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Fatal side effects land patch in court

Feb 13, 2006 | www.statenews.com

The contraceptive Ortho Evra is the focus of several lawsuits after causing severe side effects or death across the country.

About 60 individual federal and state suits have been filed, said a Missouri attorney. College-age women and younger using the birth control skin patch are having strokes and blood clots, sometimes leading to death, the attorney said.

Pulmonary embolism is the sudden blockage of an artery located in the lung, usually resulting from a clot that formed in the leg, according to the National Heart, Lung, and Blood Institute.

Other side effects can include skin irritation, nausea, heart attacks and some cancers.

In 2004, an eighth-grader in Wisconsin died from blood clots after using Ortho Evra for about eight weeks, Schlichter said.

Ortho-McNeil Pharmaceuticals spokesperson Effie Delimarkos declined to comment on pending lawsuits.

Marketed as the first FDA-approved birth control skin patch, Ortho Evra exposes women to 60 percent more estrogen than the pill, which could increase the side effects of blood clots, heart attack and stroke.

On Nov. 10, the U.S. Food and Drug Administration updated Ortho Evra's warning section and made label changes explaining the increased hormonal exposure. About 5 million women have used Ortho Evra since its release in 2002.

Ortho Evra combines two hormones, progestin and estrogen to deliver hormones through the skin and into the bloodstream over the period of a week, said Olin Health Center health educator Nicolle Stec.

Other types of hormonal contraceptives use lower concentrations of hormones released through the body, she said.

"The hormones flow directly into the bloodstream and are absorbed by the body differently than hormones from birth control pills taken by mouth," Stec said.

Ortho Evra patches are worn for three consecutive weeks each month on the shoulder, back, upper outer arm or butt, she said.

Like oral contraceptives, it is 99 percent effective against pregnancy but does not protect against sexually transmitted infections.

"If you are on any particular medication there is a risk for some sort of side effect," Stec said.

Since September, Olin has prescribed 679 Ortho Evra one-month supplies to women on campus, a majority to students, said Olin communications officer Kathi Braunlich.

Hospitality business senior Anna Heppler chose Ortho Evra because of its convenience and isn't afraid of the severe side effects.

"I did some research on it and decided it was the best option for me," Heppler said. "I wouldn't remember taking the pill everyday, and the patch is easy enough to change once a week."

Heppler said she has not experienced any side effects.

Women using Ortho Evra are advised not to smoke or drink alcohol because it can increase the risk of side effects, Stec said.


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