November 10, 2005 - Food and Drug Administration –

On Novermber 10, 2005 the American Food and Drug Administration (FDA) approved changes to the labeling information of Ortho Evra, one of the most popular and widely-used birth control methods in the USA.

Ortho Evra is a prescription contraceptive in the form of skin patch, produced by Ortho McNeil Pharmaceuticals. As well as Ortho Tri Cyclen, which goes in the form of oral pills, this birth control method ensures up to 99% efficiency in postponing pregnancy by supplying estrogen to human blood stream.

Usually, a woman should take a birth control pill once a day, while the patch is applied once a week. Often it is rather difficult to follow such daily regimen with pills, therefore women prefer patch, ensuring the protection for 7 days. That is why a patch is surely more comfortable, as it lets women feel freer and not worry about the protection every day.

Ortho Evra is considered to be safer medication, because it provides more stable and constant supply of estrogen, avoiding the so called “estrogen peaks”, usual for oral pills. When a person takes a pill, the level of estrogen in blood jumps approximately 25% higher in comparison to the situation when a person uses patch. However, after such peak, caused by an estrogen containing pill, the hormone level returns to its usual level, while a patch produces lower but more permanent and long-lasting supply of estrogen to blood flow.

As a result, total amount of estrogen in blood is about 60% higher when a woman uses Ortho Evra in comparison to the amount of hormone, supplied by traditional birth control pill. That is a result, received from the analysis by FDA and a manufacturer, comparing the levels of estrogen in users of Ortho Evra and traditional birth control pills.

The main concern of scientists and medical authorities is the fact that increased level of estrogen may cause certain health problems, such as blood clots in legs or lungs and other clotting problems like strokes and heart attacks.

Though FDA states in its press release, that it is still not known whether patients, using Ortho Evra are in greater risk of having blood clots than those, taking birth control pills with estrogen, the decision to make a label revision for this medication was made to warn health care providers and patients about the potential side effects.

Nick

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External resources
http://www.fda.gov/bbs/topics/NEWS/2005/NEW01262.html
http://www.fda.gov/cder/drug/infopage/orthoevra/qa.htm

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