FDA Reviewing Efficacy of “Morning After Pill” in Women Weighing Over 165 Pounds

morning-after-pill-effectivenessUnited States health regulators just announced that they are reviewing the efficacy of Plan B emergency contraceptive pills as they may not offer the same benefits in women who weigh more than 165 pounds.

In the U.S., the Plan B emergency contraceptive pills are sold under the brand name Plan B One-Step, and are also sold in generic versions, according to The Wall Street Journal. The pills are sold worldwide under other names, such as Norlevo in Europe. The pills appear to lose their effectiveness in women who weigh more than 165 pounds and the U.S. Food and Drug Administration is considering including a revised product warning.

The Plan B emergency contraceptive pill, also known as the “Morning After Pills,” are taken by millions of women following intercourse to prevent pregnancy, The Wall Street Journal explained.

European health regulators told HRA Pharma, the maker of Norlevo, that it should revise the drug’s label to indicate that the pills begin to lose effectiveness should a woman weigh more than 165 pounds; all efficacy is lost if a woman weighs more than 176 pounds, according to the company’s chief executive, wrote The Wall Street Journal. HRA Pharma asked the European health regulators if the additional warning was needed about one year ago, following release of study findings that the pills lose efficacy as a woman’s weight increases, Erin Gainer, chief executive of HRA Pharma, told The Wall Street Journal. According to Gainer, all Norlevo packages should contain the revised labels during the first quarter of 2014.

“We felt it was our ethical duty … to report those results to our health authorities here in Europe,” Gainer said, according to CNN.

The weight issue could potentially impact many U.S. women. In the U.S., the average weight for women age 20 and over is 165 pounds, according to a study conducted by the U.S. Centers for Disease Control and Prevention (CDC). The study, explained The Wall Street Journal, took body measurements of women above childbearing age, from 2007 to 2010.

An FDA spokeswoman said it is “currently reviewing the available and related scientific information on this issue, including the publication upon which the Norlevo labeling change was based. The agency will then determine what, if any, labeling changes to approved emergency contraceptives are warranted,” The Wall Street Journal reported.

The so-called morning after pills are made with high concentrations of the female hormone progestin—progestin is also an ingredient in birth control pills—to block an egg that may have been fertilized, from becoming implanted in a woman’s uterus. Norlevo is the same as Plan B One-Step, said Kelly Cleland, a public health expert at Princeton University, wrote CNN. Both drugs are LNG ECs, or emergency contraceptives that include levonorgestrel, which is a synthetic version of the hormone, progestogen. Plan B is available in the U.S. with no prescription and to anyone of any age. The generics, Next Choice One Dose and My Way, are also the same as Norlevo, Cleland said, according to CNN.

Generic brands are not able to change labeling until the brand product label is changed, under current federal law. The new European labeling will state that the emergency contraceptive is “not recommended … if you weigh (165 pounds) or more,” according to Mother Jones, which first reported the story.

The reason for the drop in efficacy in women weighing more than 165 pounds is unclear.

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