Approved By FDA In 2010, There Has Been No Study Done Yet Regarding Beyaz Safety -- Despite Significant Number Of Beyaz Adverse Event Reports
UPDATE: FDA Meeting Materials for Pediatric Focused Safety Review: Beyaz (ethinyl estradiol, drospirenone, levomefolate calcium) Pediatric Advisory Committee Meeting September 11, 2012 (PowerPoint PDF)
On August 31, 2012 the FDA made available their "Briefing Materials for the September 11, 2012 Meeting of the Pediatric Advisory Committee", which included a "Beyaz Safety Review" (PDF) that was prepared by some FDA staff members.
In more detail, from that FDA Beyaz report, we get this contextual information:
Review of Postmarketing Adverse Event Reports to FDA
In accordance with the Pediatric Research Equity Act (PREA), the Division of Pharmacovigilance (DPV 1) was asked to summarize post-marketing reports of adverse events associated with the use of Beyaz [ethinyl estradiol (EE), drospirenone (DRSP), levomefolate calcium] in pediatric patients (0-17 years of age). The main focus of the pharmacovigilance review was to evaluate pediatric deaths and pediatric reports of serious unlabeled adverse events with Beyaz.
Beyaz, which was approved by the FDA in September 2010, is the first combination oral contraceptive (COC) to contain levomefolate calcium. Like YAZ, there is 20 mcg ethinyl estradiol (EE) in Beyaz.
As stated in this 2012 FDA Beyaz report, there have been no epidemiologic studies to date that have addressed safety concerns done specifically for Beyaz. This FDA report does, however, refer to the one medical study (Lidegaard et al., 2011) that assessed the risk of venous thromboembolism (VTE) events -- such as deep vein thrombosis (DVT) and pulmonary embolism (PE) -- for the 20 mcg EE product without levomefolate calcium contained in Beyaz, and points out that the incidence rate of VTE was similar to that for the 30 mcg EE product. See: "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.
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This new FDA report also informs us that the Adverse Event Reporting System (AERS) database contained 467 reports for Beyaz made during the period September 2010 to May 1, 2012. It is commonly recognized that serious side effects are "under-reported" to this FDA voluntary reporting program, with some estimates being that only 1% to 10% of such adverse reactions / incidents are the subject of an FDA MedWatch Report that is put into the AERS database.
In the "Conclusion" section this FDA Beyaz Safety Review makes clear this point:
The [epidemiologic studies done to date] demonstrated clearly that the drospirenone-containing contraceptives have had substantial use by women 10 to 24 years of age and the relative risk of VTE appeared higher for women younger than 30 years of age. [emphasis added]
And earlier in this 2012 report about Beyaz done by FDA staff, we find their "take-away", or impressions, as regards the DRSP birth control pill safety studies that have been completed thus far:
Other than the studies required by regulatory agencies (Seeger 2007, Dinger 2007) [i.e., those sponsored by Bayer Healthcare Pharmaceuticals, Inc.], which showed no increased VTE risk, most other epidemiologic studies reported a two- to three-fold increased VTE risk with drospirenone-containing products compared to other progetin-containing products and it is expected that Beyaz would demonstrate a similar safety profile. [emphasis added]
Unfortunately, as this September 11, 2012 meeting of the FDA's Pediatric Advisory Committee will include the consideration of many other drugs besides Beyaz, it is unlikely that too much time will be spent discussing the Beyaz safety issues. We will, however, be watching for any related developments that may come out of this upcoming FDA meeting.
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