Quoted from http://www.reuters.com/article/2011/12/09/us-fda-birthcontrol-patch-idUSTRE7B827N20111209
FDA advisers: Ortho Evra patch needs clearer label
By Alina Selyukh
ADELPHI, Maryland | Fri Dec 9, 2011 6:13pm EST
ADELPHI, Maryland (Reuters) - U.S. drug advisers recommended that the label for Johnson and Johnson's Ortho Evra birth control patch be simplified to better explain the risk of blood clots.
In a 20 to 3 vote with one abstention, advisers to the Food and Drug Administration found that the current label for Ortho Evra inadequately reflects the risks women face by using it. It is the only contraceptive patch sold in the United States.
The panel voted 19 to 5 that the patch's risks were outweighed by its benefits, such as pregnancy prevention through a once-weekly application.
"I'm satisfied generally with what the content is for this label, it's the understandability and presentation that needs some work," said Jacqueline Gardner, panel member and a University of Washington professor.
All commonly used birth control pills increase women's chances of getting blood clots. The patch, approved in 2001, has been linked to an even higher risk as it contains a much greater amount of the hormone estrogen than a pill.
The current label, which has undergone numerous revisions over the past decade, has a boxed warning of a higher risk compared to older birth control pills. But a new FDA study earlier this year again showed that women using the patch were about 60 percent more likely to experience venous thrombotic events (VTEs).
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