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.

The new label was approved based on a study on women aged 15 to 44 by the Boston Collaborative Drug Surveillance Program on behalf of Johnson and Johnson, makers of the patch.

Ortho Evra is a safe and effective method of contraception when used according to the labeling, the FDA said in the statement, adding that women should consult doctors about using the patch instead of other birth control methods.