Yaz, Yasmin and Ocella — New Studies Confirm Old Concerns

According to new studies, the latest generation of birth control pills, including Yaz, Yasmin, and Ocella, put women at a higher risk of blood clots than other types of birth control pills.  These fourth-generation birth control pills carry a two-to-three times greater risk of venous thrombosis, also known as blood clotting, than previous generations of birth control.  The symptoms of venous thrombosis include pain, swelling, and redness in the extremity where the blood clot is located, which is often in the calves, a condition also known as deep vein thrombosis (or DVT).  Venous thrombosis can also lead to blood clots in the lungs, a life-threatening condition known as pulmonary embolism, which is characterized by shortness of breath, chest pain, and anxiety. Yaz, Yasmin, and Ocella have also been shown to cause heart attacks, strokes, and gallbladder disease.

Drospirenone is the progestin ingredient found in this fourth generation of birth control. Pills that were introduced years ago, known as second generation oral contraceptives, contain an older form of progestin called levonorgestrel, which is considered much safer than newer drugs, and lower doses of estrogen than are contained within the original birth control products first marketed decades ago.  The third generation birth control pills, which were introduced during the 1990s, contain progestins such as desogestrel and gestodene, and are perceived as also being less safe than the older second generation formulations.

Drospirenone causes venous thrombosis by increasing potassium which in turn disrupts heart rhythms and slows blood flow, leading to clotting.  According to the FDA, this latest generation of birth control pills does not possess any added benefit as compared to earlier formulations, but do subject patients to substantially higher risks.

Yaz and Yasmin both became popular very quickly after  they were introduced to the market and made Bayer, the company that produces Yaz and Yasmin, billions of dollars.  In order for a drug to become popular so quickly, there must be something that sets it apart from other drugs on the market.  But there was nothing that made Yaz or Yasmin better than second generation birth control pills, but, rather, the success of the pills stemmed solely from aggressive marketing, including marketing that was found by the FDA to be in violation of federal law as it promoted the drugs for unapproved uses.

Bayer specifically intended to make Yasmin and Yaz the birth control of choice for young women.  Bayer marketed Yaz as a lifestyle drug for younger women, with promises of clear skin and freedom from the symptoms of PMS. Yaz commercials featured young, attractive women releasing balloons into the sky and saying “goodbye” to the symptoms of PMS.

Bayer had always intended to market Yaz as a treatment for Premenstrual Dysphoric Disorder (PMDD) as well as mild forms of PMS.  However, the FDA had only approved Yaz to be marketed to patients who had been diagnosed with PMDD, a psychiatric diagnosis involving a very small number of patients, and not to be marketed to treat the symptoms of PMS.  Since 2001, the FDA has warned Bayer that the Yaz and Yasmin advertisements it was running were false and misleading, but Bayer continued to run the advertisements.  In response, the FDA has required Bayer to run a $20 million corrective advertisement campaign in order to inform the public that previous advertisements that focused on the Yaz’s use for PMS were improper and in violation of the law.

Despite the fact that Yaz has run corrective advertisements, the damage to young women has already been done.  Bayer made billions of dollars selling Yaz and Yasmin to young girls, so the $20 million spent on the corrective campaign did not even phase them.  Many young girls asked their doctors for Yaz because they had seen false advertisements promising the alleviation of PMS symptoms.  Bayer targeted these young women and attracted them with promises of clear skin and freedom from PMS, but failed to warn them of the serious risks associated with Yaz and Yasmin.  These women now have been put at risk for very serious illnesses because they were misled by false promises made by Bayer.