Yasmin lawsuits

The Yasmin Chronicles: Bad Medicine, Big Money and Bayer

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Perhaps you’ve heard of the Yasmin line (Yaz, Ocella, GIanvi, Loryna, Beyaz, Safyral and Zarah) of birth control pills. For a while they were some of the most highly promoted, highly prescribed on the market. Indeed, they were so highly promoted, Bayer, the manufacturer was slapped with not one, not two, but three warning letters by the FDA for mismarketing this contraceptive, specifically suggesting the drug could be used to treat PMS and acne, when it had been approved for neither. Bayer was also cited for downplaying and failing to communicate the risks of these contraceptives. Though Bayer eventually changed their lifestyle ads promoting Yaz and Yasmin, the damage was already done. The perception that these pills were safer and more effective than older birth control pills was cemented in the minds of physicians and patients worldwide and Bayer had garnered 18% of the coveted birth control market share. A mere 100 million women worldwide use oral contraceptives daily. With the Yasmin line, however, there is 3-fold increase of thrombo-embolitic events over the already high risk associated with the older birth control pills. Compared to women not taking oral contraceptives, the risk for these side effects is 6-fold higher; risks not to be taken lightly.

What Makes the Yasmin Line so Dangerous?

The Yasmin line of contraceptives contain the fourth generation progestin, drosperinone. Unlike previous generations of synthetic progestogens (progesterone-like compounds) derived from testosterone, drosperinone is a completely different animal. Drosperinone is analog for a common drug called Spironolactone (Aldactone),an aldosterone receptor antagonist that tells the kidneys to remove water and salt from the body. It’s a diuretic used to treat hypertension, congestive heart failure, kidney disease and cirrhosis of the liver.

Spironolactone comes with a serious list of side effects, including a condition called hyperkalemia or high potassium levels. Unregulated potassium levels, either too high or too low can cause serious heart rhythm irregularities leading to death, and so, physicians are advised to monitor potassium levels in patients using Spironolactone. Have any young woman using either Sprionolactone or Yasmin ever had potassium levels measured? Nope.

Additional side effects of spironolactone include: GI bleeds and gastritis, agranulocytosis, urticaria, maculopapular or erythematous cutaneous rashes, anaphylactic reactions, vasculitis, mental confusion, ataxia, headache, drowsiness, lethargy, renal dysfunction and Stevens Johnson Syndrome; perhaps not something one wants to give to otherwise healthy young women. Indeed, sprironolactone was prescribed for young women with acne, before becoming a birth control pill and then prescribed along with its analog, Yasmin, rather cavalierly.

Drosperinone is a spironolactone analog, meaning drosperinone binds to and blocks the aldosterone receptor just as spironolactone. In fact, binding affinity studies comparing Yasmin to the older generations of contraceptives, showed that it has 500X the anti-mineralocorticoid (aldosterone receptor) binding affinity of the other contraceptives and is equivalent to the 25mg dose of spironolactone. So, from that information alone, one might prescribe this pill a little bit more judiciously, but when we remember that Yasmin is a combination oral contraceptive that comes a dose of ethinyl estradiol, the synthetic estrogen rife with its own side effects (blood clots and stroke), caution should have prevailed. It didn’t, and many women were injured, likely more so that we know of.

Yasmin Lawsuits

Deep vein thrombosis. As of early 2014, Bayer has settled $1.69 billion in lawsuits for deep vein thrombosis and pulmonary embolisms related to Yasmin. These included over 8000 claimants. Yet to be settled, over 4000 suits remain and likely many more as publicity and recognition of the side-effects increase. It’s important to note that, like with most drug settlements, the pharmaceutical company admits no blame, simply pays the settlements and continues with business as usual.

Gallbladder. Gallbladder disease was recently recognized as side effect, and though, Bayer initially denied a relationship, they are now settling cases there too. Only here, the amounts are paltry in comparison. Bayer has set aside $24 million for gallbladder cases; $2000 per case for disease and $3000 per case when gallbladder removal was necessitated. Currently, there are approximately 8000 of these cases pending. Whether more will emerge is unclear.

Stroke. Most recently in Zapalski vs. Aniol et al, a jury awarded Mariola Zapalski $14 million in a suit against her physician for failing to recognize and warn about the risks of Yasmin. Ms. Zapalski suffered a severe stroke two just weeks after her doctor prescribed Yasmin. She suffered permanent brain damage and now requires 24 hour per day medical care. Compared to the class settlements that range approximately $200,000 per claimant and likely include similarly disabled women, the $14 million is significantly higher. To my knowledge, this represents the first case, outside the class-action cases, against an individual physician for failing to recognize and warn of risk. This may be a new trend, but it is too early to tell.

Why is Yasmin Still on the Market?

Money, pure and simple. As I have reported previously,

The Yasmin line of birth control is one of Bayer’s most lucrative product lines with over 4 million women taking these pills monthly in the US alone. Even with the negative publicity surrounding for these products, revenue for the Yasmin line of products neared 1.1 billion for the first nine months of 2012. After 11 years on the market, total revenue for these products was likely well over $10 billion. If the company pays out $1-2 billion in claims, but makes $10-15 billion, the cost-benefit ratio is skewed in favor of maintaining their market presence. The fines become just another cost of doing business.

What about the FDA?

It goes without saying that the FDA has limited power or interest in regulating these drugs. Particularly where women’s health is concerned, the FDA has exhibited an egregious lack of regulation extending back to the DES tragedies and just about every drug or device marketed towards women since. With Yasmin specifically, attempts to include a black box warning on Yasmin were foiled by industry insiders in 2011, despite the medical experts arguing in favor of the warnings. For more details see: The High Cost of Bad Birth Control.

What Should You Do?

As with any medication, it is up to the patient to understand the risks. Do your homework, read the research, make your decision based on the data not the marketing. Drosperinone based contraceptives may not be worth the risk.

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The High Cost of Bad Birth Control: Yasmin and Yaz Lawsuit News

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As the debate over birth control rages, an often ignored aspect of the debate is safety. Some feminist groups contend that we can’t talk about the dangers of certain oral contraceptives or other hormonal birth control methods lest we give ammunition to the anti-birth control crowd.

“If you’ve seen on TV somebody crying that their daughter died taking birth control pills, and you’re a mom, you may not remember the (particular) birth control pill,” said Diana Zuckerman, president of the National Research Center for Women & Families. “You’ll just say you can’t be on it to your daughter.”

That sentiment couldn’t be more wrongheaded. Of course, we should be talking about the safety of birth control. Indeed, we should shouting at the top of our lungs about the dangers of some oral contraceptives and many medications in general. What good is it to have access to birth control, only to be killed or chronically injured from those pills? Death and grievous injury would seem to defeat the purpose of the entire reproductive rights movement.

We Need Safer Birth Control Options

As we’ve reported previously Yasmin, Yaz and other drospirenone based oral contraceptives (generics Syeda, Ocella, Zarah, Loryna,Gianvi, Safyral and Beyaz) appear decidedly unsafe. No amount of marketing will overcome the safety issues.

As of April, there were over 11,000 lawsuits pending with 14,000 plaintiffs. By October of this year, Bayer, the makers of the Yasmin line of birth control, has agreed to pay $750 million to settle the first 3400 lawsuits. With only 7600 more lawsuits to go, this might be one of the most expensive drugs to date.

The Dangers of Drospirenone

Several large studies (here, here, here) have found that women taking drospirenone based oral contraceptives have a two- to threefold increase in deep vein thrombosis and pulmonary embolism compared to other contraceptives. Bayer contests those results with several company sponsored studies that indicate no such risk. Recent reports of withholding data, question Bayer’s assertions.

AdverseEvents.com, a website that tracks all medication side-effects both from FDA and patient reporting, shows that the Yasmin line of oral contraceptives carry with them a range of very serious side effects, including death.

Adverse events associated with Yasmin

Yasmin, Yaz and Pulmonary Embolism

Notice the number and percentage of deaths, life threatening conditions and hospitalizations compared to other potent and in some cases, already recalled medications.

Pulmary Embolism for Yasmin, Yaz and other Medications

Yasmin, Yaz and Deep Vein Thrombosis

Deep vein thromobisis and Yaz, Yasmin

Why are These Products Still on the Market?

Money.

The Yasmin line of birth control is one of Bayer’s most lucrative product lines with over 4 million women taking these pills monthly. Even with the negative publicity surrounding for these products, revenue for the Yasmin line of products neared 1.1 billion for the first nine months of 2012. After 11 years on the market, total revenue for these products was likely well over $10 billion. If the company pays out $1-2 billion in claims, but makes $10-15 billion, the cost-benefit ratio is skewed in favor of maintaining their market presence. The fines become just another cost of doing business.

What about the FDA?

The FDA relies heavily on some 50 advisory committees to review drug safety. Many of these experts have strong ties to industry. Reports of conflicts of interest abound. In the case of drospirenone, early reports are claiming the decision making was indeed skewed by industry sponsored experts.

At least four and possibly six experts on the panel convened to review the dangers of drosperinone, had financial ties to Bayer.  Subsequently, efforts to remove the Yasmin products from the market failed by four votes: 15-11. Instead the panel voted to increase warnings on the labels of these drugs.

Worse yet, unsealed court documents from lawsuits in Illinois indicate the possibility that Bayer knew of the increased dangers associated with the Yasmin products, as early as 2004 and withheld (and continues to withhold) that data from the FDA. According to reporters at Pharmalot and a report by David Kessler, a former FDA commissioner and current advocate for many of the legal cases:

“For instance, in a draft of the August 2004 white paper, Bayer employees wrote: “Compared to the three other (oral contraceptives), Yasmin has a several fold increase in the reporting rates for (deep vein thrombosis), (pulmonary embolism) and confirmed VTEs…When considering only serious AEs, the reporting rate for Yasmin was 10 fold higher than that with the other products which were very similar in magnitude.” Bayer employees argued in a revised draft that “spontaneous reporting data do signal a difference in the VTE rates for Yasmin and other OC users.”

Who to Trust

It is no longer reasonable for patients to blindly assume an FDA approved medication is safe or right for us (Vioxx, for example). Even research in major medical journals is suspect, with publication bias and outright fraud. Medical decision making is not for the faint of heart.

Luckily data are available online and though still convoluted, there is a degree of information availability never before possible. If you look, you can find the information needed to make a decision on almost any medication. We like and trust the data from Adverse Events. Their sole purpose is to expose and make accessible to the public the risks associated with medication.

Moving Forward

Demand better.  We’ve long since moved away from the age of innocence where medications are concerned. Before deciding on the appropriate birth control method for you or your daughter, do the research, ask the questions and make an informed decision.