The labeling on the Ortho Evra transdermal patch to better communicate the risk of blood clotting from use of the medication. The FDA had already officially concluded that there was an increased risk of blood clots associated with use of Ortho Evra, but the new labeling went a step further by displaying a chart of data of the results of several recent studies. The labeling change was a concerted decision by the FDA to inform patients and physicians about the increased blood clotting risks of Ortho Evra without having to go so far as to remove the contraceptive from the market (the benefits outweighed the risks).
The Risk of Blood Clots
Ortho Evra modulates estrogen levels for birth control purposes (increasing estrogen levels by nearly 60% compared to oral contraceptives). It's important to note that estrogen itself promotes blood coagulation. Thus, when some women use Ortho Evra, there is a significantly higher risk of forming unhealthy blood clots.
Blood clots generally begin in the leg and can be especially dangerous if they travel to cores systems such as the heart, lungs, or brain, and stroke, heart attack, or even death may result from major blockages created by these blood clots. Blood clots present in a number of different ways, but there are several critical signs that women on Ortho Evra should look out for.
Indicators of a Serious Problem Requiring Immediate Medical Attention
The warning signs of Ortho Evra induced blood clotting include:
1. Crushing chest pain or tightness in the chest. This is a sign of a heart attack, possibly as a result of blood clotting.
2. Sharp chest pain, coughing of blood, sudden shortness of breath. This is a sign of a possible blood clot in the lungs.
3. Sudden and severe headache or vomiting, dizziness, fainting, disturbances in vision or speech, weakness or numbness in an arm or leg. This is a sign that the person has suffered a stroke.
4. Sudden loss of vision (partial/complete). This is a sign that a blood clot has formed in the eye.
Unfortunately, by the time a woman experiences these side effects, the reality is that a serious problem involving traveling blood clots may already exist. Ortho Evra patch users should therefore not wait until they see these effects before speaking to their doctors about the risk of blood clotting. In fact, the FDA recommends that women speak with their doctor beforehand to determine whether the Ortho Evra birth control patch will be a safe method of contraception for them, given their existing clinical profile.
Suffering from Clood Clotting Symptoms?
All women using Ortho Evra should work closely with their doctor to monitor their health to and make absolutely sure that the negative side effects do not materialize. If blood clotting symptoms appear, get medical help immediately and cease use of the patch.
If you were injured by your use of Ortho Evra, and you feel that your doctor may have prescribed Ortho Evra to you without properly communicating the risks, without monitoring your progression on the patch, and/or without correctly analyzing your clinical profile, then you should contact a qualified local attorney to see if you can build a case against your doctor for medical malpractice. For example, if you are over 35 years old and a smoker, then Ortho Evra should not have been prescribed to you for use. If it was, then your doctor breached his or her reasonable standard of care.
Alternatively, your injuries may justify a case against the manufacturer of Ortho Evra for product liability -- but these are strategies that should be discussed with your attorney in more detail. If you do not have an attorney, and think you need one, you can search FindLaw's directory for experienced product liability attorneys.
Due to the increased risk of blood clotting and the negative health events associated with such clotting, some public organizations and doctors strongly believe that women should not use the Ortho Evra patch. Public Citizen, a consumer watchdog group, says there is no medical reason for women to use the newer, more dangerous Ortho Evra as opposed to older, better understood, and equally effective oral contraceptives.
Contact a qualified product liability attorney to make sure your rights are protected.