Consumer Advocacy Group Calls On FDA To Pull Ortho-Evra Weekly Patches From The Market
Submitted by Carina Rose on Fri, 05/09/2008 - 04:15
The Public Citizen's Health Research Group yesterday called on the US Food and Drug Administration to direct Johnson & Johnson to pull its birth control patch from the market after studies linked increased risk of dangerous blood clots with J&J birth control patches.
In a petition filed with the FDA, the consumer advocacy group said the amount of estrogen released from the Ortho-Evra patch varies widely among individual women, and those who absorb too much were at greater risk for blood clots and other painful side effects. Dr. Sidney Wolfe of Public Citizen wrote, "Ortho-Evra is a poor choice for women.”
Wolf wrote, "The considerable safety concern of high-dose, variable estrogen exposure tips the balance of risks and benefits against the availability of Ortho-Evra as a contraceptive." "If Ortho-Evra had been designed as a pill, it is unlikely to have been approved because of its increased estrogen content," Wolfe said.
Ortho-Evra weekly patches are in use since 2005. Several studies have indicated that the patch users have twice the risk of clots in the legs and lungs as do women who swallow the pill, because patients absorb up to 60 percent more estrogen via the patch.
