Federal health officials approved the sale of the world's first contraceptive patch in November 2001.
Ortho-Evra emits through the skin low doses of the same hormones used in birth control pills — but requires women to remember to use it weekly, instead of daily like a pill.
It may not work as well for women who weigh more than 198 pounds. Manufacturer Ortho-McNeil Pharmaceuticals said the patch would begin selling in 2002, by prescription only. The price will be similar to birth control pills, which cost about $40 a month. Risks may include irritation at patch site.
Otherwise, the same as birth control pills: short-term side effects such as nausea and breast tenderness; rare risks of blood clots, heart attack and stroke, especially among smokers. The long-term effects of these hormones on the body, especially when begun as a teenager, are still not fully understood.
In clinical trials that gave 3,319 women the patch for varying lengths of time, 15 got pregnant. It will begin selling next year. In studies, about 5 percent of women had at least one patch that slipped off. The patch delivers continuous low levels of estrogen and progestin, the same hormones found in birth control pills, to prevent ovulation.
The main action of the Patch is to inhibit ovulation, alter the cervical mucus, and to alter the uterine endometrium. This third action could cause the early abortion of a human embryo attempting to implant in the endometrium. [2001]
Fatalities Blamed On Birth Control Patch
Kathleen T's family gathered around her in the intensive care unit… The 25-year-old mother of three died last fall after days of agonizing headaches that the coroner's report said were brought on by hormones released into her system by Ortho Evra, a birth control patch she had started using a few weeks earlier.
She was among about a dozen women, most in their late teens and early 20s, who died last year from blood clots believed to be related to the birth control patch. Dozens more survived strokes and other clot-related problems, according to federal drug safety reports obtained by The Associated Press
under a Freedom of Information Act request.
under a Freedom of Information Act request.
Several lawsuits have already been filed by families of women who died or suffered blood clots while using the patch, and lawyers said more are planned.
Though the Food and Drug Administration and patch-maker Ortho McNeil saw warning signs of possible problems with the patch well before it reached the market, both maintain that the patch is as safe as the pill.
However, the reports obtained by the AP appear to indicate that in 2004 — when 800,000 women were on the patch — the risk of dying or suffering a survivable blood clot while using the device was about three times higher than while using birth control pills.
The women who died were young and apparently at low risk for clots — women like Zakiya Kennedy, an 18-year-old Manhattan fashion student who collapsed and died in a New York subway station last April. Or Sasha Webber, a 25-year-old mother of two from Baychester, N.Y., who died of a heart attack after six weeks on the patch last March.
Some doctors, reviewing the Food and Drug Administration reports at the request of The AP, were alarmed. "I was shocked," said Dr. Alan DeCherney, editor-in-chief of Fertility and Sterility and a UCLA professor of obstetrics and gynecology.
But other doctors said they would have expected some deaths and no investigation is warranted. They point to more than 4 million women who have safely used the patch and note that the FDA reports are called in voluntarily, rather than gathered scientifically.
"It doesn't jump out at me to say, 'Let's look at this any further,"' agreed Dr. Steven J. Sondheimer, professor of obstetrics and gynecology at the University of Pennsylvania. "I don't feel that these need to be looked at in any detail."
Ortho McNeil, a subsidiary of Johnson & Johnson, says none of the deaths can be directly attributed to the patch.
"Although we are investigating each and every one of the reports that we get, we have not drawn any causal relationships to the medication," said Dr. Katherine LaGuardia [Ortho McNeil's director of women's health care].
Blood clots are an accepted risk from hormonal birth control because estrogen promotes blood coagulation.
But how many clots are too many?
The AP found that before the patch was approved, the FDA had already noticed nonfatal blood clots from the patch were three times that of the pill.
The AP then examined what has actually happened since the patch came on the market and found that deaths also appear to be at least three times as high.
If you are a woman taking the pill who doesn't smoke and is under 35, the chance that you are going to have a blood clot that doesn't kill you is between 1 and 3 in 10,000. Your risk of dying from a blood clot while using the pill is about 1 in 200,000.
By contrast, with the patch, the rate of nonfatal blood clots was about 12 of 10,000 users during the clinical trials, while the rate of deaths appears to be 3 of 200,000.
Clots usually form in the legs, and become serious problems if they travel to a woman's heart, lungs or brain.
In 2000, doctors at the FDA reviewing clinical trials of the wafer-thin, plastic patch warned that blood clots could be a problem if it was approved.
In those trials, two of the 3,300 women using the patch were treated for blood clots that traveled to their lungs. Ortho McNeil says one of those women shouldn't be counted because she had undergone surgery. But an FDA reviewer, using capital letters and underscoring his comments, took issue with Ortho McNeil.
"THE REVIEWER DOES NOT AGREE WITH THE SPONSOR'S ABOVE CONCLUSIONS. The two cases of pulmonary embolus, a serious and potentially fatal condition, must be counted as two cases …," said the report. "The incidence rates quoted by the sponsor may be misleading."
The reviewer said "the label should clearly reflect this reviewer's safety concern about a potential increased risk." It would be important to study users after the patch came on the market for clot problems, he wrote.
But when the patch was approved in the U.S. in 2001, there were no requirements for follow-up studies beyond routine FDA reviews of reports called in by consumers, doctors and manufacturers.
The label's safety warning says two different and seemingly contradictory things: First, it says the patch is expected to be associated with similar risks as the pill. Then, it says it is unknown if the risk of blood clots from the patch is different from the pill.
The AP reviewed what has happened since the patch came on the market in 2002.
The FDA responded to a FOIA request by providing the AP with a database that contained about 16,000 different reports of adverse reactions associated with the patch.
These ranged from mild rashes to deaths, and there were many duplicate reports. Within this collection of reports, the AP found 23 different deaths associated with the patch. The primary cause of death in those reports isn't always clear — some mention suicide, others abortion. Doctors who reviewed the 23 cases found about 17 that appeared to be clot-related, including 12 from last year.
"That number of deaths certainly sounds suspicious," said Dr. Pamela Berens [assoc prof, obstetrics and gynecology, Univ of TX Medical School, Houston]. "There may be something about the way the drug is metabolized that could increase the risk for clots."
Although the estrogen levels are similar in the patch and the pill, the hormones in a pill must be processed through the intestinal tract before they enter the blood stream. Hormones in the patch, on the other hand, go directly into the bloodstream.
Dr. Sidney Wolfe [dir, Public Citizen's Health Research Group] a consumer advocacy organization founded by Ralph Nader, said that the deaths and high rate of clots are "worrisome" and should be investigated. "These days, more often than not the problems with a drug show up after they're approved," he said.
But Dr. Daniel Shames [FDA's dir, Division of Reproductive and Urological Drug Products] who approved the agency's medical review, said he has reviewed cases of women who died using the patch and saw no cause for alarm.
Abortion-Causing Birth Control Patch Manufacturer Faces Class-Action Lawsuit
NEW YORK, July 27, 2005 (LifeSiteNews.com) – Ortho Evra manufacturer, Ortho McNeil, is facing a lawsuit filed by 10 women Monday for damages related to use of its abortifacient so-called birth-control patch. The women, who all suffered from strokes or serious blood clots, described the drug as “unreasonably dangerous,” and “defectively designed,” according to a CNN report.
NEW YORK, July 27, 2005 (LifeSiteNews.com) – Ortho Evra manufacturer, Ortho McNeil, is facing a lawsuit filed by 10 women Monday for damages related to use of its abortifacient so-called birth-control patch. The women, who all suffered from strokes or serious blood clots, described the drug as “unreasonably dangerous,” and “defectively designed,” according to a CNN report.
The women, ranging in age from 18 to 47, are from across the US and all suffer from long-term debilitating effects from the patch. Nineteen year-old Amanda Bianchi of Colorado Springs, Colo., described suffering two strokes and recurring migraines after developing a 10-inch blood clot in her brain after use of the patch in 2004. “It's not fun to have to get up and not be able to go to school and live the life that you were living, you know?” she said.
“When used as labeled, Ortho Evra is a safe and effective birth control choice for many women,” a company statement claimed. Last week, LifeSiteNews.com reported that the risk of developing a fatal or non-fatal blood clot while on the patch is three times greater than with use of the abortifacient birth-control pill.
An AP report also noted that 23 deaths were attributed to use of the patch since its US Food and Drug Administration approval in 2001. An FDA spokesman assured women that “evidence indicates the product is safe and effective,” according to a statement sent to CNN.
See related LifeSiteNews.com coverage:
Birth Control Patch Claims 23 Lives and Counting
http://www.lifesite.net/ldn/2005/jul/05071506.html
Birth Control Patch Claims 23 Lives and Counting
http://www.lifesite.net/ldn/2005/jul/05071506.html