BREAKING FDA advisers have voted unanimously in favor of allowing the birth control pill Opill to be sold over the counter.
When Caitlyn Pace moved from the United States to Hong Kong three years ago to take a teaching job, she loved the food, the sights and the birth control.
On Tuesday and Wednesday, a group of external advisers to the US Food and Drug Administration will discuss an application from a pharmaceutical company to put their prescription birth control pill over the counter. One has to do with obesity. The FDA approved Opill as a prescription drug in 1973, and "the prevalence of obesity in adults in the United States has changed dramatically since the original clinical studies were conducted over 50 years ago," the scientists wrote in the document, citing a 13% obesity rate in 1960 compared with a 42% obesity rate now.
The FDA scientists were also concerned that studies by Perrigo, the company that manufactures Opill, showed some women didn't follow the label instructions. They said some women in the study didn't take the pill within the same three-hour window every day, which is important for efficacy. The FDA also expressed concern that without counseling from a doctor, women might not realize when Opill wasn't appropriate for them.
Österreich Neuesten Nachrichten, Österreich Schlagzeilen
Similar News:Sie können auch ähnliche Nachrichten wie diese lesen, die wir aus anderen Nachrichtenquellen gesammelt haben.
Gardopia Gardens food and nature conference to focus on food insecurity and climate changeThe 3rd Annual Food & Nature Conference will highlight what actions some local organizations are taking and offer simple solutions through onsite workshops
Weiterlesen »
FDA raises concerns about over-the-counter birth control pillU.S. regulators will vote this week on whether the contraceptive Opill should be made widely available without a prescription.
Weiterlesen »
FDA advisory committees meeting to discuss over-the-counter birth controlAdvisory committees of the U.S. Food and Drug Administration are meeting Tuesday and Wednesday to review the first-ever application for an over-the-counter birth control pill.
Weiterlesen »
FDA may allow birth control pill without prescription this summer as experts weigh dataHRA 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.
Weiterlesen »
FDA Experts to Consider First Over-the-Counter Birth Control PillAs a U.S. Food Drug Administration advisory panel prepares to weigh whether to recommend that a birth control pill be sold over the counter in this country, a coalition of advocates on Monday called attention to the safety and effectiveness of the medication.
Weiterlesen »
‘Caught between a rock and a hard place’: FDA considers over-the-counter birth controlThe agency is slated to make a decision on approval of the daily hormonal pill by this summer.
Weiterlesen »