Due to the influx of adverse events associated with drospirenone-containing contraceptives, officials from the U.S. Food and Drug Administration (FDA) convened on December 8 to discuss future regulations of newer birth control pills. According to a panel of outside experts, Yaz and Yasmin labels do not provide an adequate warning pertaining to the risk of severe, life-threatening blood cots. In a majority vote, panel experts voted 21 to 5 in favor of updating the current labels to include an emphasis on such adverse events.
Current labeling practices by the makers of Yaz and Yasmin acknowledge an increased risk of blood clots. However, labels suggest that their newer oral contraceptives have similar risks of blood clots to those of older birth control pills that combine estrogens and progestins. Accordingly, experts at the recent meeting have suggested that the evidence indicated on current labels is conflicting and deceiving.
As an advocate for the FDA, Morgan Liscinsky acknowledged that the panel of experts “definitely felt that stronger labels were needed, that the labels need to be updated to reflect current data and acknowledge that it is conflicting.”
Contradictory to what the panel of experts has concluded, are the opinions of Bayer, the pharmaceutical company responsible for the development and distribution of Yaz and Yasmin. According to the Germany based company, their newer contraceptives pose no greater threat than other birth control pills, all of which demonstrate a propensity for elevating the risk of severe, life-threatening blood clots in the legs and lungs. Subsequently, Bayer suggests any tests refuting their findings may harbor methodological flaws that undercut the strength of their results.
However, several reputable studies suggest otherwise, including on by the FDA. Research has indicated that drospirenone may significantly increase the risk of severe, life-threatening blood clots. An FDA analysis reported that about 10 in 10,000 women taking pills with drospirenone will experience a blood clot or venous thromboembolism in a year, compared with 6 in 10,000 women using other hormonal contraceptives.
Researchers from the Boston Collaborative Drug Surveillance Program at Boston University School of Medicine examined close to 900 women who have been using contraceptives since 2002. Women who were taking Yaz or Yasmin, saw a rate of blood clots that reached 30.8 per 100,000 person-years. For women talking levonorgestrel-based pills, the rate was only 12.5 per 100,000 person-years. Women taking drospirenone-containing oral contraceptives were about twice as likely to develop a dangerous blood clot.
The author of the aforementioned study concluded that “these findings support more recent studies that suggest that drospirenone oral contraceptives are not as safe as levonorgestrel oral contraceptives with respect to venous thromboembolism.”
However, conflicting results in several studies left the nature of fourth generation contraceptives more ambiguous than ever. As a result, the FDA convened their December 8 meeting to obtain a better understanding of newer birth control pills.
Although the agency could not determine whether the increased risk resulted from use of the drugs or some other cause, they “believe that, because of the consistency in recent reports for an increased risk, product labeling should reflect that very real possibility,” the scientists wrote.
Prior to the conclusion of the advisory committee, the panel of experts voted, 15 to 11, that the benefits of the pills still outweigh their risks of dangerous blood clots. While the FDA does not have to follow the panel’s recommendations, the agency has indicated significant concern in recent months as some studies, including its own, have shown an elevated risk.
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