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FDA Will Decide Whether Plan B’s Warning Label Should Say It’s Less Effective For Heavier Women

The Food and Drug Administration (FDA) will review the scientific evidence suggesting that Plan B, the most popular type of emergency contraception in the U.S., may not be as effective for heavier women. On Monday, health regulators indicated they will decide whether the pill’s packaging needs to be updated to reflect the potential weight limit.

The FDA is responding to the news that a similar type of emergency contraception sold in Europe — a morning after pill called Norlevo — now comes with a warning label that the drug may not work as well for women over 165 pounds, and that it could be completely ineffective for women over 176 pounds. Mother Jones first reported on the update to Norlevo’s packaging on Monday. Norlevo is nearly identical to Plan B One-Step in the U.S., which is currently the only morning after pill sold over the counter to women of all ages.

“The FDA is currently reviewing the available and related scientific information on this issue, including the publication upon which the Norlevo labeling change was based,” an FDA spokeswoman told Mother Jones. “The agency will then determine what, if any, labeling changes to approved emergency contraceptives are warranted.”

A spokesperson for Teva Pharmaceuticals, the company that manufactures Plan B One-Step, declined to comment on whether its product was identical to Norlevo. But Teva did acknowledge that both types of emergency contraception rely on the same active ingredient, levonorgestrel, to prevent pregnancy.

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The European company that manufactures Norlevo sought approval for the change after a 2011 study found that levonorgestrel-based emergency contraception is less effective for women with a higher Body Mass Index (BMI). On the whole, there hasn’t been a lot of research into how weight could impact birth control. The FDA did not look into that area when the agency first approved Plan B for sale.

The FDA approved Plan B in 2011, although the White House imposed arbitrary age restrictions on the over-the-counter sales of the drug. In June, those age limits were finally lifted — but only for Teva’s specific product. The FDA currently has an arrangement with Teva that gives Plan B One-Step a monopoly on over-the-counter sales to younger women. The generic versions of Plan B cannot change their own warning labels unless Teva decides to change its packaging, or unless the FDA steps in to intervene.