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More Ortho Evra® News
Ortho Evra®, according to medical experts, can become unsafe when heated by exercise, bathing in a hot tub, or by a high fever. "Most people don't realize that heat is going to increase absorption rates, even to toxic levels," stated Michael Cohen, director of the Institute for Safe Medication Practices, an industry watchdog.
Recently the Food and Drug Administration (FDA) announced it was launching a comprehensive review of the safety of the patches. Part of the review specifically studies how heat affects the different patch drugs.
The FDA investigation comes eight months after they launched a probe into 120 deaths linked to fentanyl patches, which are used for chronic pain. In November 2005, the FDA issued a warning about Ortho Evra® birth control patches after a study showed that women who used the patch had 60 percent more estrogen in their blood than those on a traditional birth control pill.
In the last 25 years, patch medications have increased in its uses from a motion-sickness drug to more than 30 prescription patches used by over 12 million people worldwide.
Experts say that heat increases the absorption rate on all patches because patches work in the same way. The drug soaks through the skin into the bloodstream, and increased blood flow causes the body to absorb the drug faster, says Bozena B. Michniak, who studies transdermal patch delivery at the Center for Biomaterials at Rutgers University.
But not all hot patches will necessarily cause harm.
"It depends on the drug and the patch," Michniak said. "We could all say there will be an effect and absorption rate will increase, but how much? Many factors play a role."
FDA officials say that as few as 1 percent of all serious side effects are reported. The FDA's database does not give details about the exact cause of death.
In 2004, patches overall were cited as the primary cause of death in eight cases, including two teens on Ortho Evra® birth control patches, according to an analysis of an FDA database.
"The problems are real, they're happening and they're underreported," said Cohen, who sits on the FDA's Drug Safety and Risk Management Advisory Committee. "It's possible for people to get hurt."
Studies in 1986 showed that heat can double the rate at which the body absorbs medication, but there were no public warnings until 1994. The warnings came after the death of a 36-year-old Montgomery County man. He fell asleep with a heating pad on while he was on a fentanyl pain patch for a back injury and never woke up.
Lucinda Buhse, director of the FDA's Division of Pharmaceutical Analysis, said that in December 2004, the FDA began a study to research how heat affects the absorption rates of all patches under various circumstances.
The investigation will focus on fentanyl and Ortho Evra® birth control patches first, to see how they react to hot tub and sauna heat, among other scenarios.
Douglas Stokke, a spokesman for Johnson & Johnson, which makes the fentanyl patch and Ortho Evra® birth control patch, said the company did not have clear information about the FDA study.
One patch whose safety is being questioned is Ortho Evra®. Last year, doctors wrote more than 9.4 million prescriptions for it, according to IMS Health, an industry monitoring firm.
In November 2004, the FDA released a study saying that women who wore the patch had far more estrogen in their bloodstream than those who took a traditional birth control pill. Researchers are not sure why. Four months later, Johnson & Johnson released a study stating that women who wore the patch had twice the number of blood clots, which can cause fatal strokes and heart attacks.
Since July 2004, more than 40 lawsuits have been filed nationwide, claiming that blood clots caused by Ortho Evra® killed or injured women.
Reference:
"Experts: Patches + Heat = Danger" Philly.com, Dawn Fallik, March 2006.
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