Tuesday, November 24, 2009

Yaz, Yasmin, and Ocella Birth Control Drug Gallbladder & Death Lawsuits

Birth Control Medication  Lawsuits (Yaz, Yasmin, and Ocella Birth Control Drug Lawsuits)
YAZ, Ocella, and Yasmin are oral contraceptives that produced over $1 Billion in sales in the United States and $1.8 Billion worldwide in 2008.  These birth control pills are oral contraceptives that have been heavily marketed by Bayer HealthCare Pharmaceuticals, Inc., however, the FDA has found that past marketing campaigns were misleading as it minimized the potential health risks that have been associated with these oral contraceptives.  These health risks include sudden death, cardiovascular problems, blood clots, heart attacks, stokes, and gallbladder disease. 

Yaz, Yasmin, and Ocella Birth Control Medications Contain Drospirenone (DRSP) that has been Associated with Serious Health Risks

YAZ and Yasmin are combined oral contraceptive (COC) pills that contain ethinylestradiol (EE) and drospirenone (DRSP). These birth control medications are manufactured by Bayer HealthCare Pharmaceuticals, Inc., while Ocella is the generic equivalent of Yasmin that is manufactured by Barr Laboratories. Each of these birth control medications contain ethinyl estradiol and the new "fourth generation" progestin drospirenone (DRSP). Drospirenone is known for increasing the risk for hyperkalemia and these DRSP oral contraceptives have been associated with adverse health effects such as Death, Deep Vein Thrombosis (DVT), Pulmonary Embolism (PE), Strokes, Heart Attacks, Gallbladder Disease, and other health problems.

YAZ Marketing Campaign Created Annual Revenues of over $600 Million, but Overstated Drug Benefits and Understated Drug Dangers

The FDA has found that Bayer's marketing campaign that was directed at young women for the birth control drug, YAZ, was misleading. The misleading marketing campaign allowed YAZ to become the best-selling oral contraception pill in the United States with annual sales revenue of over $600 million in 2008, but understated the birth control medications' health risks.

Through the efforts of the FDA and several states' Attorney Generals, the manufacturer and marketer of the oral contraceptive YAZ was required to run a $20 million advertising campaign for the purpose of correcting previous YAZ marketing statements and will be required to submit all future YAZ ads for the next six (6) years to the FDA for screening.
The YAZ ads allegedly overstated the pill's ability to improve women’s moods and clear up acne, while not fully warning of the drug's potential serious side effect health risks including Death, Deep Vein Thrombosis (DVT), Pulmonary Embolism (PE), Strokes, Heart Attacks, Gallbladder Disease, and other health problems.

Recent FDA and Attorney Generals Take Action to Correct the YAZ Marketing Campaign Making Sure Bayer Does Not Understate Drug Dangers and Risks

In October 2008, the FDA took action against Bayer sending a warning letter to Bayer saying that two television ads overstated the drug’s benefits while understating its risks. The FDA warning letter stated that two 60 second direct to consumer broadcast television advertisements entitled "Not Gonna Take it" and "Balloons" submitted by Bayer HealthCare Pharmaceuticals, Inc. were "misleading because they broaden the drug's indication, overstate the efficacy of YAZ, and minimize serious risks associated with the use of the drug". Further, that these televisions advertisements "misbrand the drug in violation of the Federal Food, Drug, and Cosmetic Act".

The FDA had approved YAZ as a birth control pill that has a side benefit in treating a very specific mood-related psychological problem called "premenstrual dysphoric disorder" and improving moderate acne, however, Bayer overstated the drug's efficacy and minimized its potential dangers.

FDA Action against Yasmin for Minimizing Health Risks in 2003 Suggests Bayer May Have Had Prior Knowledge of Misleading Marketing that Minimized YAZ Health Risks

The contraceptive medication, YAZ, closely resembles another birth control medication, Yasmin. Both drugs contain contain ethinyl estradiol and the "fourth generation" progestin drospirenone (DRSP). Yasmin has been the subject of a similar FDA warning letter in 2003 that warned the manufacturer and marketer that their marketing advertisements were understating potential health risks and overstating the benefits of the birth control medication. At that time Yasmin was manufactured and marketed by Berlex Laboratories.

In 2006, Bayer HealthCare Pharmaceuticals, Inc. acquired Berlex Laboratories. Bayer now markets both oral contraceptives, YAZ and Yasmin which had sales of about $1.8 Billion in 2008.
Health Risks Related to the Oral Birth Control Mediations
Yaz, Yasmin, and Ocella

YAZ, Yasmin, and Ocella contain drospirenone (DRSP), a synthetic progestational compound that can cause serious side effects and has been associated with serious health problems including formation of dangerous blood clots, strokes, pulmonary embolisms (PE), gallbladder disease, deep vein thrombosis (DVT), heart attacks, and sudden death. Yaz and Yasmin are combined oral contraceptive (COC) pills that contain ethinylestradiol (EE) and drospirenone (DRSP). Both have been linked to blood clots and cardiovascular events as well as other serious health risks.

While it has long been known that taking a combined oral contraceptive (COC) pill with a combination of estrogen and a progestin hormone can increase the risk of stroke and blood clots in the legs and lungs, the health risks of newer synthetic should have been deceptively marketed as having less health risks with other benefits that the contraceptives do not have.
In October 2008, the Food and Drug Administration (FDA), concerned with the improper advertising of the YAZ/Yasmin/Ocella birth control drugs, issued a warning letter to the Bayer Corporation to cease unlawful promotion. Also, women who have taken these popular oral contraceptives reported serious side effects, including blood clots, stroke, gallbladder complications and heart attack as a result of taking the drugs.

It is thought that these birth control medications contain hormones the effect cholesterol metabolism and excretion into the gallbladder thereby affecting the cholesterol concentration and crystallization of bile acids in the secretions leading to gall stones as well as can lead to clots, strokes, or heart attacks.

For more information on YAZ/Yasmin/Ocella birth control drug Gallbladder Disease and Death Lawsuits, please go to the following YAZ Yasmin Ocella Lawsuit Website.