Just As It Did In 2010 Label Change, Bayer Contends New Medical Studies Are Less Reliable Than Other VTE Evidence
(Posted by Tom Lamb at DrugInjuryWatch.com)
UPDATE: New research suggests that women who use oral contraceptives (OCs) containing drospirenone (DRSP) have an increased risk of venous thromboembolism (VTE) compared with users of birth control pills containing levonorgestrel . These findings are from a Danish study published by the British medical journl BMJ online October 25, 2011:
Risk of venous thromboembolism from use of oral contraceptives containing different progestogens and oestrogen doses: Danish cohort study, 2001-2009. Lidegaard Ø, Nielsen LH, Skovlund CW, et al. BMJ 2011; DOI: 10.1136/bmj.d6423. Full text available for FREE at BMJ web site.
UPDATE: FDA Drug Safety Communication: Safety Review of possible increased risk of blood clots with birth control pills containing drospirenone [May 31, 2011]
... The European Medicines Agency (EMA) announced on May 27, 2011, that it is updating the product information on oral contraceptives containing drospirenone and ethinyl estradiol regarding the risk of venous thromboembolism after review of all available data, including the same newly published data FDA is reviewing.
The FDA is currently evaluating the conflicting results from these studies and will look at all currently available information to fully assess the risks and benefits of drospirenone-containing birth control pills. FDA will continue to communicate any new safety information to the public as it becomes available.
Women who use Bayer's YAZ and Yasmin birth control pills -- or other oral contraceptives containing the progesterone, or progestin, drospirenone (DRSP), e.g., Ocella, Gianvi, Zarah, Beyaz, and Safyral -- face a two-times to three-times higher risk for venous thromboembolism (VTE), or blood clots, than women using birth control products containing levonorgestrel, according to two case-control analyses published by The British Medical Journal (commonly called "BMJ") in April 2011.
As for Bayer's response to these two new BMJ articles about the safety of YAZ and Yasmin, it was more or less the same as the press release it issued back in April 2010 when Bayer refuted the reliability of two earlier BMJ articles which asserted that women using birth control pills with drospirenone, like YAZ and Yasmin, were at an increased risk of developing blood clot-related side effects such as pulmonary embolism (PE) or deep vein thrombosis (DVT).
The two BMJ articles in published in 2011 about DRSP birth control pills like YAZ and Yasmin are:
"Risk of venous thromboembolism in users of oral contraceptives containing drospirenone or levonorgestrel: nested case-control study based on UK General Practice Research Database"; and,
"Risk of non-fatal venous thromboembolism in women using oral contraceptives containing drospirenone compared with women using oral contraceptives containing levonorgestrel: case-control study using United States claims data".
The earlier 2009 BMJ articles about two studies that Bayer characterizes as "unreliable" in its current package insert, or label, for YAZ and Yasmin (accessed 4/25/11) are:
"Hormonal contraception and risk of venous thromboembolism: national follow-up study"; and,
"The venous thrombotic risk of oral contraceptives, effects of oestrogen dose and progestogen type: results of the MEGA case-control study".
The corresponding press releases issued by Bayer about these two sets of YAZ / Yasmin drug safety articles published by BMJ, which were issued almost exactly a year apart (but are virtually the same as far as their "tune" goes), are:
"Bayer Affirms Benefit-Risk Profile of Its Oral Contraceptives -- Established body of well grounded data show VTE risk comparable in combined oral contraceptives studied" (April 22, 2011); and,
"BAYER UPDATES LABELS FOR YAZ and YASMIN -- Body of Evidence Affirms VTE Risk/Benefit Profile for YAZ and Yasmin Is Comparable to Other Combination Oral Contraceptives" (April 9, 2010).
In fact, one wonders whether the March 2011 label change for YAZ which we wrote about here -- "Another Rather "Odd" YAZ Label Change By Bayer: March 2011 -- Provides New Warnings About Certain Side Effects As Regards ALL Birth Control Pills (Not Specific To YAZ)" -- was not made by Bayer in anticipation of more medical journal articles with findings about the increased blood clot risks, like those recently published by BMJ.
To summarize, several different medical researchers find a significant increased risk of developing blood clots when using YAZ or Yasmin and the medical journal BMJ accepts their articles for publication, but Bayer tells everyone to just ignore those findings because their safety evidence is better.
Hopefully the FDA will not follow Bayer's advice and, instead, take action based on these two sets of medical articles about the blood clot side effects linked to YAZ and Yasmin, as well as Ocella, Gianvi, Zarah, Beyaz, and Safyral -- birth control pills which contain the progestin drospirenone, or DRSP.
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