Public Citizen Warned about Desogestrel

Vancouver, CanadaWomen who take birth control containing desogestrel may not be as concerned about desogestrel side effects as women who take other forms of birth control. After all, there has not been a lot of media coverage concerning oral contraceptives that contain desogestrel. But back in 2007, the US Food and Drug Administration was petitioned to take desogestrel birth control products off the market, due to the risk of venous thrombosis. More recently, a study has found an increased risk of gallbladder disease in women who use desogestrel-based birth control.

Researchers studied the records of 2.7 million women who used birth control. Although many newer birth controls carry a risk of gallbladder disease, the risk associated with desogestrel-based birth control was increased by five percent compared with older oral contraceptives.

In 2007, the public advocacy group Public Citizen sent a petition to the FDA, urging the agency to ban third-generation oral contraceptives that contained desogestrel. Public Citizen cited the increased risk of venous thrombosis as a reason for banning the contraceptive. According to the petition, third-generation oral contraceptives that contain desogestrel carried approximately double the risk of venous thrombosis compared with the second generation of oral contraceptives.

"The use of any combined oral contraceptives has long been associated with an increased risk of venous thrombosis," Public Citizen argued in the petition. "But three independent studies published in December 1995 all concluded third generation oral contraceptives had about twice the risk of venous thrombosis when compared to second generation oral contraceptives."

Meanwhile, a study from New Zealand, cited by Public Citizen, found that the increased risk of death from pulmonary embolus for women who took desogestrel was 14.9 to 1, while the increased risk of death from a pulmonary embolus for women who took levonorgestrel (a second-generation oral contraceptive) was 5.1 to 1.

Furthermore, Public Citizen argued, there was a lack of evidence of benefits of third-generation contraceptives when compared to second-generation contraceptives.

"By banning third generation oral contraceptives, the FDA will potentially save hundreds of young women a year from developing venous thrombosis and its disabling and sometimes fatal consequences," Public Citizen wrote. Furthermore, by switching from third-generation to second-generation oral contraceptives, four deaths per 1,000,000 woman-years could be prevented, one study suggested.

"Although third generation OCs [oral contraceptives] have not shown any clinically significant benefit over second generation oral contraceptives, multiple studies and two meta-analyses show third generation oral contraceptives containing desogestrel are associated with a higher risk of venous thrombosis than are the second generation oral contraceptives," Public Citizen wrote, concluding that desogestrel should be banned from the market.