Drospirenone Contraceptives Worth the Risk: FDA Panel

Emma Hitt, PhD

December 09, 2011

December 9, 2011 — A US Food and Drug Administration (FDA) advisory panel yesterday assessed the venous thromboembolism (VTE) risk associated with drospirenone-containing oral contraceptives and voted, 15 in favor and 11 against, that the benefits currently outweigh the risks.

In a second vote, the panel also recommended (21 vs 5) that the pills' labels should better highlight the risks of VTE.

The votes were cast at the first of the 2-day joint meeting of the FDA's Advisory Committee for Reproductive Health Drugs and the Drug Safety and Risk Management Advisory Committee.

The panel convened to discuss the benefits and risks of drospirenone-containing oral contraceptives in light of the emerging safety concerns that the risk for VTE associated with use of these products may be higher than that of combination oral contraceptives containing the progestin levonorgestrel.

According to the FDA, an approximately 50% increased risk for VTE is seen among women taking drospirenone-containing oral contraceptives, as reported in September by Medscape Medical News.

The first vote asked whether the panel believed that "in the general population of women who desire contraception, do the benefits of the [drospirenone]-containing oral contraceptives for prevention of pregnancy outweigh their risks?" Of the panelists, 15 voted "yes" and 11 voted "no."

Elaine Morrato, DrPH, assistant professor in the Department of Pediatrics at the University of Colorado in Denver, voted "yes" in favor of the statement. "Although the safety findings are contradictory and disturbing, it does appear that…the absolute incidence rate [of VTE] is still very rare, and it appears within the general range of currently available products."

Likewise, Robert Wild, MD, professor of obstetrics and gynecology at the Oklahoma University Health Sciences Center in Oklahoma City, who also voted in favor, pointed out that "compared with the alternative of getting pregnant, clearly it’s a benefit."

Among the no voters, Peter Kaboli, MD, associate professor, Department of Internal Medicine, University of Iowa Carver College of Medicine, Iowa City, said that he wouldn't recommend this to his patients, and "I wouldn't have my daughter take it, so I voted 'no.' "

Others who voted "no" also pointed out that the alternative to this product is not necessarily unintended pregnancy because safer alternatives are available.

In a second vote, the panelists were asked "Do you believe the current [drospirenone] labels adequately reflect the risk/benefit profile for these products?" to which 5 voted "yes" and 21 voted "no."

The panel also discussed whether the epidemiologic evidence to date was sufficient for evaluating risk because of the differences in study design.

"All of these studies have significant strengths and weaknesses," said acting chair, Julia Johnson, MD, professor and chair of the Department of Obstetrics and Gynecology at the University of Massachusetts Medical School in Worcester.

"The committee believes that a new study is needed to continue to look at the FDA data" and to consider more confounding variables, such as body mass index, smoking, and polycystic ovary syndrome, she said.

Drospirenone-containing oral contraceptives include 3 mg drospirenone/0.03 mg ethinyl estradiol (Yasmin, Bayer); 3 mg drospirenone/0.02 mg ethinyl estradiol (Yaz, Bayer); 3 mg drospirenone/0.02 mg ethinyl estradiol/0.451 mg levomefolate calcium (Beyaz, Bayer); and drospirenone/ethinyl estradiol/levomefolate calcium tablets and levomefolate calcium tablets (Safyral, Bayer), and the generic equivalents for these products.

Today's session will vote and ask similar questions about the VTE risk associated with the norelgestromin/ethinyl estradiol transdermal contraceptive patch (Ortho Evra, Jannsen)

The FDA does not always follow the advice of its advisory panels, but it usually does.


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