HRA Pharma asked the Food and Drug Administration to allow over-the-counter sales of Opill after the Supreme Court said there was no federal right to abortion.
The concerns by FDA staff about whether enough people will understand Opill's warning label are focused on women with a history of breast cancer and those with unexplained vaginal bleeding.
Women who have experienced unexplained bleeding between menstrual cycles are supposed to consult with their doctor to make sure norgestrel is safe for them. HRA Pharma said 22 women reported unexplained vaginal bleeding that they had not discussed with a doctor at study enrollment. Seven of these individuals chose to take Opill during the study. One of these participants spoke to a doctor during the study, while six did not.
These factors could affect Opill's effectiveness at preventing pregnancy in a nonprescription setting, according to the FDA.
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