Yaz and Yasmin Investigation

Stueve Siegel Hanson is investigating Yaz and Yasmin. Manufactured by Bayer HealthCare Pharmaceuticals, Yaz and Yasmin (drosperinone & ethinyl estradiol) are "combination" birth controls administered orally to prevent pregnancy. The FDA has also approved the drug for treatment of premenstrual dysphoric disorder and moderate acne. Yasmin was approved by the FDA in 2001 and Yaz in 2006. In July 2008, a generic version of Yasmin called Ocella gained FDA approval and entered the market. The difference between Yaz and Yasmin is the amount of the estrogen. Yasmin contains 30 mcg ethinyl estradiol, while Yaz contains a lower dose of 20 mcg.  

The “miracle drug” Yaz was the top-selling birth control pill in the U.S. in 2008 and 2009 grossing more than $391 million in the first half of 2009 alone, up 44% from the year before.  Despite its popularity, the birth control pill has been linked to serious, potentially fatal side effects, including heart attack, stroke, pulmonary embolism and blood clots.

Birth control medications were developed in the 1960’s; since that time, there have been four main types of progestin used. The progestin used in Yasmin/Yaz is called drospirenone, and is a new fourth-generation progestin which has not been used in any other type of birth control pill to date.

Side Effects

In August 2009, research was released indicating the drospirenone used in Yaz brings an increased risk of potentially deadly blood clots. European researchers reported findings that women taking oral contraceptives containing drosperinone faced a 6.3 times greater risk of blood clots. Yaz induced blood clots can break forth from the wall of the vein and travel in the bloodstream toward the heart, lungs or brain. If they create an obstruction in any key blood vessel the clot can trigger a heart attack, pulmonary embolism and/or stroke. Yaz or Yasmin DVT (blood clot) symptoms should be brought to the attention of your medical provider immediately.

Blood Clot Symptoms  

  • sudden severe headaches
  • unusual swelling or pain in the legs or arms
  • sharp or crushing chest pain or coughing blood
  • eye problems such as blurred or double vision or complete loss of vision
  • pain in the back of the lower leg

The progestin in Yaz and Yasmin can also cause hyperkalemia, an elevated level of potassium in the blood. In severe cases, hyperkalemia can cause cardiac arrhythmia and sudden death. The product labeling and package insert for Yasmin recommend that blood tests be performed to check users potassium level within the first month of use - such blood tests are not necessary for any other types of birth control pills.

Heart Attack Symptoms

  • Chest pain
  • Upper body discomfort in the arms, back, neck, jaw
  • Shortness of breath
  • Nausea, sweating, fainting, vomiting or lightheadedness

Stroke Symptoms

  • Sudden numbness in the face or weakness in an arm or leg
  • Sudden confusion, trouble speaking or understanding
  • Sudden vision problems in one or both eyes
  • Sudden disorientation, dizziness, balance problems or trouble walking
  • Sudden onset of a severe headache

In April 2010, the FDA required Bayer to include additional information on Yaz and Yasmin package inserts regarding the risks of developing blood clots and stroke. Some consumer advocates say the label is still misleading since it cites Bayer-sponsored studies suggesting that Yaz does not pose a greater risk of developing blood clots than do second generation birth control pills.

Additionally, the FDA warned the manufacturer Bayer that its commercials for the birth control minimized the "serious risks associated with use of the drug." Additionally, the commercials suggested Yaz could be used to treat symptoms of Premenstrual Syndrome, a treatment which was not granted approval by the FDA. By broadening the usage of Yaz and underplaying its side effects, many women may have taken the drug under false pretenses.

The manufacturers have known about the risk of potential Yaz and Yasmin problems for some time and multiple studies have established the potential risk of life-threatening injuries.  Despite the known risks, the drug makers have continued to market Yasmin without adequate warnings and introduced Yaz, another oral contraceptive containing drospirenone, which also carries the same risks.

If you have experienced serious side effects outlined above caused by Yaz and Yasmin and wish to receive additional information about your legal options, please call 1-888-756-6494 or fill out the form on this page.

 

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