Medical Studies

Catchy Advertising Camouflages Dangers of Bayer Birth Control Drugs; Searcy Denney Attorneys Now Representing Women Who Have Been Harmed by Yaz

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Read More:

• Yaz, Yasmin and Ocella — New Studies Confirm Old Concerns
• What was Bayer thinking with “all that Yaz”?
• Drug Marketing Direct to Consumers
• Yaz Litigation in Mass Tort Coordination
• National Coordination of YAZ Litigation Requested
• The Show Must Go On and all that Yaz!

Numerous studies over the past ten years have confirmed the potentially lethal risks of YAZ, Yasmin, Ocella, and the six additional birth control drugs containing drospirenone. (All nine drugs are listed at the beginning of this web page, along with links to patient information and warning labels.) At least one large study is ongoing, geared to measuring both short-term and long-term cardiovascular risk.

• In July 2004, the International Society of Thrombosis and Haemostatis published a study sounding an alarm regarding new oral contraceptives in Europe that contained the progestins drospirenone (namely, Yasmin) and cyporoterone acetate. This study focused on identifying women who were at increased risk of developing blood clots by testing for their sensitivity relating to procoagulant, anticoagulant, and fibrinolytic parameters. The study found that women taking Yasmin were more resistant to their body’s anticoagulation activities than women taking third-generation birth control pills that contained desogestrel or gestodene. These scientists concluded that, even though more studies were needed, physicians should not prescribe Yasmin and birth control that contained drospirenone as a first oral contraceptive for girls and women.

• The August 13, 2009, edition of the British Medical Journal featured results of the MEGA population based, case-control study of premenopausal women in the Netherlands taking oral contraceptives, which included 1,524 patients and 1,760 controls. Results indicated that all currently available oral contraceptives increased the risk of venous thrombosis five-fold when compared with non-use. However, the extent of risk differed by type of progestin and the dosage of estrogen. According to this study, women using birth control containing drospirenone (such as YAZ, Yasmin and Ocella) face 6.3 times the risk (or a 630% increase) of developing blood clots, compared to non-users.

• A second study published in the August 13, 2009, British Medical Journal, authored by Dr. Ojvind Lidegaard and others, pointed to serious safety concerns over birth control pills that contain drospirenone. This study involved Danish women between ages 15 and 49 with no history of cardiovascular or malignant disease.

  The relative risk of suffering deep vein thrombosis (DVT), portal thrombosis, caval vein thrombosis, renal vein thrombosis, and pulmonary emboli was 6.2901 in women currently using oral contraceptives, or essentially a six-fold or 600% increased risk of suffering harm due to a blood clot. The lowest risk was associated with birth control products containing progestins norethisterone and norgestimate, while higher risks were noted with oral contraceptives that contained the progestins drospirenone, cyproterone, desogestrel, and gestodene.

  This Danish study was also noteworthy in that it pointed to elevated levels of sex hormone-binding globulin levels and activated protein C resistance in patients who were taking progestins associated with the greatest risk of developing blood clots – which may provide an explanation for the mechanism of injury to young women taking these drugs.

• BMC Medical Research Methodology published in November 2009 an update on a large ongoing study about the safety of YAZ that was begun in August 2005. The International Active Surveillance Study of Women Taking Oral Contraceptives (INAS-OC Study) was initiated to evaluate the cardiovascular risks for women who take YAZ and will eventually include 2,000 gynecologists and more than 80,000 women taking oral contraceptives in Austria, Germany, Italy, Poland, and Sweden. However, this is not an independent project, as it is reportedly funded by a grant from Bayer.

• According to an article published in the April 21, 2011, edition of the British Medical Journal, findings of a nested case-control study in the United Kingdom “contribute to emerging evidence that the combined oral contraceptive containing drospirenone carries a higher risk of venous thromboembolism than do formulations containing levonorgestrel” (a second generation progestin contained in some other oral contraceptives such as Seasonale, Seasonique, and Lybrel).

  In a subsequent defense of their study, the authors concluded:

  Finally, the fundamental issue is the need to optimize the benefit to risk profile of drugs. Out studies contribute to emerging evidence that drospirenone oral contraceptives carry a higher risk of VTE than levonorgestrel pill, while systematic reviews have found no convincing evidence that drospirenone confers benefits over and above those of other pills.

  In order to evaluate the risks of non-fatal blood clots in women using oral contraceptives containing drospirenone versus levonorgestrel, Drs. Jick and Hernandez analyzed insurance claims data and billing codes obtained from health insurers in the United States. The study focused on use of these birth control pills between 2002 and 2008, excluding women who had been diagnosed with other conditions that would put them at risk of venous thromboembolic events such as cancer, renal failure, chronic cardiovascular disease, autoimmune diseases, severe lower limb injury, recent major surgery, pregnancy, or severe trauma.

  Researchers noted that women using birth control containing drospirenone were more than two times more likely to have suffered a deep vein thrombosis or pulmonary embolism attributable to the drugs than women who used products that contain levonorgestrel. These findings are consistent with two previous studies published in the British Medical Journal in 2009, which also indicated far greater risk of blood clot events in women who used YAZ, Yasmin, and Ocella.

  The authors also noted that “findings support more recent studies that suggest that drospirenone oral contraceptives are not as safe as levonorgestrel oral contraceptives with respect to venous thromboembolism and, in the absence of other considerations, should not be the first choice in oral contraception.

• A study published April 18, 2011, in the Canadian Medical Association Journal, drew upon a health insurer database with information on 2.5 million women who had used birth control pills for at least six months. The study excluded women with risk factors for gallbladder disease, including sickle-cell anemia, diabetes, inflammatory bowel disease, obesity, pancreatitis, smoking, and use of certain cholesterol medications.

  This study found a 39% increase in the incidence of gallbladder disease in patients using birth control containing drospirenone for more than six months. Although the authors call this a “small, statistically significant” increase in risk and cite some limitations in the reliability of their data, this study is significant because previous evidence of links between increased risk of gallbladder disease and birth control pills has been anecdotal or from adverse event databases.