AP: First over-the-counter birth control pill gets FDA approval

[Cooked Crack]

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U.S. officials have approved the first over-the-counter birth control pill, which will let American women and girls buy contraceptive medication from the same aisle as aspirin and eyedrops. 

 

The Food and Drug Administration said Thursday it cleared Perrigo’s once-a-day Opill to be sold without a prescription, making it the first such medication to be moved out from behind the pharmacy counter. The company won’t start shipping the pill until early next year, and there will be no age restrictions on sales. 

 

Hormone-based pills have long been the most common form of birth control in the U.S., used by tens of millions of women since the 1960s. Until now, all of them required a prescription.

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Perrigo submitted years of research to FDA to show that women could understand and follow instructions for using the pill. Thursday’s approval came despite some concerns by FDA scientists about the company’s results, including whether women with certain underlying medical conditions would understand they shouldn’t take the drug. 

 

FDA’s action only applies to Opill. It’s in an older class of contraceptives, sometimes called minipills, that contain a single synthetic hormone and generally carry fewer side effects than more popular combination hormone pills.

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Newer birth control pills typically combine two hormones, estrogen and progestin, which can help make periods lighter and more regular. But their use carries a heightened risk of blood clots and they shouldn’t be used by women at risk for heart problems, such as those who smoke and are over 35. 

 

Opill has only progestin, which prevents pregnancy by blocking sperm from reaching the cervix. It must be taken around the same time daily to be most effective. 

 

In its internal review published in May, the FDA noted that some women in Perrigo’s study had trouble understanding the drug’s labeling information. In particular, the instructions warn that women with a history of breast cancer should not take the pill because it could spur tumor growth. And women who have unusual vaginal bleeding are instructed to talk to a doctor first, because it could indicate a medical problem.

https://apnews.com/article/birth-control-pills-without-prescription-fda-b6728e98af5f1625520e0fa5fbc911c3

 

[Califan007 The Constipated]

Waiting for the Republican overreaction...

[LadySkinsFan]

Probably a House bill to outlaw birth control.