More Evidence Shows Newer Forms of 'Pill' Raise Clot
Risk, FDA Says10/27/11
THURSDAY, Oct. 27 (HealthDay News) -- The U.S. Food and Drug
Administration on Thursday said it "remains concerned" that a newer
generation of birth control pills may raise the odds for serious
blood clots more than older forms of the Pill.
The announcement concerns oral contraceptives containing a newer
type of progestin hormone called drospirenone, which includes
Bayer's Yaz or Yasmin. According to the FDA, the new study found a
higher risk of venous thromboembolisms (VTEs) -- potentially
dangerous clots -- in women on the drospirenone-containing pills
vs. those on older forms of oral contraceptives.
The FDA-funded review involved the medical histories of more
than 800,000 American women, all of whom were on some type of birth
control between 2001 and 2008. The study found that women taking
the newer oral contraceptives experienced a higher rate of clots
than women on older forms of the contraceptive pill.
The review also found that women on two other forms of birth
control -- the Ortho Evra patch from Johnson & Johnson and the
NuvaRing vaginal ring from Merck -- had a higher rate of clots.
For now, the FDA is not advising that most women switch to
another form of contraception. "If your birth control pill contains
drospirenone, do not stop taking it without first talking to your
health care professional," the agency said. "Contact your health
care professional immediately if you develop any symptoms of blood
clots, including persistent leg pain, severe chest pain or sudden
shortness of breath. If you smoke and are over 35 years of age, you
should not take combination oral contraceptives because they
increase the risk that you could experience serious cardiovascular
events, including blood clots."
Thursday's announcement was not the FDA's first word on this
issue, nor is likely to be the last. The agency issued a similar
warning in September, and in a statement released Thursday said
that, "given the conflicting nature of the findings from six
published studies evaluating this risk, as well as the preliminary
data from the FDA-funded study," it plans to host a public meeting
on the issue on Dec. 8.
The announcement Thursday comes a day after the release of a
BMJ that also found newer birth control pills were tied to a
higher risk for clots.
In that study, researchers reviewed data on all Danish women,
aged 15 to 49, who were not pregnant between January 2001 and
December 2009. During that time, more than 4,200 first episodes of
Women taking birth control pills with a newer progestin hormone
had twice the risk of clots compared to those who took the older
form of contraceptive pills.
Compared to women who did not use birth control pills, the risk
of VTE was three times higher among those who used pills with
levonorgestrel and six times higher among those who took pills with
drospirenone, desogestrel or gestodene.
But the absolute risk of VTE associated with taking the newer
pills remained relatively low, about 10 per 10,000 women, according
to the University of Copenhagen researchers.
For every 2,000 women who switched from using newer pills to
pills with levonorgestrel, there would be one less case of clots a
While some doctors may choose to prescribe birth control pills
with a lower risk whenever possible, it is crucial not to
exaggerate the risk of VTE, Dr. Philip Hannaford of the University
of Aberdeen in Scotland, wrote in an accompanying editorial in the
"Oral contraceptives are remarkably safe and may confer important long-term benefits in relation to cancer and mortality," he said in a journal news release.
Dr. Glenn Jacobowitz, vice chair of the division of vascular
surgery at NYU Langone Medical Center in New York City, said: "The
information for Yaz is not new. That has recently already been
shown in studies to have an increased risk of blood clots than
other oral contraceptives. The information on NuvaRing and Ortho
Evra would be a new, but similar finding. This is certainly
worrisome, particularly for women over age 35 and for smokers."
The American College of Obstetricians and Gynecologists has more
birth control pills.
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