Most birth control pills and devices have a downside. For some, it is as simple as physical discomfort. For others, it can be as severe and disabling as migraine headaches, persistent uterine bleeding, and even kidney failure.
In women of childbearing age who take Yaz and also have a polycystic ovarian syndrome, or PCOS, the risk of developing a dangerous and potentially lethal blood clot doubles. Couple that with women over 35 who also smoke, and risk becomes exponentially higher, leading concerned physicians to refuse to prescribe the pill, even for women who already have two or more children.
According to a decade-long study, among a cohort of more than 43,500 women, researchers concluded that older women, especially those who were obese or who had hypertension and/or diabetes, or displayed other risk factors for heart disease as a result of PCOS, not only had a higher risk of blood clots but that the risk was as high as 77 percent greater than first-generation contraceptives!
Manufactured by Bayer, both Yaz and Yasmin (as well as their generic counterpart, Ocella) contain drospirenone – a potent chemical related to progesterone. Drospirenone is also related to spironolactone, a diuretic, which some researchers consider the drug’s stumbling block when it comes to safety. Diuretics drain the body of moisture, which tends to thicken the blood and promote blood clots.
On a side note, drospirenone is also an anti-androgenic: androgynous characteristics are those which are neither male nor female. But these are not related to Yaz’s greatest dangers. Those come from the formulation and the intensity of dosing (as few as four days of placebo compared with most birth control’s use of seven).
Other side effects include not anaphylactic (allergic) reactions, changes in glucose levels that can increase diabetic problems, gallbladder problems, liver function disturbances, liver tumors, and a worsening of lupus erythematosus. Lupus is the blanket name for a host of autoimmune diseases that cause the body to attack its own healthy tissue. Anaphylactic reactions are almost always fatal if victims don’t have an “epi-pen” (injectable epinephrine) and can’t get to a hospital.
As recently as 2012, Bayer – a German chemical and pharmaceutical giant operating in the United States as Bayer Corporation USA – had, as a result of threatened litigation, resolved more than 1,800 lawsuits against its three birth control formulations, with an average settlement amount of more than $200,000.
In March of this year, according to Reuters, Bayer had agreed in court to settle gall bladder claims filed in Illinois, California, New Jersey, and Pennsylvania for a total of up to $24 million. Payments will be $3,000 to those who had their gall bladders removed, and $2,000 to the approximately 8,000 claimants who experienced gallbladder injuries. This figure may change depending on the number of claimants who ultimately demand redress, as the $24 million is capped.
The cost for damages as a result of blood clots has been agreed on at $1 billion. Under that ruling, Bayer also redrafted labels on its Yaz and Yasmin (and Ocella) birth control pills. As of 2012, 4,800 women had filed requesting settlement of claims.
And as if that wasn’t enough to convince new users to bypass Yaz et al in favor of older but more field-tested birth control methods, legal representatives and medical experts are disconcerted by the “swinging door” status Bayer has with the U. S. Food and Drug Administration, or FDA. The question is: can the FDA deliver a non-biased review of Bayer’s birth control formulations when four of its advisory committee members (and the chair) are on Bayer’s payroll?
This advisory committee has already agreed, 15 to 11, to keep Yaz et al on the market, and 21 to 5 to rework the drug label. Unfortunately, the newest hazard label does little to explain the risk of blood clots. Meanwhile, Bayer has paid out about $750 million to approximately 11,300 consumers who have filed Yaz lawsuits. If that isn’t an admission of guilt, we don’t know what is.