The U.S. Food and Drug Administration (FDA) has approved additional changes to the Ortho Evra Contraceptive Transdermal (Skin) Patch label to include the results of a new epidemiology study that found that users of the birth control patch were at higher risk of developing serious blood clots, also known as venous thromboembolism (VTE), than women using birth control pills.
VTE can lead to pulmonary embolism.
The label changes are based on a study conducted by the Boston Collaborative Drug Surveillance Program (BCDSP) on behalf of Johnson and Johnson. The patch was studied in women aged 15-44. These recent findings support an earlier study that also said women in this group were at higher risk for VTE.
"For women that choose to use contraceptives, it is important that they thoroughly discuss with their health care providers the risks and benefits involved," said Janet Woodcock, M.D., the FDA's deputy commissioner for scientific and medical programs, chief medical officer, and acting director of the Center for Drug Evaluation and Research.
"This is an example of FDA working in tangent 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."
In September 2006, FDA revised the label for Ortho Evra to warn women of the risk of VTE based on two epidemiology studies. One study, conducted by i3 Ingenix, showed that some women using the patch were at a two-fold greater risk of developing VTE. The other study, conducted by BCDSP, showed they were not at increased risk compared to women using birth control pills containing 30-35 micrograms of estrogen and the progestin norgestimate.