Same General Warning About All COCs Was Added To YAZ In March 2011; And Why The One Year Delay, We Wonder
(Posted by Tom Lamb at DrugInjuryWatch.com)
The February 14, 2012 email captioned "What's New on the FDA Drugs Site" let us know that there was a new version of the Package Insert for Yasmin, Safyral, and Beyaz which consisted of four new sentences being added to the WARNINGS AND PRECAUTIONS section:
5.1 Thromboembolic Disorders and Other Vascular Problems
... The risk of VTE in women using [combined oral contraceptives (COCs)] has been estimated to be 3 to 9 per 10,000 woman-years. The risk of VTE is highest during the first year of use. Data from a large, prospective cohort safety study of various COCs suggest that this increased risk, as compared to that in non-COC users, is greatest during the first 6 months of COC use. Data from this safety study indicate that the greatest risk of VTE is present after initially starting a COC or restarting (following a 4 week or greater pill-free interval) the same or a different COC.
Source: Yasmin Package Insert (Revised 2/2012)
As you can see, there is nothing specific in this new warning about Yasmin, Safyral, nor Beyaz.
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Moreover, this very same change was made to the YAZ label in March 2011, almost a full year ago, something we wrote about in this earlier article, "Another Rather "Odd" YAZ Label Change By Bayer: March 2011":
The bottom line is this: There is nothing specific about YAZ in the new warning language added to the YAZ label by Bayer in March 2011. Instead, these new warnings pertain to ALL combined oral contraceptives (COCs), or birth control pills.
Moreover, one expects a similar "odd" label change will be done for the several other Bayer birth control pills which contain drospirenone (DRSP) and ethinyl estradiol (EE), namely Yasmin, Safyral, and Beyaz -- while, again, stating nothing that is specific to each.
Well, that label change for Yasmin, Safyral, and Beyaz is finally here and, like the warning added in March 2011 to YAZ, it is odd that this new warning is non-specific to these particular Bayer birth control pills.
Lastly, what took Bayer and the FDA so long to make this simple label change...?
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