Women are at higher risk of developing venous thromboembolism (VTE) when using the Ortho Evra Contraceptive Transdermal Patch, according to a new label approved by the U.S. Food and Drug Administration (FDA) on Friday.

VTE can lead to pulmonary embolism, the FDA said.

The prescription patch releases ethinyl estradiol (an estrogen hormone) and norelgestromin (a progestin hormone) through the skin into the blood stream

A series of lawsuits filed Wednesday on behalf of over 40 women claims a popular birth-control patch caused serious illness and one death. The sum sought by the plaintiffs is undisclosed.

The manufacturer, Ortho-McNeil Pharmaceutical Co., and distributor, McKesson Corp. of the Food and Drug Administration approved contraceptive are named as defendants

Ortho McNeil, makers of the popular birth-control patch Ortho Evra, are now warning millions of women that the patch exposes them to significantly higher doses of hormones, putting them at greater risk for blood clots and other serious side effects