ePillz.com - Ortho Evra Patch Received Stronger Warning from FDA

Ortho Evra Patch Received Stronger Warning from FDA

January 18, 2008

- Food and Drug Administration –

Ortho Evra, the only approved contraceptive in the form of a skin patch, received new label with stronger warning for all the women, using this form of contraception. The warning states that the use of Ortho Evra is associated with greater chances to develop blood clots, also known as venous thromboembolism (VTE), than the use of Ortho Tri Cyclen or other daily birth control pills.

In fact, the labeling information on Ortho Evra patch has already been once changed in regard to blood clots risks (see article Ortho Evra May Cause Blood Clots, dated September 20, 2006). However, at that time the decision of the U.S. Food and Drug Administration (FDA) was based on the data from two clinical studies with absolutely opposite results.

Recently, the FDA received results from new clinical trial conducted by the Boston Collaborative Drug Surveillance Program (BCDSP) on behalf of Johnson and Johnson, the manufacturer of Ortho Evra. New finding removed all the previous doubts and incompliance, and finally proved that there is definitely an increase of blood clots risks for those who use Ortho Evra patches.

"For women that choose to use contraceptives, it is important that they thoroughly discuss with their health care providers the risks and benefits involved," said Janet Woodcock, M.D., the FDA's deputy commissioner for scientific and medical programs, chief medical officer, and acting director of the Center for Drug Evaluation and Research.

Blood clots are considered to be among the most serious side effects, associated with the use of hormonal contraceptives, including Ortho Evra. Taking into account that the users of Ortho Evra receive much more (up to 55%) estrogen than the users of Ortho Tri Cyclen or other daily birth control pills, skin patch users are said to be in two-fold or even four-fold greater risks to develop blood clots in comparison with the daily pills users.

The newly approved label of Ortho Evra contains the list of warning signs, which may prompt a woman on the potential danger:

Sharp chest pain, coughing of blood, or sudden shortness of breath. (Such symptoms may indicate a possible clot in the lung.)
Pain in the calf. (This may be a sign of a possible clot in the leg).
Sudden partial or complete loss of vision. (Such symptom may indicate a possible clot in the eye).

In case of experiencing any of the mentioned symptoms a woman should seek medical help as soon as possible. Besides, to lower the risks of blood clots, Ortho Evra patches should be used strictly in accordance with label and doctor indications. Those, who are preparing for surgery, should stop using patches 2 weeks prior to operation. Women after delivery should avoid using Ortho Evra too.

Nick

External resources
http://www.fda.gov/bbs/topics/NEWS/2008/NEW01781.html
http://www.webmd.com/sex/birth-control/news/20080118/birth-control-patch-stro...
http://www.fda.gov/cder/foi/label/2008/021180s026lbl.pdf