EMA Reviews Effect of Weight on Emergency Contraceptives

The European Medicines Agency will review emergency contraceptives to discover whether increased bodyweight or body mass index makes them less effective in preventing pregnancy.

The regulator’s Committee for Medicinal Products for Human Use has started a review of the medicines, which are taken after unprotected intercourse or when standard contraceptives fail, the London-based agency said today in a statement.

New data suggests that high bodyweight reduces the efficacy of emergency contraceptives, EMA said. The review began at the request of Sweden’s medicines regulator. Being overweight is increasingly prevalent worldwide and in Europe. More than half of Europeans are considered overweight and about 23 percent of women there are considered obese, according to the World Health Organization.

Access to emergency contraception varies across the continent, according to the European Consortium for Emergency Contraception, a network of organizations and individuals working in the field. For the most widely available type, seven countries, including Germany, Italy and Poland require a prescription while in most others, including France, Spain and the U.K., the pills are available without a prescription.

The pills in question contain a hormone called levonorgestrel or the agent ulipristal acetate and carry brand names including Norlevo, Levonelle/Postinor, Levodonna and ellaOne. They are taken up to 72 hours after intercourse, while ulipristal acetate can be taken up to 120 hours later.

Postinor is made by by Bayer AG (BAYN), Levodonna by Novartis AG and Norlevo and ellaOne by Paris-based HRA Pharma.

Norlevo now carries a statement in its product information that its efficacy was lower in trials in women who weighed 75 kilograms (165 pounds) or more and that levonorgestrel wasn’t effective in those who weigh more than 80 kilograms, according to EMA.

To contact the reporter on this story: Andrea Gerlin in London at agerlin@bloomberg.net

To contact the editor responsible for this story: Phil Serafino at pserafino@bloomberg.net

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