Yasmin

Fill out a YAZ / Yasmin / Ocella claim evaluation.

Purpose / History

YAZ/Yasmin/Ocella is advertised as an oral contraceptive (birth control pill) prescribed for the prevention of pregnancy. It has also been advertised for the treatment of the emotional and physical symptoms of premenstrual dysphoric disorder (PMDD) as well as treatment of moderate acne vulgaris. Promises were made that YAZ would treat “headaches, feeling anxious, fatigue, bloating, increased appetite, muscle aches and moodiness” in addition to the prevention of pregnancy.

YAZ, Yasmin and Ocella (generic of Yasmin) are the only oral contraceptives sold in the United States that contain the progestin, drospirenone and ethinyl estradoil.

YAZ, Yasmin and Ocella are called combination hormone contraceptives because of the combination of estrogen and the progestin, drospirenone. The progestin drospirenone is also a diuretic. Drospirenone is a hormone which promotes dehydration; however, the loss of fluid in the body increases the chances of blood clots being formed in the blood. Further, studies have shown that long term use of diuretics like drospirenone can cause serious gallbladder problems. In some cases, surgery is required to remove the gallbladder completely. The manufacturer did not provide a warning which specifically indicated adverse effects involving the gallbladder.

The difference between YAZ and Yasmin (and Ocella, the generic version of Yasmin) is the amount of estrogen each contains – YAZ has a lower dose than the older drug, Yasmin and its generic equivalent, Ocella, but all three contain the dangerous progestin, drospirenone.

A report from British Medical Journal, published September 11, 2009, stated that the progestin, drospirenone increased 6.3 fold involving incidents of Deep Vein Thrombosis (DVT) or pulmonary embolism. In addition to the dangers of blood clots, drospirenone is also well known for increasing the risk of Hyperkalimia by increasing the body’s uptake of potassium.

YAZ, Yasmin and Ocella can produce severe side effects, more so than the more traditional oral contraceptives. These include incidents of:

Severe side effects:

• Deep Vein Thrombosis
• Pulmonary Embolism
• Thrombophlebitis
• Arterial Thromboembolism
• Cerebral Hemorrhage
• Cerebral Thrombosis
• Hypertension
• Gallbladder Disease
• Hepatic adenomas or benign liver tumors
• Hyperkalimia
• Stroke
• Heart Attack
• Kidney Failure
• Renal Failure

Additional side effects are:

• Nausea
• Vomiting
• Migraine
• Mood changes, including depression
• Change in corneal curvature, intolerance to contact lenses
• Aggravation of varicose veins
• Colitis
• Acne
• Loss of scalp hair
• Pancreatitis
• Upper respiratory infection
• Abdominal pain
• Weight gain
• Urinary tract infection

Legal Status

In August 2009, the FDA required the manufacturer of YAZ, Yasmin and Ocella to place a “Black Box Warning” on the packaging advising that women who have kidney, liver or adrenal disease not take the drug. The warning further stated that women taking chronic inflammatory or particular cardiovascular drugs that may also increase potassium should have their potassium level checked within the first month of taking YAZ, Yasmin or Ocella.

Reports of over 50 deaths among users of YAZ, Yasmin and Ocella were reported to the U.S. Food and Drug Administration. The causes of death include cardiac arrhythmia, intracardiac thrombus [blood clots in the heart], pulmonary embolism [blood clot in the lungs], and stroke.

Hundreds of lawsuits have been filed against Bayer in the United States. The most recent lawsuits include false representation that the product was tested and found to be safe by the Food and Drug Administration. In October of 2009, the lawsuits pending in the federal court were consolidated for centralizing and an MDL (Multi District Litigation) has been formed in the U.S. District Court for the Southern District of Illinois – MDL#2100.

MDL is a procedure utilized in the federal court system to transfer to one federal judge all pending civil cases of a similar type filed throughout the United States. The decision of whether cases should be transferred is made by a panel of seven federal judges appointed by the Chief Justice of the United States Supreme Court. If the review is favorable, an MDL is formed in an effort to streamline the mechanics of the civil trial process.

YAZ / Yasmin / Ocella Claim Evaluation

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