Beyaz: Fortified Yaz

Beyaz is Bayer Healthcare Phamaceuticals’ newest birth control pill. In its latest marketing ploy, Bayer enriched its Yaz product. The new pill includes levomefolate calcium, which is designed to increase folate levels in women to help prevent neural tube birth defects. Neural tube birth defects include spina bifida and encephalopathy.

Prevention of birth defects is a good thing. But like Yaz, Beyaz contains ethinyl estradiol and drospirenone. With this troubling combination, Beyaz also carries the same increased risk of blood clots, pulmonary emboli, deep vein thrombosis, gallbladder disease and other potentially life-threatening side effects.

Do women need “fortified Yaz“?  No. Folate, also known as folic acid, is naturally found in green vegetables such as spinach, asparagus and broccoli. Since the early nineties, the FDA has required adding folic acid to grains and cereals. A U.S. woman can meet her daily requirement of folic acid by eating a bowl of breakfast cereal.   

FDA Taking Another Look at Dangers of Yaz and Yasmin

The Food and Drug Administration approved Yaz and Yasmin based on research that Bayer provided saying that the drugs were safe. We've been saying all along that the research was suspect and that, in fact, the drug is more risky than other birth control pills with no added benefits. The danger, we said, was the drugs' unique ingredient, drospirenone.

In April, two independent studies were published concluding that Yaz and Yasmin are, in fact, two to three times more likely to cause potentially lethal blood clots than competing birth control pills. The studies can be found here and here.

Now the FDA has taken notice. Yesterday, it released a "safety announcement" concerning the drugs. As part of it's "ongoing safety review of birth control pills that contain drospirenone" (Yaz and Yasmin were the first and hold the largest market share), the FDA says it will take another look at the risks the drugs carry. It will look most closely at the risk of death resulting from blood clots:

A blood clot that forms in a deep vein in the body is called a deep vein thrombosis (DVT). A DVT is a rare side effect of taking birth control pills. A blood clot can break loose from the vein, move through the body to the lung, and cause a serious problem in the lung, called a pulmonary embolism (PE). This can lead to death.

The FDA says that it will do two things to see whether Yaz and Yasmin do, in fact, have a higher risk of blood clots and death. First, it will be looking closely at the new studies. Second, it has commissioned its own "large study exploring the association of blood clots with hormonal contraception." It says that the results of that study are "currently being finalized and reviewed."

Depending on what it determines, the FDA could (1) do nothing, (2) work to take the drugs off the market, or (3) order a stronger warning so that women who use the drugs know the risks.

Meanwhile, the 6000 lawsuits brought by women injured after using the drugs march toward trial. The first cases will be tried next year.
 

Civil Justice Group Reports on Yaz

Today a consumer rights group reports on the risks of blood clots, strokes, and heart attacks that Yaz and Yasmin pose to women using these birth control pills.  The California-based group, called The Civil Justice Research Project, also reports on the the federal lawsuits that have been filed against Bayer by the hundreds of women who have suffered serious injury after taking Yaz.  The story mentions our co-counsel on the Yaz cases, A.J. De Bartolemeo of Girard Gibbs, and quotes Mike Danko:

Bayer just isn't telling women what they need to know.  No woman would take Yaz if she knew that it was no more effective than other birth control pills but was more risky.

The article talks about the "corrective" ad campaign the FDA required Bayer to run, noting that -- at least  according to some -- Bayer's corrective commercials were "too confusing and jargon-filled to be effective." The article links to one of the commercials.

Yaz and Yasmin Lawyers Team Up

We're excited to report that The Danko Law Firm has teamed up with the Yaz lawyers at Girard Gibbs LLP in San Francisco to jointly represent the victims of Yaz and Yasmin in lawsuits against Bayer.  Girard Gibbs is a nationally known class action firm with a long history of representing those harmed due to the wrongdoing of large corporations.

Together we've launched a new blog to help spread the word about the dangers of these drugs and to provide information about the pending lawsuit.

Follow our Yaz blogging at the new site, Yaz On Trial.

FDA's Role In Approving Yaz and Yasmin Examined

The legal talk show Lawyer2Lawyer invited Mike Danko and an FDA expLawyer2Lawyer Podcastsert, Professor James T. O'Reilly from the University of Cincinnati College of Law, to discuss Yaz and the Yaz lawsuits.  Mike talked about the lawsuits while Professor O'Reilly provided his insights on what the FDA does and, more importantly, does not do when approving a drug for the market.

Bayer was invited to come on the show but didn't accept.

It is an interesting discussion that can be heard on line.

Yaz Lawsuits Pile Up

The San Francisco Daily Journal has reported on the status of the Yaz litigation.  The paper interviewed a number of Yaz lawyers, including Mike Danko.   Susan Galinis spoke about her lawsuit:

I'm hoping to get the word out to other women about how dangerous that drug is. . It devastated my whole life.

As usual, Bayer delined comment about its drug, except to offer the usual lawyer-speak:

Bayer's oral contraceptives have been and continue to be extensively studied worldwide and are safe and effective when used according to product labeling.

Yaz and Yasmin: Drug Company Places Profits over Safety

The trendy Yaz and Yasmin birth control pills are unlike any others because they contain a new synthetic hormone, drospirenone. Bayer has aggressively marketed the drugs, especially to young Yazwomen, as a cure for everything from acne to pre-menstrual syndrome. Unfortunately, Bayer did not adequately test the drug before bringing it to market, and it now ignores two studies on Dutch and Danish women suggesting that the drugs are more dangerous than other birth control pills that don't contain the synthetic hormone. 

Women who take Yaz or Yasmin have suffered a list of harmful side effects. One of the most common is blood clots. Blood clots may lead to debilitating strokes, pulmonary emboli and heart attacks. Women on Yaz or Yasmin have also been stricken by disease and damage to the gallbladder, liver, and pancreas, among other conditions.

The Food and Drug Administration has now decided that Bayer's television commercials were misleading, because they undersold the risks of the drug while at the same time overstating its benefits. In addition, the consumer protection group Public Citizen warns all women against using either Yaz or Yasmin, and instead suggests sticking to a pill that does not contain drospirenone.

Yaz and Yasmin are no more effective than traditional birth control drugs, but they appear to be more dangerous. Nonetheless, because of Bayer's aggressive and misleading advertising, they are now Bayer's most popular drugs. In fact, the drugs are the most popular birth control pills in the world. Last year alone, Bayer sold $1.8 billion worth of Yaz and Yasmin .

Not surprisingly, with that type of money on the line, Bayer continues to promote the drugs, regardless of their risks.

One Yaz Victim's Story

I admire clients who find the strength to tell their stories on television.  It takes guts. When Susan Galinis said she wanted to do just that, I warned her that it would be difficult and, well, embarassing.  She said she didn't care.  If she could persuade just one woman to switch from Yaz to a traditional birth control pill, it would be worth it.  

On Monday, Susan appeared on local Fox, ABC, and NBC stations. She showed to the cameras pictures that, until now, she hadn't shown to anyone outside her family. 

After Susan's story aired, I received dozens of calls from Yaz survivors who asked me to thank Susan for getting the word out, or to offer her their help and support.  Some called to ask for more information or just to talk about their own experiences.  One talked about a friend she lost to Yaz.  I appreciate hearing from anyone whose life has been impacted by this drug.  

 

We're working on all of our Yaz and Yasmin cases with a Yaz law firm in San Francisco.  We chuckled over the fact that Bayer had no problem speaking to reporters before the first news segment aired. But once Bayer actually saw Susan and heard what she had to say, the company apparently could think of no response and refused to speak with the reporters who produced the later segments.

Susan, you "done good."

FDA Determines Yasmin/Yaz Commercials Misleading

Beginning in July 2003, the Food and Drug Adminstration warned Bayer (or more accurately, Bayer's predecessor, Berlex Laboratories ) that its television commercials for Yasmin were misleading and should be corrected.  The FDA warned Bayer again in 2008, and again in 2009.  Among Bayer's more serious violations, accorYaz Commercial Screen Shotding to the FDA, was that the commercials minimized the risks associated with Yaz while at the same time overstating its benefits -- especially for conditions such as premenstrual syndrome for which the drug was never approved.  According to the FDA:

These violations are concerning from a public health perspective because they encourage use of YAZ in circumstances other than those in which the drug has been approved, over-promise the benefits and minimize the risks associated with YAZ.

 

FDA Warning Re Yaz

Yaz and Yasmin Cause Blood Clots

Yaz and Yasmin cause blood clots that often begin in the deep veins of the legs. A clot, called a Deep Vein Thrombosis (DVT), can break off and move to the brain, where it causes a stroke. If the clot moves to the lung, it causes a pulmonary embolism. If it moves to the heart, it can cause a heart attack.

Within weeks of taking Yaz or Yasmin, women have been stricken by life-changing strokes . For some women, the stroke or heart attack occur without warning. For others, there are warning symptoms. These warning symptoms include:

  • Pain in the calf or the back of the leg (Possible DVT)
  • Sudden headaches (Possible stroke)
  • Unusual swelling in the lower legs (Possible DVT)
  • Chest pains or heaviness (Possible heart attack)
  • Drooping of the eye or mouth (Possible stroke)
  • Weakness in arm or leg or speech problems (Possible stroke)
  • Eye problems and loss of vision (Possible eye clot)

Studies show that the risk of clots is higher with Yaz and Yasmin than other birth control drugs that don't contain drospirenone. Drospirenone is believed to cause strokes in a number of different ways.  For example, besides causing clots in the legs, it is believed that the drug changes the rhythms of the heart, slowing blood flow to the point that it clots there as well. 

Yaz/Yasmin Causes Gallbladder Disease Requiring Gall Bladder Removal

Gallbladder disease includes inflammation and infection (cholecystitis), stones (chollithiasis) or other obstructions or narrowing of the ducts. It appears that Yaz increases the cholesterol level in a woman's bile while, at the same time, decreasing gallbladder movement. That leads to gallstones which can block and damage ducts, requiring that the gallbladder be removed.

Some women function well without a gallbladder. But in about 40% percent of the cases, the women will suffer pain or discomfort for months or even years after the surgery. In one out of five cases, the common bile duct will be damaged during the surgery, leading to fever, jaundice, and chronic pain in the shoulders and abdomen. Further surgery may be needed to correct the complications. Even when a second surgery is not required, many patients who have had their gallbladder removed find that they must permanently change their diets after the surgery because without a gall bladder they are unable to digest the foods they used to eat.

The symptoms of gallbladder disease include pain under the lower breastbone, eventually progressing to under the right breast and then onto the back or between the shoulder blades. Other symptoms include fever, heartburn, nausea and vomiting. The symptoms are typically recurrent.

Yaz and Pulmonary Embolism

Yaz and Yasmin cause blood clots. When a blood clot finds its way to the lungs, the result is a pulmonary embolism. The blood clot cuts off the flow of oxygen and blood to a portion of the lung. A pulmonary embolism can be fatal. In fact, about 15% of all sudden death is attributable to pulmonary embolisms.  In some cases the pulmonary embolism can travel to the brain and cause a stroke.  In less severe cases it can lead to lung damage. The symptoms of a pulmonary embolism include:

  • Sudden shortness of breath, especially after even slight exertion;
  • Rapid breathing;
  • Coughing up blood;
  • Chest pain that mimics a heart attack. The pain gets worse with exercise but remains even after resting; and
  • Rapid heartbeat

A more complete list of symptoms can be found here.