Researchers Find Drospirenone (DRSP) Containing Birth Control Pills Increased Risk Of Pulmonary Embolism (PE) And Deep Vein Thrombosis (DVT)
(Posted by Tom Lamb at DrugInjuryWatch.com)
New research published online in October 2011 by the BMJ medical journal and in November 2011 by the Canadian Medical Association Journal (CMAJ) indicates that women who use oral contraceptives (OCs) containing drospirenone (DRSP) have an increased risk of venous thromboembolism (VTE) such as pulmonary embolism (PE) or deep vein thrombosis (DVT) compared with users of older birth control pills containing second-generation or third-generation progestins.
Here are some background points intended to provide some context to the findings of these 2011 medical journal articles concerning drospirenone (DRSP):
- The contraceptive pills Beyaz, Gianvi, Loryna, Ocella, Safyral, Syeda, Yasmin, YAZ, and Zarah contain drospirenone, which is considered to be a fourth-generation progestin (also known as progesterone).
- The second-generation class of progestins includes levonorgestrel and norgestrel.
- The third-generation class of progestins includes desogestrel, gestodene, and norgestimate.
We will start with the October 2011 BMJ article, "Risk of venous thromboembolism from use of oral contraceptives containing different progestogens and oestrogen doses: Danish cohort study, 2001-2009."
This Danish study found that birth control pills like YAZ, Yasmin, or Ocella which contain drospirenone (DRSP) or oral contraceptives (OCs) containing a third-generation progestins put women at two-times the risk of developing venous thromboembolism (VTE) -- possibly leading to blood clot side effects like PE or DVT -- when compared to women who used birth control pills with levonorgestrel, a second-generation progestin.
YAZ / Yasmin / Ocella / Beyaz / Safyral
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In more detail, when compared to levonorgestrel-containing pills and with the rate ratios of confirmed venous thromboembolism (VTE) adjusted for length of use, the increased risks were:
• 2.2 with desogestrel (95% CI 1.7 to 3.0)
• 2.1 with gestodene (95% CI 1.6 to 2.8)
• 2.1 with drospirenone (95% CI 1.6 to 2.8)
As for the significance of these new findings, we provide these observations from an October 26, 2011 news article, "Higher VTE risk with newer progesterone oral contraceptives", published by theheart.org:
Commenting on the study, Dr Susan Jick (Boston University School of Medicine, MA) said, "There is controversy over whether third-generation OCs and drospirenone OCs increase the risk of VTE more than second-generation OCs such as the levonorgestrel-containing OC. This study supports the research that suggests that these OCs do carry a higher risk of VTE compared with the levonorgestrel OC.
"All things being equal, I would not prescribe a third-generation OC or a drospirenone OC, given the higher VTE risk."
In accompanying editorial ["The progestogen content of combined oral contraceptives and venous thromboembolic risk."], Dr Philip C Hannaford (University of Aberdeen, Scotland) notes that the current study has attempted to address methodological problems with previous studies.
"Although unpalatable to some, it is difficult not to conclude that combined oral contraceptives with desogestrel, gestodene, or drospirenone confer a higher risk of venous thromboembolism than those with levonorgestrel. Many clinicians will choose to minimize the risk by prescribing a combined oral contraceptive with levonorgestrel whenever possible," he said.
Next, we move to the November 2011 CMAJ article, "Higher risk of venous thrombosis associated with drospirenone-containing oral contraceptives: a population-based cohort study", which assessed whether the use of DRSP-containing birth control pills like YAZ, Yasmin, and Ocella were "associated with an increase in thrombotic risk" when compared to the use of third generation oral contraceptives.
From the Asbtract for this CMAJ medical journal article:
Interpretation: Use of drospirenone-containing oral contraceptives was associated with an increased risk of deep vein thrombosis and pulmonary embolism, but not transient ischemic attack or cerebrovascular attack, relative to second- and third-generation combined oral contraceptives.
Accordingly, this second study further implicates the DRSP-containing oral contraceptives such as YAZ, Yasmin, and Ocella as being relatively unsafe when compared to older birth control pills.
To learn what the FDA is currently doing about this drug safety issue you can take a look at this recent Drug Injury Watch article: YAZ / Yasmin / Ocella Update: October 2011 FDA Study Finds Increased Risk Of Blood Clot Side Effects Like DVT, PE, Stroke, And Heart Attack.
The FDA has said that the findings from this October 2011 FDA study will be presented by the agency to its Reproductive Health Drugs and Drug Safety and Risk Management advisory committees at a joint meeting which will take place on December 8, 2011 in the Washington, DC area.
One supposes that the October BMJ article and the November CMAJ article, above, will be discussed at this FDA Advisory Committees meeting in December 2011, also.
Of course, we will let you know what happens at this December FDA meeting about the safety of DRSP birth control pills like YAZ, Yasmin, and Ocella.
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