Yaz and the FDA: A Timeline of Problems

Yaz, approved over a decade ago, has a long history of warnings and problems with the Food and Drug Administration.  The following is a summary of the issues that Bayer has had to address with regard to advertising and safety.

2001:  The FDA approves Yaz as an oral contraceptive

2003:  The FDA found that Yasmin advertisement were misleading, suggesting that they were a safer alternative to other birth control pills, and that the commercials minimized some of the risks and risk factors of Yasmin, such as dangers from elevated potassium levels

2006:  Yaz is approved by the FDA as an oral contraceptive and for the treatment of Premenstrual Dysphoric Disorder.  Early in 2007, it is also approved to treat moderate acne.

2008:  Bayer is issued a warning letter from the FDA regarding their TV advertisements, stating the following:

• The visual images distract from a viewer’s ability to properly take note of the serious risks Yaz poses.
• Bayer overstates the efficacy of the drug.
• The advertisements imply that Yaz treats PMS, when the FDA has not approved it for this purpose.  It is only approved to treat the much more serious PMDD.
• The advertisements imply that Yaz treats all types of acne, when it is only approved to treat moderate acne.
• The FDA requests that Bayer correct these missteps in its Yaz advertising, and that it cease running these advertisements immediately as well.

2009:  Bayer spends $20 million in corrective advertising, addressing the issues that the FDA warning letter brought to light.

March 2010:  Bayer updates the prescribing information for Yasmin in the European Union due to four studies that showed increased risk of VTE in women using Yasmin.

March 2011:  Bayer updates the Yaz label to warn that all combined oral contraceptives (not Yaz, or any of Bayer’s other contraceptives specifically) carry an increased risk for VTE.  The new label also states that “however, pregnancy increases the risk of venous thromboembolism as much or more than the use of COCs.”

September 2011:  The FDA announces that it will convene a meeting to discuss the risk of blood clots with oral contraceptives containing DRSP.  This is the result of conflicting studies, many of which showed an increased risk of venous thromboembolism in women taking DRSP.

October 2011:  A Danish study in the medical journal BMJ finds that oral contraceptives that contain DRSP (such as Yaz and its generic equivalents) have an increased risk of venous thromboembolism (VTE).

October 2011:  The FDA releases its drug-safety study report regarding combined hormonal contraceptives such as Yaz, and finds that all oral contraceptives containing DRSP were associated with a significantly higher risk of deep vein thrombosis (DVT) and pulmonary embolism (PE).

December 2011:  The judge in charge of the multi-district litigation for Yaz and Yasmin postponed the beginning of trial and instead ordered mediation to see if a settlement could be reached.

December 2011:  The FDA advisory panel votes to change the label of Yaz, Yasmin, and their generic equivalents to reflect the elevated risk of blood clots with use of DRSP containing oral contraceptives.  However, the panel votes to keep these drugs on the market instead of removing them altogether.

March 2012:  The labels of DRSP containing oral contraceptives are changed to convey the increased risk of venous thromboembolism with these drugs.  Doctors are warned to consider the risks and benefits before prescribing DRSP containing contraceptives to patients.  Also highlighted is the fact that the risk of VTE is highest during the first year of use.  Smoking, obesity, an age greater than 35, and family history of VTE are all factors for VTE that are highlighted in the updated prescribing information.

March 2012:  The British Medical Journal and The Washington Monthly report that four of the FDA panel members that voted to allow drsp-containing birth control pills to remain on the market had some sort of relationship with Bayer, thus resulting in a conflict of interest.  Consumer advocacy groups are trying to have these members removed for a re-evaluation.

Have you taken Yaz and suffered complications?

If so, the defective drug attorneys at Kirkendall Dwyer LLP can help.  You do not have to suffer alone.  You may be eligible to join the thousands of women who are suing to hold Bayer and other manufacturers responsible for their products.  Contact us today for your free case review.