Safety Study Findings About Drospirenone (DRSP) Birth Control Pills Will Be On The Agenda For FDA Advisory Committees At Joint Meeting In December 2011
(Posted by Tom Lamb at DrugInjuryWatch.com)
On October 27, 2011 the FDA released its new drug-safety study report, "Combined Hormonal Contraceptives (CHCs) and the Risk of Cardiovascular Disease Endpoints", which included the popular birth control pills YAZ, Yasmin, and Ocella.
This FDA study was intended to determine whether drospirenone (DRSP)-containing oral contraceptives like YAZ, Yasmin, Ocella, etc. -- as well as some other relatively new birth control products, namely the Ortho Evra patch and the NuvaRing vaginal ring -- were associated with an increased risk of cardiovascular side effects such as:
•Venous thromboembolic events (VTE), including deep venous / vein thrombosis (DVT) and pulmonary embolism (PE); and,
•Arterial thrombotic events (ATE), including heart attack / acute myocardial infarction (AMI), and ischemic stroke.
Drospirenone (DRSP) is in the oral contraceptive pills Beyaz, Gianvi, Loryna, Ocella, Safyral, Syeda, Yasmin, Yaz, and Zarah.
In relevant part, this new FDA study found that all of the DRSP-containing oral contraceptives were associated with a significantly higher risk of deep vein thrombosis (DVT) and pulmonary embolism (PE) relative to standard low-dose estrogen birth control pills, with the estimate of relative risk for these DRSP birth control pills being 1.74 (95% CI 1.42 to 2.14).
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Some of the key points made in this October 2011 FDA study report about DRSP birth control pills:
- For the analysis restricted to new users, only DRSP was associated with a significantly higher risk of both ischemic stroke and heart attack (with this finding restricted to women in the 35-55 years age group only) -- relative risk: 2.01 (95% CI 1.06 to 3.81) -- as well as deep vein thrombosis (DVT) and pulmonary embolism (PE) (associated with DRSP use was in the 10-34 years age group) -- relative risk: 1.77 (95% CI 1.33 to 2.35).
- Findings suggest that there may be an increase in risk of deep vein thrombosis (DVT) and pulmonary embolism (PE) with DRSP during the early stages of new use relative to the risk from standard low-dose estrogen birth control pills as well as later in time. In more detail, DRSP was associated with significantly higher risk of DVT and PE when used for less than 3 months -- relative risk: 1.93 (95% CI 1.24 to 3.00)] -- as well as during the period of time 6 to 12 months after initial use -- relative risk: 2.80 (95% CI 1.48 to 5.29).
- DRSP may increase cardiac arrhythmia risks and sudden deaths among users because it has anti-mineralocorticoid activity that may increase potassium levels.
Here are the reasons this FDA birth control safety study, which includes YAZ, Yasmin, and Ocella, was done:
The objective of the FDA-funded study was to assess cardiovascular risks, including the risk of thrombotic and thromboembolic events and death, for several newly approved (early 2000s) products that had sufficient numbers of users to allow for an evaluation of these risks compared to those associated with use of older, more frequently prescribed contraceptives at the sites selected. If an increased risk was observed, the FDA-funded study would subsequently attempt to assess user characteristics and prescribing patterns that might help explain the increased risk. It was recognized at the time that a more in-depth assessment of potential reasons for increased risk would not be possible using only claims and electronic medical records and would require physician and patient contact, something that could be conducted later if needed. [emphasis added]
The FDA said these new study findings about YAZ / Yasmin / Ocella side effects -- like PE and DVT, as well as strokes and heart attacks -- 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 December 8, 2011 in the Washington, DC area.
Of course, we are anxious to hear the discussions about YAZ, Yasmin, Ocella, etc. at the FDA advisory committees meeting and, later, will be watching for any continuation of this FDA DRSP birth control pills safety study -- as the agency's explanation of its reasons for this birth control study, above, suggests is a possibility.
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