ePillz.com - Ortho Evra May Cause Blood Clots

Ortho Evra May Cause Blood Clots

September 20, 2006 - Food and Drug Administration –

The American Food and Drug Administration (FDA) reported in its press-release about the update of labeling information for Ortho Evra, the only contraceptive patch, available on the US market for the time being. It is the safety profile of the popular birth control method that has been revised and amended with new data, saying that women, using Ortho Evra, are in greater risk to develop blood clots, than those, who use daily birth control pills.

Formation of blood clots belongs to serious side effects, which can be potentially caused by some medications. In fact, building blood clots is a normal body response to the injury of blood vessels. This is one of the self-defense means of the human body. However, there is a condition in medicine, called thromboembolism, when blood clots, formed elsewhere in the body, block blood vessel, thus interfering with the normal bloodstream. Sometimes this condition may be caused by certain medications, which can lead to such adverse reaction.

Investigation of the possible connection between Ortho Evra contraceptive patch and blood clots risk was initially based on several reports to the FDA, suggesting that Ortho Evra has the greater risk for venous thromboembolism, compared to oral contraceptives.

As the result two studies were initiated to evaluate the potential of Ortho Evra in causing the formation of blood clots. The studies were conducted by two different groups of scientists. It is a surprising fact, but the findings from these two studies are absolutely opposite. One group of scientists found that the risk of developing blood clots as the result of Ortho Evra usage was similar to the risk, associated with traditional birth control pills. At the same time, the other group showed that there is a 2-fold increase in the risk of medically verified thromboembolism events in users of Ortho Evra compared to the users of oral contraceptives, based on the same working ingredients.

In spite of the contradiction between data from two studies, FDA and the manufacturer of Ortho Evra patches decided to include appropriate information to the product labeling. All the women, who are predisposed to develop thromboembolism, are recommended now to consult a doctor in order to make the right choice between Ortho Evra patches and daily birth control pills.

Finally, it is interesting to note that the mentioned studies evaluated not only risks of blood clots, associated with Ortho Evra, but also the potential of this contraceptive to cause heart attack and stroke. Unlike the results with blood clots, two studies were solidary in stating that the chances to develop heart attack or stroke under the influence of Ortho Evra are similar to the chances of experiencing these conditions, caused by birth control pills usage.

About Ortho Evra Ortho Evra, approved by the FDA in 2001, is now one of the most popular birth control methods. It is made in the form of patch, which should be attached to the skin only once a week. Three weeks with patches are followed with the patch-free week. Thus, Ortho Evra offers women a new level of convenience with birth control, eliminating the necessity to take pills accurately every day at the same time. Ortho Evra, when applied to skin, releases small amounts of progestin and estrogen, preventing the ovulation and making pregnancy impossible. In general, Ortho Evra works similar to traditional contraceptive pills; the difference is only in the form of medication and in the way it is used by a woman.

Nick

External resources
http://www.fda.gov/cder/drug/infopage/orthoevra/qa20060920.htm
http://www.orthoevra.com/html/pevr/media_statement.jsp?
http://www.orthoevra.com/html/pevr/newsroom_press_02162006.jsp?