New Medical Journal Article Presents "Compelling Evidence" That These Newer Oral Contraceptives Are Associated With More Venous Thromboembolism Events
Beyaz, Safyral, YAZ, and Yasmin are birth control pills which contain ethinyl estradiol (EE) and the progestin drospirenone (DRSP). These DRSP oral contraceptives have been associated with several different adverse side effects such as:
- Blood Clots
- Deep Vein Thrombosis (DVT)
- Pulmonary Embolism (PE)
- Stroke or Cerebrovascular Accidents (CVA)
- Heart Attack or Myocardial Infarction
From an Editorial piece published May 26, 2015 by the medical journal BMJ, "Fresh evidence confirms links between newer contraceptive pills and higher risk of venous thromboembolism", we get this commentary from Susan S. Jick (a professor of epidemiology at Boston Collaborative Drug Surveillance Program, Boston University School of Public Health):
Notably, Vinogradova and colleagues also looked at the newer oral contraceptives, such as those containing desogestrel, gestodene, and cyproterone, as well as the newest pill containing drospirenone, where data have been limited and the magnitude of effects on the risks of venous thromboembolism remains controversial. They found that the newer contraceptives increased risks by around 3.6- to 4.3-fold compared with non-use, and by around twofold compared with oral contraceptives containing levonorgestrel, norethisterone, or norgestimate. Combined, the results provide compelling evidence that these newer oral contraceptives are associated with a higher risk of venous thromboembolism than older options, despite attempts to develop safer hormonal contraceptives for women.
The important new medical study that Dr. Jick is alluding to above is the subject of this article, "Use of combined oral contraceptives and risk of venous thromboembolism: nested case-control studies using the QResearch and CPRD databases", published in the same edition of the BMJ medical journal. The lead researcher is Yana Vinogradova ( research fellow in medical statistics at Division of Primary Care, University Park, Nottingham, UK).
From the Abstract for this May 2015 medical journal article:
Objective To investigate the association between use of combined oral contraceptives and risk of venous thromboembolism, taking the type of progestogen into account.
Results 5062 cases of venous thromboembolism from [two nested case-control studies] were analysed. Current exposure to any combined oral contraceptive was associated with an increased risk of venous thromboembolism (adjusted odds ratio 2.97, 95% confidence interval 2.78 to 3.17) compared with no exposure in the previous year. Corresponding risks associated with current exposure to desogestrel (4.28, 3.66 to 5.01), gestodene (3.64, 3.00 to 4.43), drospirenone (4.12, 3.43 to 4.96), and cyproterone (4.27, 3.57 to 5.11) were significantly higher than those for second generation contraceptives levonorgestrel (2.38, 2.18 to 2.59) and norethisterone (2.56, 2.15 to 3.06), and for norgestimate (2.53, 2.17 to 2.96). The number of extra cases of venous thromboembolism per year per 10 000 treated women was lowest for levonorgestrel (6, 95% confidence interval 5 to 7) and norgestimate (6, 5 to 8), and highest for desogestrel (14, 11 to 17) and cyproterone (14, 11 to 17).
Conclusions In these population based, case-control studies using two large primary care databases, risks of venous thromboembolism associated with combined oral contraceptives were, with the exception of norgestimate, higher for newer drug preparations than for second generation drugs.
In order to put this new birth control pill study into context as regards the relative safety of Beyaz, Safyral, YAZ, and Yasmin in terms of blood clot side effects like DVTs and/or PEs, we return to the May 2015 BMJ Editorial piece by Dr. Jick:
There is controversy surrounding the association between different oral contraceptives and risk of venous thromboembolism, which is due to the variability of case definition and inclusion criteria, and has led to divergent results. Vinogradova and colleagues tried to address differences within previous study designs to help explain the range of results....
Vinogradova’s comprehensive study addresses important questions about the risk of venous thromboembolism in women taking oral contraceptives, concluding that the risk associated with newer pills is around twofold higher than the risk associated with older contraceptives. The risk varies according to case definition of venous thromboembolism, and does not seem to be materially higher for new users of oral contraceptives. These results, combined with those published in a similar study by Lidegaard and colleagues, clarify inconsistencies in earlier studies and provide important guidance for the safe prescribing of oral contraceptives.
[Emphasis added; Footnotes omitted]
Moving from the medical realm to the legal arena, from the PRODUCT-RELATED LITIGATION part of Bayer's Annual Report 2014 (at pg. 311 of the PDF document):
Yasmin™ / yaz™: As of January 31, 2015, the number of claimants in the pending lawsuits and claims in the United States totaled about 5,000 (excluding claims already settled). Claimants allege that they have suffered personal injuries, some of them fatal, from the use of Bayer’s drospirenone-containing oral contraceptive products such as Yasmin™ and / or yaz™....
As of January 31, 2015, Bayer had reached agreements, without admission of liability, to settle approximately 9,500 claims in the U.S. for venous clot injuries (deep vein thrombosis or pulmonary embolism) for a total amount of about US$1.9 billion. Bayer will continue to consider the option of settling such claims after a case-specific analysis of medical records. At present, about 2,000 such claims are under review....
Additional lawsuits are anticipated....
We will continue to watch for legal, medical, and regulatory developments as regards Beyaz, Safyral, YAZ, and Yasmin, as well as other DRSP birth control pills such as Gianvi and Ocella.