Drug regulators in the United States have granted approval for an additional warning to be added to the label of a popular contraceptive patch.
The Ortho Evra Contraceptive Transdermal (Skin) Patch, will in future carry a warning of an increased risk of blood clots following links to serious blood clots in women who apply it.
Such blood clots, also known as venous thromboembolism (VTE), can lead to pulmonary embolism.
Ortho Evra is a prescription patch that releases ethinyl estradiol (an estrogen hormone) and norelgestromin (a progestin hormone) through the skin into the blood stream; it is applied once a week.
In a study conducted by the Boston Collaborative Drug Surveillance Program (BCDSP) it was found that women aged 15-44 who use the patch expose themselves to 60% more estrogen.
Typical birth control pills contain 35 micrograms of estrogen.
The findings support an earlier study that also said women in this group were at higher risk for VTE and previous labels warned of an increased risk of blood clots.
The FDA says women that choose to use contraceptives must discuss with their health care provider the risks and benefits involved.
The FDA says that Ortho Evra is a safe and effective method of contraception when used according to the labeling, which recommends that women with concerns or risk factors for serious blood clots talk with their health care provider about using Ortho Evra versus other contraceptive options.
The Ortho Evra Contraceptive Transdermal Patch is manufactured by Ortho McNeil Pharmaceuticals, a division of Johnson and Johnson who funded the research.