The Food and Drug Administration on Friday announced that it is changing the informational packaging of the emergency contraceptive pill, Plan B One-Step, to clarify that it is not an abortion pill.
Plan B One-Step is an emergency contraceptive, a backup method to other birth control. It is in the form of one levonorgestrel pill (1.5 mg) that is taken by mouth after unprotected sex or contraceptive failure. The most important factor affecting how well emergency contraception works is how quickly it is taken after unprotected sex or contraceptive failure.
Therefore, FDA recommends that all people using levonorgestrel emergency contraceptives follow the product directions exactly and take the product as soon as possible within 72 hours after unprotected sex or contraceptive failure, the agency said.
“Plan B One-Step will not work if a person is already pregnant, meaning it will not affect an existing pregnancy. Plan B One-Step prevents pregnancy by acting on ovulation, which occurs well before implantation,” the FDA said in a release. “Evidence does not support that the drug affects implantation or maintenance of a pregnancy after implantation, therefore it does not terminate a pregnancy.”
Packaging for Plan B and generic version of the drugs have, until now, claimed that taking the pill might be able to prevent a fertilized egg from implanting. However, medical professionals say this claim is not backed by scientific evidence but was included on the label in order to get Plan B’s over-the-counter status approved.
The agency said the following statements are retained in the Consumer Information Leaflet:
- Under the heading “What Plan B One-Step is not,” the following statement will remain: “Plan B One-Step will not work if you are already pregnant and will not affect an existing pregnancy.”
- Under the heading “When not to use Plan B One-Step,” the following statement will remain: “Plan B One-Step should not be used if you are already pregnant, because it will not work.”
The agency recommends that consumers talk with their doctors about emergency contraceptives so they understand “the importance of using these products as intended.”
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