Given These New FDA Drug Safety Findings About Ortho Evra, What Will Two Advisory Committees Do At Joint Meeting On December 9, 2011?
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 Ortho Evra birth control skin patch (norelgestromin/ethinyl estradiol transdermal patch) -- referred to as "NGMN" in this 2011 FDA study report.
This FDA study was intended to determine whether the Ortho Evra patch -- as well as some other relatively new birth control products, namely the drospirenone (DRSP)-containing oral contraceptives like YAZ, Yasmin, Ocella, etc. 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.
In relevant part, this new FDA study found that the Ortho Evra patch was 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 1.55 (95% CI 1.17 to 2.07).
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Some of the key points made in this October 2011 FDA study report about the Ortho Evra birth control patch:
- The Ortho Evra patch was associated with significantly higher risk for developing deep vein thrombosis (DVT) and pulmonary embolism (PE) when used for more than 12 months -- relative risk: 3.05 (95% CI 1.23 to 7.53). This is a remarkable 3-fold increase in risk of VTE relative to when standard low-dose estrogen birth control pills were used for more than 12 months.
- Continuous exposure Combined Hormonal Contraceptives (CHCs) such as the Ortho Evara patch potentially result in higher sustained exposure to estrogen and hence, increased thromboembolic risk.
- The positive finding for the Ortho Evra patch in relation to VTE such as DVT and PE provides an additional piece of evidence that this is a causal association.
Here are the reasons this FDA birth control safety study, which includes the Ortho Evra skin patch, 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]
It seems highly probable that these October 2011 FDA study findings about Ortho Evra side effects such as deep vein thrombosis (DVT) and pulmonary embolism (PE) will be presented by the FDA to its Reproductive Health Drugs and Drug Safety and Risk Management advisory committees at a joint meeting which will take place December 9, 2011 in the Washington, DC area.
Of course, we are anxious to hear the discussions about Ortho Evra at the FDA advisory committees meeting and, later, will be watching for any continuation of this FDA Ortho Evra safety study -- as the agency's explanation of its reasons for this birth control study, above, suggests is a possibility.
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