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Labeling for the European levonorgestrel (LNG) emergency contraceptive pill (ECP) NorLevo has been revised in light of data indicating lower drug efficacy in women weighing 165 pounds and above.1 This move has led U.S. regulatory officials to assess data on similar products in this country.
NorLevo, marketed by Paris, France-based HRA Pharma, contains 1.5 mg of levonorgestrel. The same formulation is found in products marketed by different manufacturers in the U.S.: Plan B One-Step (Teva Women's Health, North Wales, PA), Next Choice One Dose (Actavis, Parsippany, NJ), and My Way (Gavis Pharmaceuticals, Somerset, NJ).
The Food and Drug Administration (FDA) is reviewing available and related scientific information on this issue, including the publication upon which the NorLevo labeling change was based, states Erica Jefferson, deputy director of the FDA Office of Media Affairs. The agency will then determine what, if any, labeling changes to approved emergency contraceptives are warranted, says Jefferson.
"As background, the original approval of Plan B for use in the U.S. did not include an assessment specific to weight," states Jefferson. "NorLevo is not approved under this brand name in the U.S."
What prompted the NorLevo label change? The effect of a women's weight on levonorgestrel efficacy was first identified in 2011 during the development of an alternative emergency contraceptive product (ulipristal acetate) in the context of a clinical trial, says Erin Gainer, MPH, chief executive officer of HRA Pharma. Ulipristal acetate is marketed by Actavis in the United States as ella. (Contraceptive Technology Update reported on ella. See "Add ella to options for emergency contraception," October 2010, p. 112.)
1.5 to 3 times greater risk of pregnancy
Compared with women with a BMI under 25 kg/m2, which is normal weight or underweight, according to the World Health Organization (WHO), the risk of pregnancy was more than three times greater (OR [odds ratio], 3.60; 95% CI [confidence interval], 1.96–6.53; p less than 0001) for obese women (BMI of 30 kg/m2 and above according to WHO) and 1.5 times greater (OR, 1.53; 95% CI, 0.75–2.95) for overweight women (BMI between 25 and 30 kg/m2 ), whichever drug was taken, the researchers note.1
However, when the pregnancy rates were compared within the two treatment groups, the effect of BMI...