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Inquiry by FDA looks into risks of birth control

Nov 22, 2005 | The Temple News The FDA has approved a measure to update warning labels for the Ortho Evra contraceptive patch because of potential risks related to increased estrogen exposure.

The action, taken on Nov. 10, followed an analysis by the FDA and Ortho McNeil Pharmaceuticals to compare estrogen and progestin hormones in the birth control patch Ortho Evra to typical birth control pills.

Ortho Evra is the first weekly form of birth control, according to Ortho McNeil Pharmaceutical, the makers of the patch. Unlike birth control pills, which are taken every day at a certain time, the patch is applied once a week for three consecutive weeks, and then removed for the fourth week of a woman's menstrual cycle.

The Ortho Evra label now advises women who are taking, or considering using the patch, to consult their health care providers about potential risks related to increased estrogen exposure. Ortho Evra exposes women to 60 percent more estrogen than a typical birth control pill that contains 35 micrograms of estrogen.

When wearing Ortho Evra, hormones are steadily released into a woman's bloodstream throughout the day, for a period of seven days, according to Ortho McNeil Pharmaceutical.

Women are exposed to 60 percent more estrogen when wearing the patch because it is absorbed directly into the bloodstream. The pill travels through the digestive track and then is absorbed into the bloodstream, which causes half of the dose of estrogen to be lost, according to Dr. Abigail Wols, an instructor at Thomas Jefferson Medical College.

Increased estrogen exposure may increase the risk of blood clots, according to the FDA. However, it is unknown whether using Ortho Evra puts women at a greater risk of experiencing harmful affects.

Temple Student Health Services does offer Ortho Evra to students, according to Assistant Administrative Director Mark Denys.

SHS is a member of the Family Planning Council of Southeastern Pennsylvania.

"Being a family planning site allows us to offer many gynecological services including birth control at very low costs to students," Denys said.

Denys is unsure whether Temple will continue to offer Ortho Evra to students, but there are no plans to discontinue distribution at this time.

"One of the limitations of providing services in this manner is that we receive our birth control medications from them," Denys said. "If for some reason they are unable to give us a certain medication, then we are unable to offer it to the students."

A medical committee of the FPC will be reviewing the current information on Ortho Evra. In conjunction with the FDA, the FPC will make any appropriate recommendations, according to Denys.

"We will follow any recommendations that are made," Denys said.

Deaths from blood clotting, strokes and heart attacks occurred in women who were users of the Ortho Evra patch. It is not procedure to test patients for a history of blood clotting before prescribing birth control, according to Wols.

"Death compared to convenience? I'd rather set a daily reminder," said Kerry Bowman, a senior marketing major. "I know a lot of females who won't use the patch."

"It is unusual to test, partly because birth control is so safe, and partly because the genetic disorder that causes blood clotting is so rare," Wols said. "The risks of this are very small compared to pregnancy. It is something women should discuss with their health care provider."

Specific risks are found in different populations, according to Wols. Women should not use Ortho Evra if they smoke, have a clotting disorder, a family history of heart attack or stroke, high cholesterol or diabetes, or cancer of the breast or reproductive organs.

Sudden appearances of redness, swelling, or pain in the leg or calf are symptoms of blood clotting. Blood clotting in the leg can move up to the lung, causing sharp chest pains, coughing, and an increased heartbeat, according to Wols.

The makers of the Ortho Evra patch claim it is as effective as the pill, but a simpler birth control option.

Dr. Abigail Wols does not plan on advising any of her patients to stop using Ortho Evra. However, she does advise women who are or plan on using Ortho Evra, to consult their doctors first.

The FDA will continue to monitor safety reports for the Ortho Evra patch. Ortho McNeil Pharmaceuticals is conducting additional studies to compare the risks of using Ortho Evra to the risks of typical birth control pills.

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