In October 2008, the FDA released a warning letter to Bayer Healthcare president and chief executive Reinhard Franzen in response to Yaz side effects and efficiency. The Division of Drug Marketing, Advertising, and Communications (DDMAC) reviewed two broadcast television advertisements released direct-to-consumer, and the DDMAC stated the commercials were misleading. The seriousness of the risks to patients taking the medication was minimized, and Bayer overstated the effectiveness of the drug. The misrepresentation was non-compliant of the Federal Food, Drug, and Cosmetic Act, 21, U.S.C. 352(n), 352(f)(1), and 321(n).
The FDA-approved usage and indications for the medication is for women of child-bearing age that want to use an oral contraception. While it has been approved for use in premenstrual dysphoric disorder (PMDD), its helpfulness has not been evaluated for use in women using it for four or more menstrual cycles. However, the medication’s effectiveness in treating premenstrual syndrome (PMS) has not been evaluated. It has also been approved for the treatment of women that want an oral contraceptive and suffer from acne vulgaris.
Yaz side effects include serious cardiovascular risk for smokers with an increase in risk as the woman ages. Women over the age of 35 are strongly urged not to smoke while using oral contraceptives. Gallbladder disease and hypertension are common co-morbidities in Yaz users. Other warnings include arterial and venous thromboembolic and thrombotic events, and hepatic neoplasia. Moreover, because the oral contraceptive contains high levels of drospirenone and progestin, users may be at higher risk for hyperkalemia, which can lead to serious health and heart problems. It is advised that women taking the drug should increase their potassium intake.
One TV ad titled “Not Gonna Take It” begins by stating the medication is 99% successful as an oral contraceptive and produces lighter, shorter periods. Then it says, “But did you know… that [it] could do more?” Images depict women energetically and playfully singing while punching, kicking, and pushing words often used to describe symptoms such as bloating, anxiety, and irritability. Both commercials claim to reduce common symptoms of PMS while minimizing Yaz side effects; however, the medication has only been approved to relieve symptoms of PMDD not PMS.
The catchy name and chic marketing minimize the life threatening Yaz side effects. The oral contraception is linked to stroke, blood clots, pulmonary embolisms, liver disease, and abnormal uterine bleeding. Women with a history of hypertension, breast cancer, or liver dysfunction should not take the medication. Complications from the drug are responsible for almost 50 deaths in the United States and Canada, with the youngest victim being only 14-years old.
As of June 2013, Bayer has not recalled the potentially fatal medication. Bayer is directly connected to the FDA’s advisory committee raising concerns that the FDA is not doing enough to protect the health and lives of women. The obvious conflict of interest resulted in nothing more than 4 lines added to the label concerning the risk of blood clots. To date, over 11,000 people have filed lawsuits against Bayer. The pharmaceutical giant has settled thousands of lawsuits for an estimated $750 million.
Families of user’s and many user’s themselves that have been injured or died while taking the medication do have recourse. A personal injury attorney may be able to recoup some of the expenses associated with Yaz side effects. The settlement pace continues to steadily increase as more potentially fatal risks are associated with the medication. Whether the side effects have been minor or fatal, an attorney can answer questions as to whether or not legal representation is a reasonable option.