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.
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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