1. Health
Dawn Stacey M.Ed, LMHC

FDA Orders Updated Labeling for Some Birth Control Pills — How Does This Affect YOU?

By April 13, 2012

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Back in December of last year, the Reproductive Health Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee voted of 21-5, that the FDA should revise the labels of birth control pills that contain the progestin, drospirenone - such as Yaz, Yasmin, Beyaz, Safyral (and their generic versions).

In response to this vote, the FDA has released an updated safety announcement about these pills as well as new labeling requirements. Based on recent studies as well as the FDA's own in-depth study that investigated the relationship between VTE risk (blood clots) and combination hormonal contraception, the FDA is now requiring that drospirenone-containing pill labels reference the results of the recent literature, including the FDA's self-funded investigation. This means that the labels will now have to reflect that, as compared to use of combination pills that contain different progestins, pill use with drospirenone is linked to a blood clot risk that can range from no increase to a three-fold increase.

It appears that the FDA did not follow the advisory panel's recommendation to require new labels that more clearly explain the potential blood clot risk. Before this labeling update, the labels on these pills already cited some research. The advisory panel was concerned over the fact that the cited literature was conflicting. The new required drug labels will also reference conflicting data, yet the FDA explains that this is because the newer research simply doesn't provide consistent estimates of the risk of blood clots. The FDA is also concerned that these studies also don't account for patient factors/characteristics that may influence whether or not a doctor prescribes these pills. As per the FDA, "it is not possible to provide a definitive statement about how the risk of blood clots may differ for drospirenone-containing birth control pills compared to pills that contain levonorgestrel or some other progestin."

As of now, the FDA has only indicated that these pills may be associated with a higher VTE risk -- so if you are using one of these pills, don't panic! The research is conflicting, and the OVERALL risk for blood clots while using these pills is still significantly lower than the risk associated with being pregnant or after giving birth. So, keep this all in perspective. Drospirenone-containing pills can offer you some great non-contraceptive benefits and are an effective birth control method. You can always talk to your doctor if you are having any concerns. But as of now, the FDA is still recommending that if you have been prescribed these pills, to continue using them unless told otherwise by your doctor.

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Photo 2011 Dawn Stacey

July 30, 2012 at 7:25 am
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