Bayer’s Beyaz Birth Control Pill: New Name, Same Side Effects

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.

Bayer’s popular contraceptives Yaz, Yasmin and Ocella have been plagued by serious (and sometimes fatal) side effects. Yaz side effects include:

• Heart Attack
• Stroke
• Pulmonary Embolism
• Deep Vein Thrombosis
• Gallbladder Disease

Despite these documented problems, Bayer has released a new birth control pill, Beyaz, that is nearly the same chemical formulation as Yaz and Yasmin. Beyaz simply adds Folic Acid (Vitamin B-9) to the Yaz formulation that includes the progestin drospirenone. Recent studies have shown that women using birth control pills like Yaz and Yasmin that contain drospirenone are 64 percent more likely to develop blood clots than women taking birth control pills not containing the drospirenone hormone component.

Dr. Laura Berman via Chicago Sun-Times:

"We still can’t get an adequate safe contraceptive, but men can walk on the moon." — Unknown author, quoted in The Torch, Sept. 14, 1987.

The above piece of wry social commentary was made more than two decades ago, but many would argue that the sentiment still rings true.

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%.

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.

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 Yaz Litigation

Thousands of women have sued Bayer, which makes Yaz, due to the serious side effects listed above.

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

Beyaz versus Yaz

It appears Bayer is attempting to repackage its troubled Yaz birth control pills under a new name and only slightly different formulation. While Beyaz includes folic acid it also includes the dangerous progestin drospirenone.

As Shakespeare wrote: "A rose by any other name would smell as sweet."

Or, in other words: If it walks like duck, quacks like a duck, and looks like a duck, then it must be a duck.

Even after being warned multiple times, it appears that Bayer is continuing to put its own profit ahead of womens’ health and safety.

More Beyaz coverage:

• New birth control pill adds folate [Saundra Young at The Chart via CNN.com]
• New attempt to improve birth control [Dr. Laura Berman at Chicago Sun-Times]
• New Birth Control Pill Beyaz Includes Folic Acid, Columnist Writes [Medical News Today]
• Beyaz Official FDA information, side effects and uses [via Drugs.com]

[More information on Yaz side effects]

(c) Copyright 2011 Brett A. Emison