By Lesley Ranft

As Gabriel F. Zambrano, Attorney at Law and partner at Johnson Leiter & Belsky, Ft. Lauderdale, Florida explains, “Many women today may still not be aware of the risks associated with Yaz and Yasmin, the oral contraceptive drugs. This is a cause of great concern for girls as young as 13 years of age and adults using Yaz or Yasmin.” According to IMS Health, Yaz sales were $616 million (17.7% of the U.S. Market) and Yasmin sales were $382 million (11% of market share) in 2008, signifying the need to better inform widespread users.  In fact, women using Yaz or Yasmin and doctors may not link medical conditions to Yaz or Yasmin side effects. Berlex Laboratories introduced the drugs in 2001. The company was purchased by Bayer Healthcare in 2006. Still, to date, women’s adverse event reports continue to stack up.  As Daniel Gallucci, Attorney at Law, RodaNast, P.C., Lancaster, PA adds, “There are too many drugs today that receive fast track approval by the Food and Drug Administration.  To make matters worse, consumers often do not know about warnings issued by the Food and Drug Administration.  The consumer’s not knowing of the FDA warnings combined with the risks associated with Fast Track Approval, often can lead to large numbers of people being unnecessarily harmed.

Yaz and Yasmin Side Effects

Serious side effects associated with Yaz and Yasmin may include, but are not limited to:

• heart attack
• stroke
• deep vein thrombosis, blood clots
• gall bladder disease
• hypertension
• liver disorder, signified by jaundice and/or discolored urine
• severe allergic reaction
• psychological disorders, including mood swings and depression

The issues surrounding Yaz relate to the drug’s ingredients, including: estrogen ethinyl estradiol and drospirenone, a type of progestin. Yaz and Yasmin are comprised of the same ingredients. The tablet strength of ethinyl estradiol is .03 mcg in Yasmin and .03 mcg in Yaz. The ingredient combination may adversely affect the body’s ability to regulate salt and water. This may have an adverse impact on the heart and/or other bodily functions.

The new package insert provided with YAZ and Yasmin advises that women using the contraceptive should undergo potassium testing following one month of use.   The reason why potassium testing is important is because the drug may alter the potassium level in women. Women who have unsatisfactory potassium levels may experience muscle cramps, fatigue, nausea, diarrhea, frequent urination, dehydration, low blood pressure, confusion, irritability, paralysis, abnormal heart rhythms, heart arrhythmias and potential heart attacks. Appropriate potassium levels are indicative that salt and water is properly regulating.

Yaz and Yasmin have been prescribed by physicians for use as an oral contraceptive or to treat PMS, PMDD or acne for birth control users. Girls as young as 13 years of age have used Yaz and Yasmin.  Some girls as young as 13 years of age have been reported to have suffered from serious side effects because of Yaz/Yasmin. All oral contraceptives have risks, but some of the risks associated with Yaz and Yasmin are elevated when compared with other oral contraceptive drugs.

The Yaz/Yasmin Track Record

In 2003, the Yasmin TV AD denoting “Good Bye Kiss” prompted the first warning letter about the drug’s advertising practices.  In 2008, the FDA issued a safety alert about the elevated risks associated with Yaz/Yasmin. This was seven years after the introduction of the drug. In 2008, the FDA ordered Bayer to cease misleading ads that created false impressions for women interested in using the oral contraceptive drug for PMS. In fact, the ads were misleading in numerous ways. As Gabriel F. Zambrano adds, “The ad campaigns overstated the uses and advantages of the drug. The campaigns failed to underscore the risks associated with the use of Yaz.” For example, Yaz has been suspected to be appropriate for women with PMDD, a premenstrual dysphoric disorder which is different than PMS. Yet, the safety and efficacy of Yaz for the treatment of PMDD has only been evaluated for three menstrual periods. In fact, Yaz has not been approved for the treatment of PMS. Moreover people are at an elevated risk for injury if they have Factor V Leiden. However, only a personal and family health history intake is gathered to screen for Factor V Leiden. The current screening process appears inadequate, at best.    As Daniel Gallucci adds, “We need to reestablish trust in the review process by the FDA before a drug is placed on the market.”

In February of 2009, the Attorney Generals of 27 states came to settlements totaling $20 million. Bayer also initiated a corrective ad campaign. It is not known if a YAZ RECALL will be considered appropriate by the regulating authorities at this time.  The verdict is not out for some Yaz and Yasmin lawsuits involving children as young as 13 years old who have taken the drug.

If you or a loved one has suffered from Yaz or Yasmin, we encourage you to seek out medical attention immediately, secure potassium test results, undergo screening for Factor V Leiden and consult with an attorney that understands the complexities associated with Yaz and Yasmin.