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FDA panel reviews VTE risk for some OCs.


ADELPHI, MD. -- The benefits of Yasmin and other drospirenone-containing oral contraceptives outweigh their risks, but more information about the agents" risk-benefit profile needs to be added to the labels, according the majority of a Food and Drug Administration advisory panel.

The agency convened a joint meeting of the Reproductive Health Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee to review the conflicting results of numerous epidemiologic studies evaluating the risk of venous thromboembolic events (VTEs) associated with Yasmin, Yaz, and other combined oral contraceptives (COCs) that contain drospirenone (DRSP) as the progestin component. Panelists voted 15-11 that the benefits of these products for preventing pregnancy in the general population of women outweighed their risks, and voted 21-5 that the labels for these products did not adequately reflect available information about their risk-benefit profile.

In 2001, Yasmin (0.03 mg of ethinyl estradiol with 3 mg of DRSP) was the first COC that contained DRSP, a spironolactone analogue with antimineralcorticoid activity and antiandrogenic activity, that was approved, followed by Yaz (0.02 mg of ethinyl estradiol with 3 mg of DRSP) in 2006, and Safyral and Beyaz, folate-containing versions of Yasmin and Yaz, respectively, which were approved in 2010. Some generic formulations are also available.

Postmarketing studies conducted by the manufacturer of Yaz, Safyral, Yasmin, and Beyaz, Bayer HealthCare Pharmaceuticals, in Europe and the United States, found no increased risk of VTEs, compared with other COCs. But other epidemiologic studies, including a recently reported FDA-funded study of more than 800,000 women, have found an increased risk of VTE associated with these products, when compared with standard low-dose COCs.

Some of the information about VTE risk has been added to the labels of these products, but panelists recommended providing more information, which would help clinicians counsel patients. Those who voted that the benefits outweighed the risks said that if the risk was elevated, it was modest, adding that it is important to have more contraceptive choices available. Those who voted that the benefits did not outweigh the risks said there were no unique benefits of DRSP-containing COCs over other available alternatives.

Relatives of several young women who had fatal pulmonary emboli while on Yaz testified during the open public hearing portion of the meeting, calling for the withdrawal of DRSP-containing contraceptives from the market, as did several women's health advocates who also testified.

The FDA's assessment of the available data indicates that these products, primarily Yasmin, appear to be associated with an increased VTE risk, compared with COCs that contain other progestins, an FDA official said at the meeting, But because many factors can influence risk, data need to be re-analyzed to evaluate the impact of these risk factors before "before we can conclude that Yasmin carries an increased risk of VTE," the official said. (She referred to Yasmin since that is the most studied of all these products.)

The FDA usually follows the recommendations of its advisory panels, which are not binding. Panelists have been cleared of potential conflicts of interest related to the topic of the meeting. Occasionally, a panelist may be given a waiver, but not at this meeting.
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Title Annotation:NEWS; venous thromboembolism; oral contraceptive
Comment:FDA panel reviews VTE risk for some OCs.(NEWS)(venous thromboembolism)(oral contraceptive)
Author:Mechcatie, Elizabeth
Publication:Family Practice News
Geographic Code:1USA
Date:Jan 1, 2012
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