Contraception - Chemical Methods / Hormonal Contraception / Emergency / Morning After Pill

FDA Reveals 17 Deaths in 2 Years from "Contraceptive Sex Patch" (updated 11/04)

The “contraceptive sex patch” has been found responsible for 17 deaths in women age 17 to 30 since its release in 2002, according to a recent exposé by the New York Post.

The Post used Freedom of Information laws to obtain records from the U.S. Food and Drug Administration, which also revealed 21 other “life-threatening” conditions such as blood clots, strokes, and heart attacks.

 

The contraceptive, marketed by ads with super models and Olympic athletes, is touted as a sexy alternative to the Pill. The Ortho Evra patch’s manufacturer, Ortho-McNeil, claims the patch is easier to remember than the pill because it requires only a once-weekly replacement, rather than the Pill’s daily dose.

Doctors who reviewed the report were staggered by the numbers. “This is a cause for concern,” NYU Medical Center gynecologist and professor Dr. John Quagliarello said. He said it was the first time he’d heard there was such a high death rate from the patch.

The Ortho Evra patch delivers a dose of contraceptive hormones into a woman’s blood stream via the skin. These hormones can trigger fatal heart attacks, strokes, and blood clots.

Ortho-McNeil claims the death rate from its patch is “consistent with the health risks” of taking the Pill. According to them, the Pill kills 0.3 to 1.9 women of every 100,000 15 to 29 year old users. Smoking significantly increases the risk of death.

A spokeswoman for the UK’s Family Planning Association told the BBC news that “Women shouldn’t suddenly stop using the patch as they could then be at risk of unplanned pregnancy.” [New York Post; 21Sept04, LifeSiteNews.com]

Earlier and Related: An 18 year-old fashion student died in 4/04 as a result of her use of a hormonal birth-control patch device. Zakiya Kennedy approached a policeman in a New York Upper West side subway station. She complained of a severe pain in her head and leg, then she collapsed. She died an hour later in hospital.

New York medical examiners have determined that the cause was blood clots which can form when a patient is using the patch. The New York Post is calling the case, “bizarre” but both the FDA and the patch’s manufacturer have warned that the contraceptive, like the pill, carries the risk of forming potentially deadly clots.

The website of Ortho-McNeil Pharmaceutical, a manufacturer of a hormonal patch, Ortho Evra, warns of possible “serious side effects” but does not mention any danger of death.

“Some women should not use the contraceptive patch, including women who have blood clots, certain cancers, a history of heart attack or stroke.”

Kennedy switched to the patch about three weeks before and had not complained of any difficulties; she died when a clot entered her lung. [6Apr04, LifeSiteNews.com]

UPDATE:

Contraceptive linked to deaths

It’s the latest in birth control for today’s woman, a little square patch worn on the skin, which delivers the same hormonal contraceptive found in the pill but in an easier-to-remember method. “Birth control that’s on your body and off your mind,” a cheery voice says, while super-model Naomi Campbell and members of the Norwegian Olympic volleyball team appear, with their patches safely hidden beneath the trendiest fashions.
Too bad they aren’t telling the rest of the story.

Records of the U.S. Food and Drug Administration (FDA) show that 17 users of the Ortho Evra patch, aged 17 to 30, have suffered fatal heart attacks, blood clots and strokes since August 2002. Another 21 cases of serious complications have also been reported to the FDA during the same time period, the records disclose.

Susan Edelman of the New York Post used the Freedom of Information Act to retrieve the FDA records shortly after18-year-old, aspiring model Zakiya Kennedy collapsed in a mid-town New York subway station in April this year. A coroner determined the cause of Kennedy’s death to be a blood clot had that moved into her lungs. The clot was ruled to be a side-effect of the contraceptive patch she was wearing.

In addition to the reported deaths, other serious complications have also been reported, Edelman said.
In Texas, for example, a 37-year-old mother of two recently filed a lawsuit against Ortho-McNeil, the manufacturer of the patch, after she suffered a massive stroke that left her paralyzed. She had been using the patch only 12 days.

The lawsuit alleges that the patch is defective and “more dangerous than the manufacturer admits,” Edelman wrote. “The suit … claims that U.S. Food and Drug Administration records show that at least 46 women wearing the birth-control device suffered clot-related injuries, or death, in a one-year period.”

Representatives from the manufacturer claim the mortality rates for the patch are consistent with that of the pill — 0.3 to 1.9 people in every 100,000 users between the ages of 15 and 29. However, they don’t believe the number of deaths is as high as 17.
“We believe that there may have been duplicates in the FDA reports,” said Doug Arbesfeld, a representative for Ortho Evra. “The way adverse-event reporting works is that reports go in to the FDA as raw data, which has to be analyzed. Several people could report on the same incident, such as a doctor, a relative, a nurse.”

The FDA and Ortho-McNeil are investigating the claims.
Lester A. Ruppersberger, D.O., a gynecologist at St. Mary’s Medical Center, in Langhorne, who stopped prescribing birth control pills five years ago, said he was not surprised by the numbers.
“There are 15 million women a year who are taking birth control pills. If you have even one-tenth of 1 percent, you’re talking about 15,000 women a year who die from something either directly or indirectly associated with birth control pills.”

Information about the dangers of popular birth control products may be obscured through marketing that relies on statistics and numbers only medical professionals can truly understand.

“It’s all about spin,” Rupersberger said. “It’s all about how you take numbers and how you can present them in a good light or a bad light.
“The majority of the blame is with the doctors,” he said. “The doctors are not telling the patients what the potential for complications [in hormonal contraception use] are.”

Rupersberger stopped prescribing the pill five years ago, and recommends natural family planning, vitamins, diet and exercise for all of the other maladies for which the pill is often prescribed.

“The pill came out in 1960, and the patch came out in 2002. Why, after 42 years, did a manufacturer have to come out with a different way of delivering the same hormones that are readily available in the pill?”

After more than 20 years in medicine, Ruppersberger said he has learned, “It’s not about the product, or the activity its promoting, or the sexually-transmitted diseases it’s helping to spread, or the fact that there are still three million unintended pregnancies a year in this country.

“It’s about money. It’s about marketing,” Ruppersberger said. “I hear the Ortho salesman in here every week. He doesn’t talk about the pill at all anymore. All he wants to talk about is the patch, because that’s what he gets his commission on — how many patches he sells.”

“[B]irth control pills did not do what everybody expected them to do,” Rupersberger said. “…they increased the rate of unwanted pregnancies, abortion rates, sexually-transmitted disease rates, abuse rates, and pornography rates. But wasn’t the pill supposed to free women?”
Apparently, it hasn’t turned out that way.

[Susan Brinkmann at [email protected] or (215) 965-4615; 18Nov04
, http://www.cst-phl.com/041118/third.html]