Health issues from birth control patch spark lawsuits from local women

Tuesday, January 31, 2006

Marketed to be as effective as the pill, Ortho Evra is the first skin patch approved by the FDA for birth control. But several months after Jackson resident Rachel Cook started using the patch last year, she experienced chest pains and was hospitalized for blood clots in her lungs.

"The doctor took me off the patch and told me the blood clot was because of the patch," said Cook, who was hospitalized twice more for blood clots.

Now Cook, 22, and a Cape Girardeau woman have filed lawsuits against Ortho-McNeil Pharmaceuticals, owned by Johnson and Johnson. The suit alleges that the women used the patch and suffered blood clots and other injuries as a result.

The FDA approved the patch in 2001 but last November updated its label to warn health-care providers and patients that it exposes women to higher levels of estrogen than most birth control pills. It warned users of an increased risk of blood clots, heart attacks and strokes.

The FDA warns that users of the patch are exposed to about 60 percent more estrogen in their blood than if they were taking a typical birth control pill, which contains 35 micrograms of estrogen, said Jennifer Gwin, nurse practitioner at Southeast Missouri State University's Center for Health and Counseling. But estrogen from the patch does not release into the body all at once; every 24 hours a certain dose of it is released.

"We do offer the patch at our clinic and because it is such a convenient method of contraception," Gwin said. Women who use the Ortho Evra patch can wear it for 5 days in a row, where the pill is taken every day.

Dr. Tami Williams, a Cape Girardeau gynecologist, said any time a woman has an increased estrogen level, it increases the risk of blood clots.

"The risks for the patch are really not that much higher than the risks of taking the pill," Williams said. "To be honest, I've never really been a big fan of the patch to begin with. It's not this cute little Band-Aid women can wear. It leaves a big, sticky black ring after 5 days."

Both Williams and Gwin have patients using the Ortho Evra patch and have not experienced any problems associated with the FDA's warning.

"There have been quite a few who have come in to the office to question its safety," Gwin said. "And there have been some who want to be taken off of the patch."

Patients who smoke will run a greater risk of blood clots when using the patch or taking the contraceptive pill.

Cook, who smokes, said she previously used birth control pills and never experienced any problems like she did while using the patch.

"My doctors thought since I was so young, I wouldn't really have any difficulties," Cook said. "I thought it would be easier to use but now I will have to be on blood thinners for the rest of my life because of it."

Tammy Overkamp, 33, of Cape Girardeau, is the other complainant in the suit. She could not be reached for comment.

Telephone calls to Ortho Evra's communications director were not returned on Monday.

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