European Review: VTE Risks Differ for Combo Birth-Control Pills

Shelley Wood

Disclosures

October 11, 2013

LONDON, UK — The benefits of all combined hormonal contraceptives (CHCs) in preventing unwanted pregnancies outweigh the risks of venous thromboembolism (VTE), the European Medicines Agency's (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) has concluded. The PRAC review states that there are "small differences" between different CHCs, depending on the type of progestogen they contain, and that doctors can take these into account when prescribing the drugs.

The EMA announced the conclusions of its eight-month-long review earlier today.

"There is no reason for women who have been using CHCs without any problem to stop taking the medicines on the basis of this review," the announcement reads. "It is important that women are made aware of the risk of VTE and its signs and symptoms and that doctors take into consideration a woman's individual risk factors when prescribing a contraceptive."

Concerns have been mounting over the VTE, stroke, and MI risks of so-called third- and fourth-generation combination pills—pills that contain both very low doses of synthetic estrogen and new forms of synthetic progestin, namely desogestrel, gestodene, and norgestimate for the third generation and, for the fourth generation, drospirenone. The FDA added a warning to drospirenone-containing pills in 2012.

In the summary of its conclusions released today, PRAC stated that risk of VTE is lowest with drugs containing the progestogens levonorgestrel, norgestimate, and norethisterone, higher with the etonogestrel and norelgestromin, and possibly highest with pills containing gestodene, desogestrel, and drospirenone. For other synthetic progestogens, the committee said it had insufficient evidence to issue conclusions but said that "further studies are ongoing or planned."

The PRAC's function is to make recommendations that are then forwarded to the Committee for Medicinal Products for Human Use, which will adopt a "final opinion" at its November 18–21 meeting.

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