Possible risks from use of Ortho Evra birth control patch

Ortho McNeil, a Johnson and Johnson subsidiary, the makers of the Ortho Evra birth control patch says that women using the patch will be exposed to about 60 percent more estrogen than those using the typical birth control pill because hormones from patches get into the bloodstream and are removed from the body differently than hormones from pills. While both the patch and the pill are loaded with the same amount of estrogen, hormones from the patches go directly into the bloodstream, while pills are swallowed and digested first. About one-half the estrogen is lost through the digestive process when the pill is taken. Estrogen levels from the pill are highest one or two hours after taken, and are quite low twelve hours after taken. This means womens’ bodies are not exposed to hormones twenty-four hours a day with the pill. The patch delivers hormones continuously. The company warned women that the patch may put them at greater risk for blood clots and other serious side effects than previously disclosed.

The Associated Press (AP) reported previously that users of the patch die and suffer blood clots about three times as often as birth control pill users. Citing federal death and injury reports, the AP reported that about a dozen women, most in their late teens and early twenties, died in 2004 from blood clots thought to be related to the birth-control patch, and that dozens more survived strokes and other clot-related problems.

Documents released to attorneys, who have filed lawsuits for families of women who died or suffered blood clots while using the patch, show that the company has been analyzing the Food and Drug Administration’s (FDA) death and injury reports, creating its own charts that document a higher rate of blood clots and deaths in association with the patch than with the pill.

An internal Ortho McNeil memo shows that the company refused in 2003 to fund a study comparing its Ortho Evra patch to its Ortho-Cyclen pill because of concerns that there was “too high a chance that study may not produce a positive result for Evra,” and that there was a “risk that Ortho Evra may be the same or worse than Ortho-Cyclen.”

Company spokesman Michael Beckerich said that the company is conducting its own epidemiological study “designed with input from the FDA and similar to those previously conducted with the pill.”

Ortho Women’s Health & Urology, maker of the Ortho Evra patch announced that company funded research showed that women who use the once a week birth control patch face twice the risk of developing blood clots than women who use birth control pills. The finding comes from one of two studies comparing the patch and the pill. The first study found no increased risk of clots. The second study suggested a two-fold increase in the risk of venous thromboembolic events (clots in the legs and lungs) in women using the patch. An investigation by The Associated Press last year found that patch users die and suffer blood clots at a rate three times higher than women taking the pill. Health officials warn that women who smoke should not use the patch, since smoking increases the risk of stroke and heart attack.

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Related Articles:
Mendoza, M., “Birth-control patch firm warns drug may raise blood-clot risks,” Houston Chronicle (Nov. 11, 2005).
Warning Issued for the Birth-Control Patch,” New York Times (Nov. 11, 2005).
Bridges, Andrew, “Birth-Control Patch Users Face Clot Risk,” Associated Press (February 17, 2006).

hdhadminPossible risks from use of Ortho Evra birth control patch