Birth-Control Patch May Pose Health Risk

[xynthee]

I can't believe I trusted the FDA and the drug companies when they said the risks associated with the patch were the same as those with the pill!! The truth is you're THREE TIMES more likely to have problems with blood clots if you're using the patch.

The same = three times greater??

http://news.yahoo.com/s/ap/patch_problems;_ylt=AkPr69CH_ZWHW_rlpq48upYDW7oF;_ylu=X3oDMTBiMW04NW9mBHNlYwMlJVRPUCUl

About a dozen women, most in their late teens and early 20s, died last year from blood clots believed to be related to the birth-control patch Ortho Evra. 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 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.

[dorktv]

1. I have not used the patch in years but I did have two miscarriages

recently...wonder if there is a connection.

[supernova]

2. Why would it be 3x higher?

You're getting the same does of hormones, supposesdly. :shrug:

[xynthee]

5. They don't seem to know why

from the article:

That number of deaths certainly sounds suspicious," said Dr. Pamela Berens, associate professor of obstetrics and gynecology at the University of Texas Medical School at 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.

[holboz]

3. Quit using the patch - felt something wasn't "quite right"

I only used it for 2 months after I had my first child. I always felt a dull annoying pain wherever I placed it. Then I started to hear about problems with the patch so I was glad I quit using it.

I'm horrible about remembering to take pills so I'm sticking with other methods! ;)

on edit: title

[whatelseisnew]

4. So do you have to wait 5-10 years before accepting USDA

approvals?

[xynthee]

6. Looks like it!!

The 5-10 year period after USDA/FDA approval seems to be the human guinea pig phase.

[Ripley]

7. Thanks for posting this info...I'll pass it on.

I've never heard boo about this issue in any news sources. I'm on the oral version, so not affected, but I know women on the patch.

And they sure are heavily marketing that Patch to the young women - I see ads in zines about it like it is just a fashion accessory, but hidden. :eyes:

[whatelseisnew]

8. Similar thing happened with Depo Provera recently

http://www.fda.gov/bbs/topics/ANSWERS/2004/ANS01325.html

FDA Talk Paper
T04-50
November 17, 2004

Media Inquiries: 301-827-6242
Consumer Inquiries: 888-INFO-FDA

Black Box Warning Added Concerning Long-Term Use of Depo-Provera Contraceptive Injection

The Food and Drug Administration (FDA) announced today that a "black box" warning, highlighting prolonged use may result in the loss of bone density, will be added to the labeling of Depo-Provera Contraceptive Injection, an established injectable drug approved for use in women to prevent pregnancy.

Although Depo-Provera Contraceptive Injection has been used for decades for birth control throughout the world and remains a safe and effective contraceptive, FDA and Pfizer, the drug's manufacturer, are taking this action to ensure that physicians and patients have access to this important information.

The black box warning for Depo-Provera highlights that prolonged use of the drug may result in significant loss of bone density, and that the loss is greater the longer the drug is administered. This bone density loss may not be completely reversible after discontinuation of the drug. Thus the warning states that a woman should only use Depo-Provera Contraceptive Injection as a long-term birth control method (for example, longer than two years) if other birth control methods are inadequate for her.

Black box warnings are designed to highlight special problems, particularly those that are serious, and to give health care professionals a clear understanding of a potential medical complication associated with a drug. Black box warnings provide physicians with important insights as to how to prescribe a drug that may be associated with serious side effects in a way that maximizes its benefits and minimizes its risks.

The addition of the black box warning came as a result of the drug manufacturer's and FDA's analysis of data that clarified the drug's long-term effects on bone density.

In addition to the black box warning on the labeling, the drug's manufacturer will issue a "Dear Health Care Practitioner" letter regarding the effect of long-term treatment on bone mineral density to prescribers likely to prescribe the drug, and will incorporate the new information in the patient information sheet distributed with the drug.

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