Parker Waichman LLP Injury Alerts
Yaz, Yasmine, and Ocella Present Women with Little More than a Potentially Deadly Game of Russian RouletteFeb 1, 2010
The popular oral contraceptive Yaz and its stronger version, Yasmin (and its generic version, Ocella) have been linked to serious adverse reactions and side effects as well as an alarming number of deaths. Complications associated with the drugs include heart attack, cardiac arrhythmia, stroke, hyperkalemia (see below), pulmonary embolism, deep vein thrombosis and other types of dangerous and unexpected blood clotting, gallbladder disease, and a number of other serious medical problems.
While these drugs are primarily used to prevent pregnancy, they have also been approved to treat premenstrual dysphoric disorder (PMDD) and moderate acne. Touting these added “benefits,” Bayer Pharmaceuticals has aggressively marketed Yaz through Direct to Consumer Advertising (DTCA) as a birth control option that improves a woman’s quality of life. As a result, Yaz has become one of the most prescribed contraceptives on the market. Despite Bayer’s cheerful ads, Yaz contains a dangerous hormone combination that puts otherwise healthy young women at risk of serious injury and death. According to the Food and Drug Administration (FDA), there were at least 50 deaths in the United States associated with Yaz/Yasmin between 2004 and 2008.
Yaz’s Progestin Hormone Poses a High Risk of Dangerous Clotting
The active ingredients in Yaz are a combination of the hormones drospirenone and ethinyl estradiol. Drospirenone, a synthetic progestin hormone, can raise blood potassium levels, causing hyperkalemia. Hyperkalemia disrupts normal heart rhythms, causing the flow of blood through the heart to slow to a point that permits blood clots to form in the body.
Blood clots typically form in veins and, since veins return blood to the heart, a clot (or a piece of one) can be carried through the right side of the heart and into the lungs. A blood clot in the lungs is known as a pulmonary embolism. Clots that form in the deep veins in the legs are known as deep vein thrombosis (DVT) and can cause extreme pain. Blood clots can also cause heart attacks and strokes. In otherwise healthy women these blood clots are often overlooked or misdiagnosed as they are difficult to pinpoint.
Symptoms of blood clots include:
- Sudden severe headaches
- Sharp chest pains
- Coughing up blood
- Swelling or pain in the legs or arms
- Pain in the back of the lower leg
- Blurred or double vision, complete loss of vision
Even if diagnosed and treated, blood can cause long-term lasting effects requiring a lifetime of medications to prevent the formation of more clots. Yaz can also cause serious gallbladder problems that may require a cholecystectomy (gallbladder removal).
Symptoms of gallbladder problems include :
- Pain or discomfort in the upper right side of the abdomen
- Abdominal Bloating
- Jaundice (yellowing of skin, eyes)
A High-Risk Hormone Hyped in Misleading DTCA Advertisements
Birth control pills prevent pregnancy by altering a woman’s hormones. Researchers have long known that taking a combination hormone birth control pill (one which contains estrogen and a progestin hormone) can increase the risk of stroke and blood clots in the legs and lungs. Since estrogen was found to play a role in blood coagulation, drug companies have greatly reduced estrogen doses to decrease the risk of thrombosis (blood clots).
The ongoing safety debate has recently focused on how synthetic progestins affect the risk of cardiovascular problems. Recent studies on the safety of birth control pills have reported on the varying risks of different progestins. Yaz causes a greater-than-usual number of blood clots compared to older contraceptives because of its new progesterone ingredient, drospirenone. According to a study conducted by the British Medical Journal (BMJ), users of contraceptives containing drospirenone were 6.3 times more likely to develop venous thrombosis than those taking contraceptives with a different progesterone ingredient.
The FDA approved Yasmin in 2001. Yaz, which also contains drospirenone but with a lower dose of estrogen than Yasmin, was approved in 2006 as a contraceptive with the added benefits of treating moderate acne and premenstrual dysphoric disorder (PMDD), a severe form of premenstrual syndrome (PMS) associated with debilitating emotional and physical symptoms. There can be no real doubt that the drug’s popularity is the result of due in large part to a multimillion-dollar advertising campaigns that depict Yaz and Yasmine as promoting a higher quality of life along with contraception. In 2008 alone the two drugs brought in about $1.8 billion in worldwide sales.
Bayer is now involved in extensive litigation brought by women who have been injured after taking Yasmin or Yaz as well as by the estates of women who have died as a result of complications caused by the drugs, which already carry warnings that the possible potassium increase may put women with liver and kidney problems at higher risk for serious health problems. Bayer maintains that since their labels contain a warning about the risks associated with their drugs, they should not be liable for putting a dangerous drug on the market. However, Bayer has been issued several warnings directly from the FDA regarding their misleading and untruthful marketing campaigns and has had to clarify those ads at the direction of the FDA.
Yaz ads severely downplayed the serious side effects known to come with its hormone combination, while falsely positioning it as a cure for PMS and acne. This positive, yet highly inaccurate portrayal of the drug enticed many unsuspecting women to take the pills thereby exposing them to health risks that they would not have otherwise encountered.
Multiple Warnings From the FDA
In October 2008, the FDA issued a warning to Bayer for running two openly false and misleading Yaz television advertisements. The ads in question overstated Yaz's efficacy, promoted it for treating PMS (it is only approved for PMDD, not PMS), and downplayed the serious risks associated with the drug. In February 2009, Bayer agreed to spend $20 million on a corrective ad campaign to address these inaccuracies.
The FDA again warned Bayer in August 2009, regarding deviations from quality control standards at a German manufacturing plant that produces the drospirenone used in pills sold in the U.S. Methods used by the facility to calculate variability in ingredients did not meet U.S. standards. According to the FDA warning letter, Bayer used a testing method that averaged the test results rather than reporting the test results for individual batches. The average met the specified parameters, but some individual batches were out-of-specification, and should never have been shipped. At least eight batches that were improperly tested were shipped to the U.S. containing levels of the risky hormone that did not comply with U.S. safety standards.
Upon reviewing batches shipped to the U.S. between 2007 and 2009, Bayer responded to the FDA in April, 2009, claiming they found no problem with the quality. The FDA pushed back once again, saying Bayer’s response did not adequately address some of the deficiencies they had outlined.
Bayer is now required to give the FDA a list of all the batches shipped to the U.S. that may have been tested with the unacceptable method. The FDA may also delay imports from the plant.
Michael Santoro, an associate professor at Rutgers Business School who has studied ethics in the drug industry, said these warnings from the FDA about advertising and quality control do not shine a favorable light on Bayer's approach to complying with government guidelines.
An FDA spokesperson said the agency is currently reviewing the safety of oral contraceptives through a study designed to identify the incidence of blood clots, stroke and death among users of Yasmin and other oral contraceptives. Bayer also is conducting a post-market study comparing Yaz's safety with that of other oral contraceptives.
Legal Assistance Available
On October 1, 2009, all Yaz and Yasmin lawsuits pending in federal court were consolidated for centralized and coordinated pre-trial proceedings. On November 10, 2009, A partner at Parker Waichman LLP, was appointed to the Plaintiffs’ Steering Committee in the Multi District Litigation (MDL) involving these three dangerous drugs.
If you or a loved one has taken Yaz, Yasmin, or Ocella, and suffered from serious side effects including deep vein thrombosis, pulmonary embolism, stroke, heart attack, or hyperkalemia, as a result of taking the drug, you have valuable legal rights. Please visit www.yourlawyer.com, or call 1-800-YOURLAWYER (1-800-968-7529) to discuss your case with one of our Yaz injury lawyers.