The YAZ Label Change In March 2011 Seems Rather "Generic" In Nature
Bayer Warns About Blood Clots And Pancreatitis Side Effects As Regards ALL Birth Control Pills
By means of a March 11, 2011 Supplemental Approval letter the FDA informed Bayer HealthCare Pharmaceuticals that they could change the labeling for YAZ in the following regards:
This “Prior Approval” supplemental new drug application provides for the inclusion of new information regarding the increased risk of venous thromboembolic events (VTE) in women using combined oral contraceptives (COCs) in WARNINGS AND PRECAUTIONS, subsection Thromboembolic Disorders and Other Vascular Problems. The new information specifically concerns the temporal trend in the increased risk relative to starting a COC and alterations in the risk following temporary discontinuation and then resumption of a COC....
In addition, this supplement (1) modifies the subsection Carbohydrate and Lipid Metabolic Effects in WARNINGS AND PRECAUTIONS...
Accordingly, the revised YAZ label, or package insert, approved by FDA in March 2011 will include this additional language in its WARNINGS AND PRECAUTIONS section:
5.1 Thromboembolic Disorders and Other Vascular Problems
... The use of COCs increases the risk of venous thromboembolism. However, pregnancy increases the risk of venous thromboembolism as much or more than the use of COCs. The risk of venous thromboembolism in women using 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. Interim 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. Interim 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.
5.7 Carbohydrate and Lipid Metabolic Effects
... Women with hypertriglyceridemia, or a family history thereof, may be at an increased risk of pancreatitis when using COCs.
As such, there is nothing specific about YAZ in the new warning language added to the YAZ label in March 2011; rather, these new warnings seem to pertain to ALL combined oral contraceptives (COCs), or birth control pills.
Putting that small point aside, one supposes that there will be forthcoming in the near future a similar "generic" label change for the several other Bayer birth control pills which contain drospirenone (DRSP) and ethinyl estradiol (EE), namely Yasmin, Safyral, and Beyaz.
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