“We need to make it affordable,” Sen. Patti Murray, a Washington Democrat and co-sponsor of the bill, said in an interview in May. “Give women what they need and make it affordable. You don’t have to be forced not to use contraception just because you don’t want to.” Today I have the luxury,” she added.
Opil is known as a “mini-pill” because it contains only one hormone, progestin, as opposed to “combination” pills, which contain both progestin and estrogen. Cadence Health, the company that makes the combination drug, is also in talks with the FDA about applying for over-the-counter marketing authorization.
After evaluating data submitted by Perrigo for the non-prescription drug Opil, FDA analysts found that women with medical conditions that should prevent them from taking oral contraceptives, primarily breast cancer and undiagnosed vaginal bleeding, followed the warning and used contraception. He expressed concern about whether to avoid taking the drug. product. FDA analysts also questioned whether young people and people with limited literacy would be able to follow the instructions.
Several advisory panel members said doctors would typically advise patients with breast cancer, a major medical condition that prevents them from taking hormonal contraceptives, to avoid using oral contraceptives. They also said opil may actually be the safest because the chances of getting breast cancer in adolescents are very low. And because young people often start with over-the-counter contraceptives, panelists said it was especially important to have easy access to a more effective method than condoms or other contraceptives available in retail stores.
Perrigo reported that participants in one study took opil 92.5 percent of the days they should have taken it. Dr. Stephanie Sober, the company’s U.S. medical liaison, said at an advisory committee hearing that most participants who missed their pills took measures to alleviate their symptoms, such as abstaining from sex and using condoms. He said he reported that he had followed the directions on the label. Of the 955 participants, she said, only six became pregnant while taking opil.
Most of those who said they missed a dose attributed it to running out of pills before they reached the study resupply site, with the result that the missed dose “reduced the compliance barrier.” It shows exactly what it can do,” Dr. Sober said. Over-the-counter tablets available.
