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Patch problems prompt warning

Ortho Evra birth control manufacturer changes safety info to tell users about increased estrogen absorption

Nov 16, 2005 | www.orion-online.net

Students using the Ortho Evra birth control patch will find a heightened warning in the safety information.

Ortho Women's Health, a unit of Ortho-McNeil Pharmaceutical Inc., changed the patch's warning label Thursday to inform consumers that women using the patch are exposed to more estrogen, which can increase the risk of side effects such as blood clots, stroke and heart attack, according to the company.

The new label says women who are using the patch are exposed to about 60 percent more estrogen than women using a typical birth control pill because hormones from the patch get into the bloodstream and are removed differently than hormones from birth control pills.

If students go to the Student Health Center for birth control, the employees will inform them patch users absorb more estrogen, but they won't discourage women from using the product, said Dr. Jeff Thomas, chief of clinical medicine at the center. The Student Health Center filled patch prescriptions for 390 women from November 2004 through Monday.

Thomas said the center would only discourage a patient from using the patch if she were elderly or a smoker. In these cases, employees would discourage the patient from using any type of hormonal birth control.

"I think most students can take it totally safely," Thomas said.

Luann Ciccone, director of Chico Planned Parenthood, said there have been a small number of deaths, but it isn't enough to discourage women from using the patch and increase their risk of becoming pregnant.

"We don't want to scare young, healthy women from using hormonal birth control," Ciccone said. "People aren't going to stop having sex. They're just going to stop using birth control."

Planned Parenthood isn't changing its medical policy because there is no proof patch users have a greater risk of serious side effects, Ciccone said. And Ortho-McNeil is a reputable company.

But according to a July story by The Associated Press, women in their early 20s and late teens have experienced serious side effects from the patch.

According to federal drug safety reports, a dozen women, most about 20 years old, died in 2004 from blood clots thought to be related to the patch, and dozens more survived strokes, according to the AP.

The reports showed that in 2004, women using the patch were three times more likely than birth control pill users to die or suffer a blood clot, according to the AP.

Ortho-McNeil spokeswoman Bonnie Jacobs declined to comment about the article but said the company isn't looking into the AP's reports because a newspaper compiled the information, and the company only looks at "actual data."

However, some attorneys are taking the data into consideration.


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