in television advertisements. The slogan for Yaz was "beyond birth control."

Bayer marketed Yaz to women in their 20s. Commercials cultivated a hip, youthful image set to rock music, and advertised Yaz as a treatment for acne and premenstrual syndrome (PMS).

The Food and Drug Administration (FDA) has sent several warning letters to Bayer HealthCare Pharmaceuticals, Inc. for what the FDA termed “misleading” advertising spots it found “particularly troubling” because they served to “undermine the communication of important risk information, minimizing these risks and misleadingly suggesting that Yaz is safer than has been demonstrated by substantial evidence or substantial clinical experience.”

In the 8-page FDA Warning Letter regarding Yaz dated October 3, 2008 two TV ads were cited as overstating the efficacy of the drug and minimizing the risks and side effects associated with using Yaz. Yaz related lawsuits allege that the warnings were inadequate in fully describing the potential side effects including heart attacks, strokes, gallbladder disease, deep vein thrombosis, pulmonary embolism, cardiac arrhythmias and sudden death. The FDA sent three letters to the makers of Yasmin and Yaz regarding the potential for hyperkalemia in high-risk patients and their failure to clarify that risk.

2003 Yaz/Yasmin FDA Warning Letter

2008 Yaz/Yasmin FDA Warning Letter

2009 Yaz/Yasmin FDA Warning Letter

Yaz and Yasmin have been very popular among young women due to Bayer’s "particularly troubling" advertising targeting young women and unconfirmed "benefits" of these birth control pills.

Ongoing Litigation

The Washington Times reported that thousands of women have sued Bayer — the pharmaceutical giant that manufactures Yaz – because of the serious and deadly side effects and the devastating effects these side effects have on even young women. Thousands of these cases have been consolidated for pre-trial work up in Multi-District Litigation (MDL) pending in the United States District Court for the Southern District of Illinois.

"MDL" is shorthand for "multi-district litigation". Many people may refer to an MDL as a "class action", but there are some important differences between an MDL and a class action.

In a class action, only a few people (the class representatives) sue on behalf of a large number of other people (the class). In multi-district litigation, each individual plaintiff maintains his or her own claim.

Although some states have MDL litigation, most MDLs occur in federal court. For MDLs like Yaz, the process begins when users of the drug begin experiencing dangerous side effects. As these users become injured from this dangerous drug, they begin filing lawsuits across the country. Because these lawsuits each involve similar claims (defective and dangerous drug) and similar injuries (dangerous side effects including heart attack and stroke), the federal court will consolidate all of the claims in front of one judge.

Once the MDL court has been established, all new cases involving the same drug (Yaz or Yasmin) will be transferred to the MDL court.

Lead counsel for the MDL is appointed by the trial judge. This small group of lawyers will manage the pretrial work up of all of the cases (potentially thousands of cases) inside the MDL.

The idea is to have a small number of experienced attorneys handle the pre-trial proceedings for all MDL claimants.

Mark Niemeyer, a partner with Onder, Shelton, O’Leary & Peterson, LLC has been appointed as one of only three lead counsel for this national consolidation of all Yaz and Yasmin birth control litigation.

Mark was selected as one of only three attorneys in the United States to lead this litigation. Mark will be instrumental in developing litigation strategies and managing the thousands of Yaz and Yasmin lawsuits pending in the Multi-District Litigation.

"My role in this MDL is simply a reflection of the commitment of all of us at Onder, Shelton, O’Leary & Peterson, LLC to the women or families of women who suffered grave health consequences after taking Yaz or Yasmin and just how seriously we take all our cases," said Mr. Niemeyer.

Bayer’s Profit Continues To Grow

Despite the thousands of lawsuits and thousands of women devastated by serious side effect, Bayer’s profit continues to grow.

Bayer’s Yaz and Yasmin contraceptives appear to be recession- and scandal-resistant superbrands, if recent reports are to be believed. Bayer hit back at a German newspaper that reported the company was cutting back on pill production due to decreased demand.

***

But Bayer said the report was wrong:

“Revenue from our Yasmin product family continues to rise as planned,” a Bayer spokesman told Reuters on Sunday.

Yasmin is Bayer’s best-selling pharmaceutical product group. In the first quarter of 2009, Bayer reported sales of 319 million euros ($443.2 million) for the Yasmin range, a 7.4 percent year-on-year gain.

Those sales gains came despite the FDA forcing Bayer to spend an extra $20 million on “corrective” advertising to rebuff claims the company previously made that Yaz cures acne and PMS (it doesn’t).

Bayer continues to increase its profits at the expense of thousands of young women across the country. Bayer needs to be held accountable for putting profits and money over safety and lives. Why doesn’t Bayer have to follow the same rules as everyone else?

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(c) Copyright 2010 Brett A. Emison

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