Drugs Pharma

Plan B contraceptive pill not an abortion drug, states FDA

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HQ Team

December 24, 2022: The Food and Drug Administration (FDA)has amended the information on the label of Plan B One-Step, the emergency contraceptive pill, making it clear that it does not affect a fertilized egg’s ability to implant in the uterus in any way.

Till date, the packages of the brand pill Plan B One-Step said that the pill prevents a fertilized egg from implanting in the womb, which had no scientific basis.

This information was used by many anti-abortion activists to say that taking a morning after pill was as good as having an abortion.

The agency has put out a document clarifying that the products cannot be described as abortion pills.

The new leaflets to accompany the pill packages will now state that the drug  “works before release of an egg from the ovary,” meaning that it acts before fertilization, not after. The package insert also says the pill “will not work if you’re already pregnant, and will not affect an existing pregnancy.”

On its website, the FDA has clearly stated in its FAQ that “evidence does not support that the drug affects implantation or maintenance of a pregnancy after implantation; therefore, it does not terminate a pregnancy.”

Plan B was approved in 1999 and is available without a prescription. A recent study found that nearly 60 percent of participants of 1,400 people surveyed believed that morning-after pills work by preventing the implantation of a fertilized egg.

Nearly a decade ago, in 2012, a New York Times investigation had proved that “the emerging data on Plan B suggest that it does not inhibit implantation.”

Following this investigation and an acknowledgement by the FDA of the same, the National Institutes of Health deleted passages suggesting emergency contraceptives could disrupt implantation.. In 2013, European health authorities revised the label of Norlevo, a pill that is identical to Plan B, to say that it “cannot stop a fertilized egg from attaching to the womb.”

The label wordings were changed following a review based on a 2018 application by the Foundation Consumer Healthcare, a company that bought the Plan B brand in 2017 from Teva Pharmaceutical Industries.

“As the label was written previously, it was causing more confusion and was incorrect according to the scientific research,” the company’s marketing director, Tara Evans, said. “Our goal was to clarify misinformation,” she said, adding that “the events of 2022 reignited the urgency.”

Plan B One-Step and its generic versions contain levonorgestrel, which is found at lower doses in birth control pills and intrauterine devices. The pills are most effective in preventing pregnancy if taken within 72 hours of sexual intercourse.

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