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Birth control patch could pose unforeseen health problems

Nov 17, 2005 |

Michaela Smart has plenty of advice when it comes to birth control and blood clots.

“Don’t smoke,” the senior special education major at the University of Nebraska at Omaha said. “Get tested for all clotting diseases.”

Smart is part of a growing number of women, health care providers and prescription drug officials paying attention to health risks related to birth control use.

The Food and Drug Administration issued a warning last week that users of the Ortha Evra birth control patch are at a higher risk for blood clots and other serious side effects.

Ortho-McNeil, Inc., the maker of Ortho Evra, issued a report following the FDA’s warning, saying women using the patch will be exposed to about 60 percent more estrogen than those using typical birth-control pills. This is because hormones from patches enter the bloodstream and leave the body differently than the hormones from pills.

Users of Ortho Evra apply a new patch once a week for three consecutive weeks each month, going patch-free for the fourth week during their periods.

In July 2002, 20-year-old Smart visited a physician’s assistant about her irregular period.

Smart was prescribed the Ortho Evra birth control patch, but after using it for only three weeks, she knew something was wrong.

“I had a pain in my hip,” she said. “I dragged myself up the stairs ... My right leg was twice the size of my left one and purple.”

She called the hospital and was eventually diagnosed with a blood clot running from her belly button to her right ankle.

Smart was on bed rest for two weeks at home before spending four days in the hospital’s intensive care unit undergoing a procedure involving a catheter and blood thinners.

Smart’s family had no history of blood clotting problems. After further testing, doctors determined she had a genetic disorder called hyperhomocysteinemia, which increases the risk of blood clots.

Smart had gone 20 years without any problems until she started using the Ortho Evra patch.

“Right away, the nurses told me to rip the patch off,” she said.

Now, three years later, Smart’s blood clot is virtually gone. However, she’ll be feeling the effects for the rest of her life.

Smart still wears a support stocking on her entire right leg to help with blood flow. She has had veins collapse in both her hip and her calf areas. Her irregular periods continue. She underwent a hysterectomy at the age of 23.

Four months prior to the FDA warning, The Associated Press reported that the Ortho Evra patch causes users to suffer blood clots and die at a rate three times higher than women who are taking Ortho-Cyclen birth control pills.

The report also stated that about a dozen women died in 2004 from blood clots believed to be related to the birth control patch.

Effie Delimarkos of Ortho Women’s Health and Urology, a division of Ortho-McNeil, said she was not familiar with The Associated Press report.

University Health Center officials at the University of Nebraska-Lincoln are aware that numerous women on campus are currently using the Ortho Evra patch.

“We are definitely discussing the new findings (with patients),” said Dr. Joseph Hermsen of the health center.

Hermsen admits he has never “been a fan” of the patch because it doesn't always stick to the patient. And in light of the study, he said he would not recommend the product.

Bobbie Kierstead, vice president of public affairs for Planned Parenthood of Nebraska, said users of the patch should be cautious.

“There are certain risk factors, and women who have these risk factors stand a greater chance of developing health problems,” she said.

People who are older than 35, have diabetes, use tobacco or have high blood pressure are more at risk for complications.

Planned Parenthood officials want their patients to be fully knowledgeable about any medications they are currently taking, Kierstead said.

“We will be discussing the findings of the study when patients come in for their regular checkups,” she said.

Smart said she regrets her decision to use the patch, and said she wished she had known more about its dangerous side effects.

Because of complications, Smart is unable to have children and couldn’t traditionally celebrate her 21st birthday because of blood-thinning medication.

“If I had known I was more likely to get a blood clot, I would never have got on (the patch),” she said. “It’s totally changed my life.”

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