VTE Risk for Newer Oral Contraceptives to Be Studied by EMA


January 28, 2013

The European Medicines Agency (EMA), the European equivalent of the US Food and Drug Administration, announced today that it will study whether there is a need to restrict the use of third- and fourth-generation combined oral contraceptives to women who cannot take earlier versions of "the pill."

The underlying concern is venous thromboembolism (VTE), a rare risk associated with all oral contraceptives. The risk is higher for third- and fourth-generation oral contraceptives than for their forerunners, according to the EMA.

Combined oral contraceptives contain both synthetic estrogen and progestin. What largely characterizes the different generations of these drugs is the molecule used as the progestin component.

France asked the EMA to conduct the review "amid recent initiatives to reduce the use of third- and fourth-generation combined oral contraceptives...in favour of using second-generation oral contraceptives," the agency stated in a news release.

The French government announced earlier this month that it would no longer reimburse the prescription costs of third- and fourth-generation pills after a woman sued a manufacturer over alleged adverse effects, according to Reuters.

The EMA conducted a similar review almost a dozen years ago, comparing the VTE risk for third-generation combined oral contraceptives containing the progestins desogestrel or gestodene to the second-generation pill containing the progestin levonorgestrel and the same level of ethinylestradiol, the estrogen component. The EMA concluded in 2001 that women have a small increased risk for VTE using the third-generation pill. However, because the "balance of benefits and risks remains favorable with all available combined oral contraceptives," there was no reason for women to stop taking any brand of the pill. The EMA also noted that pregnancy raises the risk for VTE more than combined oral contraceptives.

This time around, the EMA's Pharmacovigilance Risk Assessment Committee will render an opinion on whether the current product information for third- and fourth-generation combined oral contraceptives provides the best guidance to clinicians and patients. More information about the current review will be published after the committee's next meeting in the first week of February.

Women with concerns about their oral contraceptive should talk with their physician, the EMA said. However, "there is no reason for any woman to stop taking her contraceptive."

More information about the EMA announcement is available on the agency's Web site.