The United States Food and Drug Administration (FDA) has determined that the Ortho-Evra birth control path has a high risk of causing life threatening blood clots. In 2005 alone, about one dozen women died from blood clots believed to be related to the patch with dozens more surviving strokes and other clot-related problems. These women were largely young and not at risk for clots. Women like Zaklya Kennedy, an 18 year old Manhattan fashion student who collapsed and died in a NY subway station in April 2004, and Sasha Webber, a 25 year old mother of two who died of a heart attack after six weeks on the patch.
The Associated Press analyzed federal drug safety reports finding that women using the patch are at a triple risk of dying or suffering a survivable blood clot compared to women using birth control pills.
The FDA approved Ortho-Evra in November 2001 as the first birth control skin patch. But long before the patch reached the marketplace in 2002 both the FDA and Ortho McNeil, the Johnson & Johnson company that manufactures Ortho-Evra, saw warning signs of possible problems. The FDA had already noticed that nonfatal blood clots occurred three times more frequently than the pill. Blood clots in the lungs were seen in two women given Ortho-Evra in clinical trials conducted before the drug was approved – in addition to many similar cases in women after the drug was marketed. According to Public Citizen, drugs rarely present such strong evidence of a serious problem during randomized pre-approval studies.
Ortho-Evra contains two hormones: an estrogen and a progestin. Most pills and the patch contain the same amount of estrogen, but hormones from the patch go straight to the bloodstream while pills swallowed and digested lose half the estrogen dose. Women using the patch are exposed to high levels of estrogen 24 hours a day. Associate Professor of Obstetrics and Gynecology at the University of Washington, Dr. Leslie Miller has reported that women using the patch absorb significantly more estrogen than the pill, adding the elevated levels may be high enough to increase some women’s risk of blood clots.
On November 10th, the FDA updated labeling for the Ortho-Evra birth control patch to warn healthcare providers and patients that this product exposes women to higher levels of estrogen (about 60% more) than the pill. But not all physicians waited for the new label to take action. In October, Dr. Miguel Cano, an obstetrician and gynecologist in Reedley, California, sent a note to several thousand patients recommending that they stop using the patch and that they come in for appointments to get a new form of contraception. On the website, www.worstpills.com
Public Citizen proclaims: “There is no medical reason for women to use the more dangerous Ortho-Evra rather than one of the older, better understood, and equally effective oral contraceptives.” Public Citizen’s Health Research Group added Ortho-Evra to its ongoing list of dangerous medicines.
Catchy ads featuring Olympic beach volleyball players and supermodel Naomi Campbell resulted in more than five million US women trying the patch in less than three years. In 2004, Ortho-Evra sales topped $411 million for 9.9 million prescriptions, accounting for 15% of the US market. In July 2005, J&J CFO Robert J. Daretta reported no sign of increased safety problems with the birth control patch. Obviously, Mr. Daretta did not foresee the increased lable warnings.
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