Should Birth Control Patches be Discontinued?

The news is beginning to look worse for the contraceptive birth control patch Ortho Evra, and soon we may find it pulled from pharmacy shelves. A consumer advocacy group says the controversial patch, made by Johnson and Johnson, is too dangerous to still be on the market. Public Citizen is asking the federal regulators to discontinue Ortho Evra because there is a higher risk factor over other forms of contraceptives. for potentially fatal blood clots.

When Ortho Evra first came to the market in 2002, Johnson and Johnson spoke highly of the once weekly patch because it was an easy and convenient alternative to taking a pill every day. The safety label on the package originally stated that the patch's health risks were very similar to those of the pills. The Food and Drug Administration (FDA) warned women in 2005 that those who were using the patch were exposed to approximately 60 percent more estrogen than the women who were using the oral contraceptives. It is believed that the difference in the hormone level is due to how the medicine is being delivered into the body. The pills are partially diluted due to the digestive system, where as the patch delivers the medication straight into the blood stream, which causes a higher concentration of the medication to the person's whole body. The higher levels of estrogen can greatly increase the risk of a patient developing blood clots, strokes, heart attacks, or other serious injuries.

Up until November 2005, the Food and Drug Administration received twenty-one reports of blood clots that were life threatening and other illnesses that were associated with the use of the Ortho Evra patch. A study was published in 2006 that shown women that were using the patch were twice as likely to suffer a type of blood clot that is called venous thromboembolisms (VTEs), which is a clot that can travel to the lungs and cause a fatal pulmonary embolism, as compared to those women that were taking the pill. The study prompted the FDA to request a change on the label for the patches to include stronger safety warnings. This past January, the Food and Drug Administration asked Ortho Evra to once again change their label to include information on yet another study that found the patch doubles the risk of developing VTEs compared to oral contraceptives.

Now, The Health Research Group of Public Citizen filed a petition with the Food and Drug Administration asking that the patch Ortho Evra be removed from the market completely. The petition stated that the amount of estrogen released from the patch varies widely among women. "The considerable safety concern of high-dose, variable estrogen exposure tips the balance of risks and benefits against the availability of Ortho Evra as a contraceptive," wrote the head of the research group Sidney Wolf.

The Ortho Evra patch has been named in over 2,000 lawsuits since 2006. As the lawsuits have made their way through the court system, there has been evidence presented that Johnson and Johnson knew long before the FDA or the public about the increased risk of blood clots associated with the patches.

So is this the end for the patch? The Food and Drug Administration has not responded yet to the petition, so the jury is still out.