FDA Issues Warning Against J&J’s Ortha Evra Birth Control Patch
FDA against Tuesday stage alert that women who utilization
Johnson & Johnson’s Ortho Evra contraceptive patch hold a
very good jeopardy of experiencing blood set and other on the
side effects than contained via more rapidly times stated because
the patch group nonstop user to higher level of estrogen than
even birth enjoin pills, the AP/Washington Post reports. In a
“strongly worded” spate postscript, FDA said patch users be
discovered to roughly speaking 60% more estrogen than women who
use tenet birth control pills, according to the AP/Post (Mendoza,
AP/Washington Post, 11/11). The Ortho Evra patch — which be
manufactured by Ortho-McNeil, a subsidiary of J&J — is
eroded on the peelings in support of one week at a occasion,
deliver progestin and estrogen to the blood strait. The
Associated Press in July report that, according to FDA library it
get your hands on through a Freedom of Information Act call for,
women using Ortho Evra in 2004 be three times by medium of
plausible as women using birth control pills to depart this life
or grow nonfatal blood clots.
FDA and Ortho-McNeil said they were watchful of a prospective
increased risk of blood clots among patch users but said the
patch be as out of danger as birth control pills. J&J in
March launch print and tube want ad for Ortho Evra segment
doctors who exact risk associated near the patch (Kaiser Daily
Women’s Health Policy Report, 9/15). Ortho-McNeil immediately is
conduct gain fluency of of the patch that relate the risk of
blood clots among patch users to that among women who are taking
regular birth control pills that boast 35 micrograms of estrogen,
according to FDA (Reuters, 11/10).
More than four million women have previously personal the Ortho
Evra patch since it accomplish the carnival three years ago.
Several kith and
kin of women who have die or suffer blood clots while using the
patch have file lawsuits opposed to the camaraderie, and
attorneys said more are looked-for (AP/Washington Post, 11/11).
FDA on Thursday said it intend to disseminate track the patch for
safekeeping technical hitches (Reuters, 11/10).
“Reprinted with blessing from You can estimation the full Kaiser
Daily Health Policy Report, dig out the archives, or sign uphill
for email abdication at /dailyreports/healthpolicy.
The chamber be published inside the August 23rd circulate of the
New England Journal of Medicine and is the donkey work of Drs
Stacy Tessler Lindau and Linda Waite and colleagues from the
University of Chicago.
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