The Meneo Law Group

Overview

YAZ® YASMIN® and OCELLA® oral contraceptives have been widely advertised and marketed to women as safe and effective methods of birth control. For years, women have been subjected to television and other mass media advertising that, according to the FDA, overstated the benefits and understated the risks associated with YAZ® and YASMIN®. Now, it appears that many women who trusted their health and well-being to these drugs have been harmed by their side effects. An increasing number of cases of gall bladder injury, blood clotting disorders such as deep vein thrombosis, pulmonary embolism, stroke and heart attack, as well as other injuries associated with YAZ® YASMIN® and OCELLA® are being reported.

May 31, 2011 FDA Safety Announcement
The U.S. Food and Drug Administration informed the public that it is studying the results of the studies recently published in the British Medical Journal  (see sidebar) as well as earlier studies that indicate YAZ-YASMIN-OCELLA and other drospirenone containing oral contraceptives carry a risk of venous thromboembolism that is significantly greater than that posed by older, second-generation levonorgestrel-containing oral contraceptives.

May 27, 2011 Label Change announced by European Medicines Agency
The European Medicines Agency (EMA) announced that it is updating the product information to inform the European public about the increased risk of venous thromboembolism associated with the use of YAZ-YASMIN-OCELLA and other drospirenone containing oral contraceptives

Misleading Television and Other Advertising
YAZ®,YASMIN® and OCELLA® have been marketed to women through the use of television and other mass media advertising. In the case of each drug, the FDA has deemed much of the advertising as misleading because it understates the risks associated with the use of these oral contraceptives. Among others, the more serious is the risk of developing blood clots and related injuries.

Overstating Benefits and Understating Risks                                           
In October 2008, the FDA issued a "Warning Letter" to Bayer Healthcare Pharmaceuticals, Inc., the manufacturer of YAZ®. In it, the FDA concluded that certain TV ads used by Bayer to promote the sale of YAZ® were misleading in that the content of the ads improperly broadened the indicated uses of YAZ®, overstated its efficacy and minimized the serious risks associated with its use.

YASMIN® has also been the subject of a “Warning Letter” issued by the FDA to its manufacturer. In the case of YASMIN®, the FDA concluded that the television advertising made implied claims that YASMIN® was superior to other combination oral contraceptives while, in the same ads, minimizing important risk information.  

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