What is Yaz
Yaz and Yasmin are birth control pills (drospirenone & ethinyl/estradiol) approved by the U.S. Food and Drug Administration (FDA) for the prevention of pregnancy. The contraceptives, which contain the hormone drospirenone, have been the focus of regulators who question their safety. The makers of these oral contraceptives, Bayer, is currently under FDA scrutiny and a wave of Yaz litigation has followed.
To discuss your potential Yaz lawsuit, call Kogan & Associates today if you have taken Yasmin or Yaz and have suffered from blood clots or gall bladder issues.
First FDA Warning
On October 3, 2008, the FDA sent a warning letter to Bayer Healthcare Pharmaceuticals, Inc. (Bayer), the manufacturer of Yaz, insisting that two 60-second television ads running at the time were misleading to consumers. The FDA found that the ads misrepresented the drug’s indication, overstated its efficacy, and minimized the serious risks associated with its use. The ads implied that Yaz could treat PMS and any form of acne, when in reality it is not approved to treat PMS and is only approved to treat moderate acne. Yasmin lawsuits were filed. The ads also did not fully distinguish between PMS and PMDD, which the FDA indicated could be both misleading and confusing to consumers. The artistic design of the ads were also accused of misleading consumers by suggesting that Yaz could completely eliminate the symptoms associated with chronic acne and PMDD – a claim not supported by clinical evidence.
As a result, the FDA requested Bayer to “immediately cease dissemination of violative promotional materials” for Yaz, and “submit a comprehensive plan of action to disseminate truthful, non-misleading, and complete corrective messages…to the audience(s) that received the violative promotional materials.” In response to the FDA, Bayer launched a $20 million corrective advertisement campaign in late January of 2009; however, the company never acknowledged that it engaged in deceptive advertising.
Second FDA Warning
Bayer again pushed the envelope with its advertising of Yaz and in March of 2009, received another letter from the FDA regarding the company’s sponsored links on internet search engines (such as Google). The FDA cited the following violations:
- Failure to communicate risks associated with the use of Yaz
- Inadequately communicating the indications for which Yaz is approved
- Failure to use the full established name as required by federal law
The letter asserted that the sponsored links stated only that Yaz could “prevent pregnancy” and “may help moderate acne” without communicating any risk information as required by federal law. The FDA also voiced particular concern over the failure to communicate risk information in light of the fact that the Yaz package insert contains a “boxed warning.” Boxed warnings are reserved for serious and potentially life-threatening adverse risks associated with a drug or device. In this letter, the FDA again requested that Bayer immediately cease the dissemination of the misleading advertisements and submit a plan for their discontinuation. Furthermore, the FDA urged Bayer to review promotional materials for all other prescription drug products it promotes in the United States and follow the same course of action if it discovered similar violations for those products.
CALL OUR FIRM TODAY TO DISCUSS YOUR POTENTIAL CASE!
Recent FDA Activity
Most recently, the FDA has issued a MedWatch Safety Alert (originally posted May 31, 2011) regarding birth control pills that contain drospirenone, citing a possible increased risk of blood clots. In this warning, the FDA voices concern over the findings of two 2011 studies that evaluated the risk of blood clots in women using birth control pills that contain drospirenone, as well as the findings of a recent FDA-funded study that suggest a 1.5-fold increase risk of blood clots associated with the use of drospirenone. In a September 2011 update to the Safety Alert, the FDA announced a scheduled meeting between the Reproductive Health Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee for December 8, 2011 to further discuss the risks and benefits of drospirenone-containing birth control pills. This meeting will once again put Yaz – and other drospirenone-containing pills (such as Yasmin, Beyaz, and Safyral) – on the hot seat — and sparking Yaz lawsuits throughout the country.
The FDA continues to advise women who take drospirenone-containing birth control pills, such as Yaz, to talk to their doctor before discontinuing use, and to contact their healthcare professional immediately if they develop symptoms associated with blood clots, which include:
- Persistent leg pain
- Severe chest pain
- Sudden shortness of breath.
In addition to its concerns over the major side effects associated with Yaz, the FDA also served Bayer with a warning letter in August 2009 regarding quality control problems at a manufacturing plant in Germany that produces one of the drug’s ingredients.