Gianvi is a new type of birth control pill. It is actually the generic form of Yaz, a birth control pill manufactured by the pharmaceutical company Bayer. Though the patent on Yaz does not expire until 2014, Bayer teamed up with the generic drug company Teva Pharmaceuticals to manufacture generic Yaz, under the brand-name Gianvi. When the U.S. Food and Drug Administration (FDA) approved Gianvi in 2010, many women who were taking Yaz switched to Gianvi because it is a cheaper, equally effective birth control. Gianvi and Yaz contain the same active ingredients, dose, and risks. Death is a potential side effect of both Gianvi and Yaz.
Gianvi contains the following active ingredients:
- 0.3 mg of drospirenone, which is the “fourth generation” of synthetic progestin. Unfortunately, drospirenone is the focus of intense scrutiny. It has been shown to increase a woman’s risk of developing blood clots by 75%.
- 0.02 mg of ethinyl estradiol, which is a synthetic version of the female reproductive hormone estrogen
What is the problem with Gianvi?
If you know someone or have a family member who died after taking Gianvi, you are undoubtedly seeking solace right now, as well as information about the medication that caused your loved one’s death. At The Clark Firm, LLP, we have experience negotiating pharmaceutical litigation against the drug companies responsible for the most serious side effects caused by dangerous side effects of their drugs. At this time, there are thousands of pending lawsuits against Bayer, the company responsible for Gianvi side effects.
If your loved one died after taking Gianvi, you are not alone. In 2009, Bayer faced a lawsuit brought by family members of 50 women who died after taking Bayer’s birth control pills. Since 2009, it is highly likely that the number of deaths has continued to grow. Though there is no way to put a price on a life, you have a legal right to seek justice, file a lawsuit, and send a message to the pharmaceutical company responsible for your loved one’s injury.
The problem with Gianvi stems from one new ingredient: Drospirenone. The estimated risk of blood clots is around 10 per 10,000 women taking this drug. With older generations of synthetic progestin, the risk was between 4 and 6 women per 10,000. Though both types of progestin are 99% effective at preventing pregnancy, drospirenone carries a slightly higher risk of developing blood clots.
However, when Bayer introduced Yaz, the brand-name version of Gianvi, tens of millions of women taking an oral contraceptive decided to switch to a drospirenone-containing birth control pill. Why? It likely has something to do with the massive advertising campaign Bayer ran to advertise its new, drospirenone-containing birth control pills.
You may remember advertisements featuring balloons labeled “acne,” “moodiness,” “fatigue,” “bloating,” and more. After these advertisements ran, 97% of women believed that Yaz could treat Premenstrual Syndrome (PMS), a common disorder. Many women also believed that Yaz could treat all acne. In reality, however, the FDA only approved Yaz to reduce mild acne and reduce symptoms of a severe but rare disorder called Premenstrual Dysphoric Disorder (PMDD).
After Bayer ran the advertisements, the FDA sent several warning letters calling the ads “misleading.” The FDA also said that the ads “failed to communicate any risk information.”
Though Bayer later decided to run a $20 million corrective advertising campaign, tens of millions of women decided to switch to the newer birth control pills because they believed that the new birth control could prevent pregnancy and had other “perks” that made it superior to other birth control pills. Yaz was the most popular birth control pill in the U.S. in 2008 and 2009.
In effect, the slightly increased risk of blood clots was multiplied by tens of millions of women. This means that there were probably tens of thousands of excess cases of blood clots, some of which caused death.
Gianvi Side Effects
The most serious Gianvi side effect is death. It is known that in some women, Gianvi increases the amount of potassium in the bloodstream to toxic amounts. This can cause irregular heartbeat and extreme changes to the body’s blood chemistry, which can cause high blood pressure and increase risks of developing blood clots. Sometimes, blood clots break free, travel in the bloodstream, and get stuck in smaller blood vessels in the heart, brain, or lungs, causing heart attack, stroke, or pulmonary embolism. All of these conditions can cause death.