By Katrina Woznicki , MedPage Today Staff Writer – Reviewed by Zalman S. Agus, MD; Emeritus Professor at the University of Pennsylvania School of Medicine. – Source News Article: LA Times (Registration Req.), MSNBC, Washington Post (Registration Req.)
• For patients who want to use hormonal contraceptives, discuss their medical histories, especially conditions such as heart disease, hypertension, stroke, blood clots, and also whether they smoke.
• Inform patients that the risk of a blood clot or stroke when using hormonal contraceptives is small and there is little evidence that current low dose preparations are associated with increased risk in healthy women under the age of 35 without risk factors.
RARITAN, N.J., July 19-Ortho-McNeil is questioning the significance of a press report suggesting that the transdermal contraceptive patch Ortho Evra is riskier than an oral contraceptive.
The press report was derived from FDA data obtained under the Freedom of Information Act by the Associated Press. The raw data indicated that about a dozen young women who had used the transdermal contraceptive patch Ortho Evra died last year from blood clots.
Moreover, said the FDA data, dozens of young women survived strokes and other clot conditions after using the birth-control patch.
The FDA provided the news service with a database containing 16,000 different adverse events associated with Ortho Evra, ranging from mild rashes to deaths, with many duplicate reports. The news service interpreted the data to show that the risk of dying from a blood clot, or morbidity from one, is about three times higher when using the patch than with using an oral contraceptive.
Nevertheless, the patch’s maker, and some experts who question the statistics and their interpretation, say the patch is as safe as the Pill. The FDA, which approved Ortho Evra in November 2001, has said the patch is safe. The agency did not return calls for comment.
Ortho-McNeil here said it did not have adverse events figures available, but called the data quoted in the Associated Press report “misleading” because they are based on spontaneous reports — those called in voluntarily.
“Spontaneous reports can come from various sources and there is a significant amount of uncertainty regarding the validity of the information,” said Katherine LaGuardia, M.D., director of medical affairs at Ortho Women’s Health, the division of Ortho-McNeil that makes and markets the patch.
Ortho-McNeil also questioned the news agency’s denominator, saying that industry data show two million women used Ortho Evra in 2004, not the 800,000 that was claimed.
Reports of teens and women in their 20s who died after using the patch “is of a concern to us,” said Yvonne S. Thornton, M.D., a professor of obstetrics and gynecology at Weill Medical College of Cornell University in New York. In terms of hormone dosages, “what’s delivered is supposed to be the same” as those found in oral contraceptives, she said. “But because it’s a new delivery system, we don’t know.” It’s possible, Dr. Thornton said, that the quicker dose delivery from the patch might make the drug more potent.
Alan DeCherney, M.D., editor-in-chief of Fertility and Sterility and a professor of obstetrics and gynecology at the University of California, Los Angeles, said that although the number of adverse events may seem surprising, there is no cause for alarm.
“I don’t think Ortho Evra is any different from any other contraceptive,” he said. By the time a product reaches the market, he said, it’s typically been studied for five to 10 years and has proven safety and effectiveness.
Dr. LaGuardia said there is no evidence of a causal relationship, and there were no fatal events during clinical trials involving 3,300 women. “The types of adverse-event reports that have been received for Ortho Evra are consistent with the health risks of other hormonal birth control methods and the Ortho Evra label,” she said.
The company has cautioned that the patch should not be used by women who have the typical risk factors for cardiovascular disease, such as smoking, a history of heart attack, stroke or clotting disorders. It is not known whether the women who died after using Ortho Evra had been smokers or had any of the risk factors.
The patch releases 150 mcg of norelgestromin and 20 mcg of ethinyl estradiol into the bloodstream per 24 hours. It is changed once a week for three weeks; the fourth week the woman goes patch-free, and after that the regimen is repeated.
Dosages at this level are not high enough to warrant a significant risk of blood clotting or stroke among young people, said Lawrence Brass, M.D., a professor of neurology at Yale University and a spokesman for the American Stroke Association.
“With the current generation of low-dose contraceptives, there’s now debate about whether there’s any increased risk,” Dr. Brass said in an interview. “With the current generation of hormonal contraceptives, the risk of having a stroke is actually less than the risk of dying from child birth. So we’re talking about a very small risk.”
It is also possible, he said, that some young women who use hormonal contraceptives, including the patch, may unknowingly be genetically predisposed to clotting conditions. For example, they might carry factor V Leiden, the most common hereditary coagulation disorder in the U.S., affecting up to 5% of Caucasians and 1.2% of African-Americans.
However, conducting blood tests to screen those who might be at risk for clotting problems that could potentially be exacerbated by hormonal contraceptives isn’t feasible, Dr. Brass said.
According to the American Stroke Association, the prevalence of stroke among women in the U.S., ages 20 to 34, is 0.3%. For men, that figure is 0.4%. Subarachnoid hemorrhagic is one of the most common strokes among young people, Dr. Brass said.
“It’s a problem that’s very difficult to study,” he said. Premature death and blood clotting problems among young women using hormonal contraceptives “is a very rare event.”
FDA Calls Today Sponge Worthy to be Sold http://www.medpagetoday.com/OBGYN/Pregnancy/tb1/932
Continuous Use of Contraceptive Patch a Remedy for Withdrawal Headaches http://www.medpagetoday.com/OBGYN/HRT/tb1/1164
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The above is for general informational purposes only. Always consult your physician regarding specific medical issues and call Hatzalah or your local ambulance service in the event of an emergency.