June 11, 2008, Washington – US advocacy group Public Citizen's Health Research, filed a petition to the Food and Drug Administration regarding Johnson & Johnson's birth control patch Ortho-Evra. This is in line with studies that have shown that using the said birth control patch increases a woman's chances of developing dangerous blood clots.

The petition included information about the said contraceptive, as well as helpful information about the female anatomy that is relevant to why Ortho-Evra is a potential hazard to women using it. The research group presented data stating that the amount of estrogen being released by the patch varies from women to women. The difference in the amount of released estrogen is causing the increased blood clots in its users, not to mention other painful side effects that may come up.

Sidney Wolfe, the head of the research group, stated in the petition letter that the various safety concerns regarding long term use of the patch and the variable estrogen exposure tips the balance of Ortho-Evra's risks and benefits against its reputation as a contraceptive.

During the time of its release, the FDA found the patch safe for women to use. However, when studies came out showing that women between the ages of 15 to 44 were more likely to develop blood clots while on the patch as compared to the birth control pill.

The birth control patch was said to have been created as a more convenient alternative to the birth control pill. But if were designed to be a birth control pill, this product would not have been approved based on the amount of estrogen it contains. Last year, roughly 2.7 million prescriptions have been written for the birth control patch, making it a part of the top 200 brand-name drugs in the United States. It only goes to show that a lot of people still think that the patch does not have much side effects.

The FDA explains that chances of developing a blood clot is low, with a ratio of 3 to 5 women out of every 10,000 patch users end up developing blood clots because of the contraceptive. The manufacturers reiterate by saying every hormonal birth control method in the market has their own set of side effects and benefits, theirs is no different.

Wolfe pointed out, though, that even if women were able to stick to the routine better when using the patch, the rate of accidental pregnancy while using the said contraceptive is just the same as it is with the birth control pill.


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