On November 10, 2005 Johnson & Johnson’s Ortho McNeil unit issued a warning that the Ortho Evra contraceptive patch contains higher levels of a hormone known to cause blood clots than average birth control pills. Women who use Ortho Evra are exposed to 60 percent more estrogen than those who use the pill, the FDA said in a statement. The warning comes after several investigative reports by The Associated Press and CBS News highlighted the risks of Ortho Evra.
The Associated Press reported that it appears that the risk of dying or suffering a survivable blood clot while using the Ortho Evra birth control patch was about three times higher than while using birth control pills. The AP found that the FDA and and Ortho-McNeil were aware of the increased risk of blood clots associated with the patch even before it was approved. According to FDA reports obtained by the Associated Press, a dozen women died last year from blood clots believed to be related to the Ortho Evra patch.
FDA records show that seventeen patch users between the ages of 17 and 30 have suffered fatal heart attacks, blood clots and possible strokes since August 2002. Blood clots are masses of thickened blood. Clotting is a means used by the body to end bleeding.
The first stage in clotting is adhesion of platelets, which are fragments of blood cells that travel in the blood, to the cut edges of a damaged blood vessel. As a result, a platelet plug is formed and external bleeding stops. Next, small molecules, called clotting factors, cause strands of materials, (fibrin) to stick together and seal the inside of the wound. Eventually, the cut blood vessel heals and the blood clot dissolves after a few days. A blood clot can become dangerous when it blocks an artery or vein and stops blood flow.
The blood clot is then called a thrombus. Although a thrombus may occur in any blood vessel, it most commonly develops in the veins of the leg and can travel through the major blood vessels of the pelvis and lung where it can be fatal. A thrombus in the leg or pelvic vein is called a deep vein thrombosis (DVT). A thrombus that breaks free and travels within the bloodstream it is called an embolus. As it travels, it compromises blood flow and may become lodged in a smaller blood vessel, causing blockage.
For example, if an embolus blocks an artery in the lung, it is called a pulmonary embolism. Common symptoms of a pulmonary embolus include: shortness of breath, chest pain and coughing up blood. Common signs of a DVT include: pain in the calf or leg muscle, swelling, tenderness, prominent veins and discoloration.
Less common symptoms may include: back , shoulder or upper abdomen pain; dizziness; fainting; painful respiration; wheezing; new heart arrhythmias. An embolism can also travel to the heart, eyes, or brain. An em-bolus in the brain can cause strokes. An em-bolus blocking an artery in the heart can cause heart attacks. An em-bolus may cause sudden blindness in one eye. An em-bolus that blocks an artery is a life- threatening condition. There are many factors that increase the risk of blood clots: Atypical Antipsychotic Drugs, HRT Drugs, Ortho Evra contraceptive patch, bed rest, chemotherapy, deep vein thrombosis, fractures, birth control pills, smoking and cancer.
Legal Help For Victims Affected By Blood Clots
If you or a loved one has taken HRT drugs, COX-II Inhibitors or used the Ortho Evra Patch and been diagnosed with Blood clots, please fill out the form at the right for a free case evaluation by a qualified defective drug attorney or call us at 1-800-YOURLAWYER (1-800-968-7529).