FDA urges users of Ortho Evra to discuss risks with their doctor
In response to the latest study coming out of the Boston Collaborative Drug Surveillance Program (BCDSP) the FDA is urging women who are currently using the Ortho Evra transdermal birth control patch to discuss with their doctors as soon as possible their risk to Venous Thromboembolism. Venous Thromboembolism or VTE is characterized by serious blood clots in a vein. At the sight of the clot, typically it will become painful, red and swollen and could partially or totally block blood flow. VTE occurs most often in the veins of the legs and pelvis and also the arms. If the clot or part of it breaks off and travels to the lungs and/or heart it is called a pulmonary embolism. Janet Woodcock, M.D., Deputy Commissioner for Scientific and Medical Programs, Chief Medical Officer, and acting director of the Center for Drug Evaluation and Research, said "For women that choose to use contraceptives, it is important that they thoroughly discuss with their health care providers the risks and benefits involved. This is an example of FDA working in tandem with the drug manufacturer to keep the public informed of new safety data and epidemiological studies that may impact health decisions about the use of FDA approved products."
