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birth control patch article; ***
Topic Started: Jul 17 2005, 02:38 PM (358 Views)
apple
one of the angels
Deaths raise questions about safety of birth control patch

By MARTHA MENDOZA The Associated Press


Gingerly, Kathleen Thoren’s family gathered around her in the intensive care unit, unable to speak to their beloved sister, daughter, wife, or even stroke her hands.

The slightest stimulation might create a fatal amount of pressure on the 25-year-old woman’s swollen brain, the doctors warned.

“We were horrified, but we tried to just quietly be with her,” said her sister, Erika Klein. “In the end, it didn’t help.”

The mother of three died last fall, just after Thanksgiving, 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 thought to be related to the 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.

Several lawsuits have been filed by families of women who died or suffered blood clots while using the patch, and lawyers said more are planned.

Although the Food and Drug Administration and patch maker Ortho-McNeil Pharmaceutical 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.

Several doctors reviewed the FDA reports at the request of the AP.

“I was shocked,” said Alan DeCherney, a University of California, Los Angeles, professor of obstetrics and gynecology and editor in chief of Fertility and Sterility.

Other doctors said they would have expected some deaths, and said no investigation is warranted. They pointed to more than 4 million women who have safely used the patch, and noted 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,’ ” said 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 that 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 Katherine LaGuardia, Ortho-McNeil’s director of women’s health care.

“It’s difficult to reach a definitive answer, and privacy laws prevent us from investigating as thoroughly as we wish.”

Blood clots are an accepted risk from hormonal birth control because estrogen promotes blood coagulation. But how many clots are too many?

The Associated Press found that before the patch was approved, the FDA had already noticed that nonfatal blood clots from the patch were three times that of the pill. 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 age 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 out of 10,000 users during the clinical trials, while the rate of deaths appears to be 3 out of 200,000.


--------------------------------------------------------------------------------

First glance

■ A review of federal drug safety reports indicates that there have been more fatalities from the birth control patch than expected.

■ Some doctors who reviewed the reports expressed alarm. Others said they would have expected some deaths and no investigation seemed warranted.

Doctors warn that women should not overreact to news of deaths, saying it is more risky to remove the patch and become pregnant.

:eek: death is safer than pregnancy?


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Fizzygirl
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Yikes! Makes me glad I don't have to worry about birth control anymore.
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katie
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At 18 through 25 years of age, the last thing I wanted was to be pregnant. The concentrations of estrogen and progesterone in BCPs were higher back then ... as were the risks for complications. If I were young again, I'd risk it again for sure.

Im also very thankful I attended nursing school, gaining a little knowledge of drugs, research and such ... Media reports don't ruffle my feathers.

:)

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Mark
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:hair:

Thank you apple!

I passed that on to my wife so when day arrives that she has to discuss this with our daughters, she will have the information.
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apple
one of the angels
I'm of the mind that it is best not to take drugs, that is if one can help it and does not suffer from an ailment. I would not be a bit surprized if thalomide was taken off the market faster because of the press.
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Amanda
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I wonder if one of the problems is that although convenient, patch medication may yield irregular release rates of the active ingredients.

If the patient has on a body cream creating a barrier on part of the surface, obviously that inhibits the rate of absorption. Likewise, the surface of the adhesive patch itself may be coated however rarely, with varying amounts of the active ingredient - in this case, estrogen. I can't imagine this NOT being true at least occasionally, whereas taking pills would be more apt to contain a fixed amount. This is especially so, since the patch is to be time-release.

Seems risky to me in general - speaking as someone who has taken other meds in patch form. Those patches can peel off or just become loose. To prevent pregnancy, it seems a bit dicey.
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jon-nyc
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apple
Jul 17 2005, 06:38 PM
By contrast, with the patch, the rate of nonfatal blood clots was about 12 out of 10,000 users during the clinical trials, while the rate of deaths appears to be 3 out of 200,000.


...

Doctors warn that women should not overreact to news of deaths, saying it is more risky to remove the patch and become pregnant

:eek: death is safer than pregnancy?




THe death rate of vaginal births is 6 per 100,000. The death rate for users of the patch is 1.5 per 100,000.

So yes, these women are better off on the patch than pregnant.
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dolmansaxlil
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HOLY CARP!!!
jon-nyc
Jul 18 2005, 06:34 AM
apple
Jul 17 2005, 06:38 PM
By contrast, with the patch, the rate of nonfatal blood clots was about 12 out of 10,000 users during the clinical trials, while the rate of deaths appears to be 3 out of 200,000.


...

Doctors warn that women should not overreact to news of deaths, saying it is more risky to remove the patch and become pregnant

:eek: death is safer than pregnancy?




THe death rate of vaginal births is 6 per 100,000. The death rate for users of the patch is 1.5 per 100,000.

So yes, these women are better off on the patch than pregnant.

Thanks for posting that - I was on my way to find the same info.

That said, I'm not a big fan of hormonal birth control for a variety of reasons. But I used it myself for years and years, and realize that it is the best option for most people. I'm just happy I don't have to deal with it anymore.
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jon-nyc
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Cheers
dolmansaxlil
Jul 18 2005, 10:18 AM
That said, I'm not a big fan of hormonal birth control for a variety of reasons. But I used it myself for years and years, and realize that it is the best option for most people. I'm just happy I don't have to deal with it anymore.

So, not to make light of a serious subject or anything, but for me the is reason #36,342 why I'm glad I'm a man. :devilgrin:
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apple
one of the angels
that statement does not refer to the fact that there are non hormonal ways to avoid pregnancy...

I have nothing against birth control.... I feel however, that women today are a great big bunch of guinea pigs sometimes particularly in the hormone department. Personally, I have a sister who cannot get pregnant after 12 yrs. of the pill.. who knows if that is the cause?... and a friend who needs a heart thanks to hormone replacement therapy... of course.. the studies do not prove her problems are due to her taking the drug..

I just think we should be careful before quickly embracing what appears to be an easy fix.
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Mark
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apple
Jul 18 2005, 06:22 AM
I just think we should be careful before quickly embracing what appears to be an easy fix.

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Amanda
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apple:
Quote:
 
Personally, I have a sister who cannot get pregnant after 12 yrs. of the pill.. who knows if that is the cause?.

Actually they have only found out (or admitted) recently that the assumption they've been working with for so long about fertility and the pill -- is not well founded. They have always believed that fertility was quickly and fully regained once hormonal birth control was discontinued. They recognize now (I mean, within the last sx months) that it sometimes permanently impairs fertility.

Not that it's gone...Just far from a bouncing back situation, and sometimes much more extreme.
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Jolly
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katie
Jul 17 2005, 04:39 PM
At 18 through 25 years of age, the last thing I wanted was to be pregnant. The concentrations of estrogen and progesterone in BCPs were higher back then ... as were the risks for complications. If I were young again, I'd risk it again for sure.

Im also very thankful I attended nursing school, gaining a little knowledge of drugs, research and such ... Media reports don't ruffle my feathers.

:)

:yes:
The main obstacle to a stable and just world order is the United States.- George Soros
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kenny
HOLY CARP!!!
How can they pee with a birth control patch on? :confused:
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Mark
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HOLY CARP!!!
:lol2:
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apple
one of the angels
kenny
Jul 18 2005, 10:29 AM
How can they pee with a birth control patch on? :confused:

the same way they do with a condom
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