EMA Investigates whether Emergency Contraceptives are Effective for Overweight Women
The European Medicines Agency (EMA), the regulatory authority in Europe similar to the United States Food and Drug Administration (FDA), is investigating whether emergency contraceptives, known as the “morning-after pill”, are effective in women who are overweight or obese.
On January 24, 2014, the EMA issued a statement indicating that they have “started a review of emergency contraceptives to assess whether increased bodyweight and body mass index (BMI) reduce the efficacy of these medicines in preventing an unintended pregnancy following unprotected sexual intercourse or contraceptive failure.” The EMA added that they intend to “evaluate the impact of new data suggesting that a high bodyweight could impair the effectiveness of emergency contraceptives…. [and] assess whether any changes should be made to the product information for all emergency contraceptive medicines containing levonorgestrel or ulipristal acetate.”
CBS reports that this announcement follows a November 2013 report that some morning-after pills may not be effective for overweight women. At that time, HRA Pharma, one of the manufacturers of a morning-after pill in Europe (Norlevo), said that European regulators approved a request to change the pill’s packaging label to warn women that Norlevo was not effective in women who weighed more than 176 pounds, and that the pill lost efficacy in women who weighed over 165 pounds. The manufacturer determined that increasing the dosage did not approve efficacy and determined that the use of the product for overweight and obese women was not recommended.
The morning-after pill refers to a group of oral medications intended to prevent unwanted pregnancy after unprotected sex in the event that the main form of contraception fails. In the United States, there are three types of morning-after pills available: Plan B One-Step, Plan B, and Ella. Plan B One-Step, which is available over-the-counter for women of all ages, is a two-pill medication that will harm a fetus if the woman is already pregnant. Plan B is available over-the-counter for women 17 and older, and with a prescription for anyone under the age of 17. Ella is only available with a doctor’s prescription, regardless of the woman’s age.
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