Claudia Coffey of Fox 5 in Washington D.C. just reported on a story about another young woman, Jessica, who suffered from a blood clot in her leg after taking Yaz. Jessica says that her leg swelled up about twice its normal size and started turning purple. She was in the ICU for three days and in the hospital for six days. The story also mentions the FDA warning letter for Yaz regarding possible quality control problems in a factory in Germany. (You may remember that this is not the first time the FDA has warned the makers of Yaz.) Ms. Coffey also reported that the FDA sent her an email confirming that they are aware of adverse event reports with Yaz, but that they are unable to disclose whether specific label negotiations to the medication are being conducted.
I just read a story that aired in Tennessee on NewsChannel 5 about a woman named Leah. Leah was a twenty year old student at Tennessee Tech and on her way to becoming a nurse when, last January, her college roommate discovered her passed out in the shower. Leah’s roommate called 911 and told them that she was pale and breathing heavily. Leah woke up and spoke to her mom over the phone, telling her that “she was scared, and that she was tingling all over.” Less than an hour later, Leah passed away.
Ultimately, it was discovered that Leah died of a pulmonary embolism (a blood clot in her lung). When Leah’s family asked how this could have happened to a healthy twenty year old woman, an emergency room doctor informed them that the birth control pill Leah started taking six months before, Yaz, could have caused the blood clot.
Leah’s family is devastated by the loss of their daughter. "She didn't have to die. She didn't have to die because of a pill," said Leah’s mother.
I recently stumbled across a story about Yaz describing another one of its clever advertising campaigns. Bayer Pharmaceuticals, the manufacturer of Yaz, hired Lo Bosworth, a young actress on the popular MTV reality show "the Hills" to be the new spokesperson for Yaz in Canada. The story explains that last year the Hills star spent time in "Toronto and then Vancouver doing media interviews, where she focused on the fact that Yaz can lead to fewer symptoms like headaches and cramps during that time of the month."
This isn't the first time Bayer has attempted to promote Yaz as a treatment for "time of the month" symptoms, but it is something that Yaz has come under fire for in the United States previously. In October 2008, the U.S. Food and Drug Administration (FDA) sent a Warning Letter to Bayer stating that a number of Yaz commercials “encourage[d] use of YAZ in circumstances other than those in which the drug has been approved, over-promise[d] the benefits and minimize[d] the risks associated with YAZ.” The FDA, in its 2008 Yaz warning letter, found that the Yaz commercials made it seem as though the drug could treat PMS symptoms like cramps and headaches, when Yaz was only approved to treat the more severe symptoms of premenstrual dysphoric disorder (PMDD). The FDA also took issue with the fact that Yaz was being advertised as a way to "keep skin clear," suggesting that Yaz could be used to treat all forms of acne, when the FDA had only approved its use to treat moderate acne specifically. As a result of the FDA's findings, Bayer had to run a $20 million advertising campaign to clarify the real uses and possible side effects of Yaz.
Not long after receiving the FDA Warning Letter, Bayer hired Lo Bosworth as a Yaz spokesperson for its marketing campaign in Canada, where the FDA has no jurisdiction. The video below, based off of Bayer’s Canadian press release about Yaz, touts a whole laundry list of "benefits" that Yaz purportedly offers. You have to wonder whether these statements would pass muster with FDA, or whether the FDA would find them to be misleading just as it did with some of the US commercials.
As the Yaz spokesperson, Bosworth stated that “I have to be in control of my life at all times – especially my health. I need to make sure I’m taking care of myself..." For most women, staying in control of their lives and health involves knowing the real risks and uses of a birth control pill before they decide to take it.
Potassium – most of us probably know that we can get potassium from eating certain foods like bananas and oranges, but for those of us whose last biology class was more than a few years back, we may forget what potassium actually does in the body. Potassium is mineral that helps the kidneys function normally and it is also an electrolyte. An electrolyte is a substance that conducts electricity in the body, along with sodium, chloride, calcium, and magnesium. Potassium is crucial for your heart to function properly, and maintaining a healthy level of potassium is important to your health.
So how does this relate to Yaz? The Yaz birth control pill, along with Yasmin and Ocella, contains the synthetic progestin known as drospirenone, which can increase potassium levels in the blood. The problem is that increased potassium levels can lead to a potentially dangerous condition known as hyperkalemia. Possible complications from hyperkalemia include:
Arrhythmias (abnormal heart rhythms)
Cardiac arrest
Changes in nerve and muscle (neuromuscular) control
Women with conditions such as kidney, liver or adrenal disease should not take Yaz because it can cause serious heart or health problems, including hyperkalemia. Other medications can also increase potassium levels in the blood, which could be very dangerous if taken in conjunction with Yaz.
As the FDA said in its 2003 Warning Letter to Bayer (the manufacturers of Yasmin), “Women taking Yasmin must be concerned about drug interactions that will increase potassium, in addition to the drug interactions common to all COCs [oral contraceptives]. Therefore, these women and their healthcare providers must weigh Yasmin's additional health risks when considering Yasmin over COCs [oral contraceptives] without drospirenone.”
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Girard Gibbs LLP and The Danko Law Firm represent women and their families who have been injured by Yaz, Yasmin and Ocella birth control pills.More...
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Claudia Coffey of Fox 5 in Washington D.C. just reported on a story about another young woman, Jessica, who suffered from a blood clot in her leg after taking Yaz. Jessica says that her leg swelled up about twice its normal size and started turning purple. She was in the ICU for three days and in the hospital for six days. The story also mentions the FDA warning letter for Yaz regarding possible quality control problems in a factory in Germany. (You may remember that this is not the first time the FDA has warned the makers of Yaz.) Ms. Coffey also reported that the FDA sent her an email confirming that they are aware of adverse event reports with Yaz, but that they are unable to disclose whether specific label negotiations to the medication are being conducted.
