Johnson & Johnson and Ortho-McNeil's birth control patch "Ortho Evra" may increase a woman's risk of blood clots as it delivers extreme doses of estrogen.

Investigation and pending class action against Johnson & Johnson and Ortho-McNeil following claims that Ortho Evra birth-control patch may have caused blood clot problems and other serious side effects in users .In one instance, it is claimed the patch's effects were responsible for the death of a young women in December 2003 from multiple pulmonary emboli, or sudden arterial blockages in the lungs due to blood clots.

Medical monitoring is needed because it's just as important to screen patch users who haven't yet been adversely affected as it is to treat those who have. The Food & Drug Administration announced that the Ortho Evra patch delivers levels of estrogen about 60 percent higher than most daily birth-control pills, and that it can put patients at higher risk for blood clots. At the same time, the FDA approved updated labeling for the Ortho Evra patch to explain the potential risk.

Ortho-McNeil, a subsidiary of Johnson & Johnson, also posted a notice on its Web site. According to information on Johnson & Johnson's Web site, more than 5 million women have used the Ortho Evra patch. Johnson & Johnson also makes oral contraceptives such as Ortho Tri-Cyclen Lo. The company's 2005 annual report said its hormonal contraceptives accounted for $1.3 billion in 2004 sales.

Do not change medications without first consulting your doctor.