Birth control patch higher risk than the pill, FDA saysDec 5, 2005 | The Daily Illini The Food and Drug Administration approved updated labeling for the Ortho Evra contraceptive patch in November.
Ortho-McNeil Pharmaceutical, Inc., the manufacturers of the contraceptive, now place a warning on the product indicating it contains higher levels of estrogen and progestin hormones than most birth control pills.
Women on Ortho Evra are exposed to 60 percent more estrogen than women taking a 35-microgram birth control pill, said David Lawrance, medical director at McKinley Health Center. Products with increased estrogen levels heighten the likelihood of blood clots and strokes for some women.
Denise Watkins, a nurse practitioner in the Women's Clinic at McKinley Health Center, said that Ortho Evra was marked originally as a 20-microgram dosage product.
"The labeling is being changed in order to make providers aware that it's not a 20-microgram dose method and to be aware that if you want a lower dosage method that it's not a good option," Watkins said.
Though the estrogen levels of Ortho Evra have proven to be higher, both Planned Parenthood and McKinley Health Center are not concerned about taking anybody off of the patch.
"Ortho Evra has just started being studied and checked for problems-as of now, no problems have been recorded in scientific literature," Lawrance said.
Kathie Spegal, director of community affairs at Planned Parenthood in Champaign, said that Ortho Evra users' health has been carefully evaluated and that the increased estrogen levels shouldn't cause health problems for users originally screened as Ortho Evra candidates.
Spegal said when screening the women, Planned Parenthood looks for specific risk factors that would make the women ineligible for Ortho Evra- regardless of the product's estrogen level.
The main risk factors are "being older than age 35, tobacco use, high blood pressure, diabetes, and high levels of cholesterol," Spegal said.
Watkins said that the McKinley Health Center is also very cautious about examining women's health.
"We're being cautious and give careful consideration to putting someone on a method," said Watkins.
Some factors considered during screening are menstrual history, high lipid profiles and family health history.
When it comes to Ortho Evra, McKinley sees no immediate apprehensions with current users but will discuss concerns and switch to pills if the patient desires. Women have to come in yearly for a screening examination to see if their health conditions have changed and if a different type of contraceptive is more fitting, Watkins said.
Ortho Evra's estrogen levels remain at a constant level compared to typical birth control pills, which allow the level to fluctuate, said Spegal. While on Ortho Evra, the patch is changed weekly for three weeks and releases the same levels of estrogen from day one to day seven. The fourth week is a "patch free" week.
"Ortho Evra maintains a higher level of estrogen in the body," Spegal said. "The hormone never drops off and stays at a constant level."
Women who take the pill must take it at the same time each day because the level of estrogen in the body decreases as the days go by.
Planned Parenthood carries all FDA forms of birth control. There are 560 women who have chosen the Ortho Evra patch as their birth control since January of 2005, Spegal said.