SUMMARY: In the past few years following an April 2012 YAZ label change there has emerged more medical evidence in support of the contention that birth control pills containing drospirenone (DRSP) are associated with higher rates of side effects caused by blood clots, such as deep vein thrombosis (DVT), pulmonary embolism (PE), strokes, and heart attacks.
As you may recall, the drug labels for Yasmin, YAZ, Safyral, and Beyaz were revised by Bayer and the FDA in April 2012 by adding information about the several different and conflicting (in terms of their conclusions) medical studies concerning the increased blood clot risks associated with drospirenone-containing birth control pills.
This “new” (vis-à-vis the April 2012 YAZ label change) medical evidence raises the possibility of there being another revised label for drospirenone birth control pills with a stronger and more clear, i.e., less ambivalent, warning about the increased risks of serious side effects involving blood clots.
There is a precedent for there being more than one such drug label change required by the FDA for contraceptive products like YAZ, Yasmin, Beyaz, and Safyral.
Back in 2008 we wrote this blog post, “Blood-Clot Warning On Ortho Evra Birth Control Patch Increased, Again, In January 2008”, which had as its sub-title: “Label For ‘The Patch’ No Longer Has Conflicting Information About Its Increased Risk Of Blood Clots” [emphasis added].
Given the mounting medical evidence that there is a real increased risk — not an arguable or theoretical risk — of developing a DVT, PE, stroke, or heart attack while using Beyaz, Safyral, Yasmin, or YAZ, one wonders whether DRSP birth control pills will follow the course of there being another blood-clots warning label change, as was done with the Ortho Evra patch.
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Beyaz/Safyral/YAZ/Yasmin/Ocella/Gianvi
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