Newer Contraceptive Pills Could Raise Clot Risk, FDA
MONDAY, Sept. 26 (HealthDay News) -- U.S. health officials
issued a cautionary note Monday about an increased risk of blood
clots in women taking newer forms of birth control pills, such as
Yaz or Yasmin.
Although stopping short of a definitive statement, the U.S. Food
and Drug Administration (FDA) did say it "remains concerned" about
a potentially higher risk of blood clots in women taking the
"fourth generation" pills containing drospirenone, a new type of
These new pills -- marketed as Yaz or Yasmin, among other brand
names, in North America -- are popular, although the risk of blood
clots, also known as venous thromboembolism (VTE), has been noted
VTEs are clots that typically originate in the legs and can
travel to the lungs. They are best known as so-called "economy
class syndrome" because of cases occurring during long-haul
flights, although experts warn that they can happen at any time.
Symptoms include leg pain, chest pain or sudden shortness of
Preliminary results of an FDA-funded study show a 50 percent
increased risk of VTEs in women taking drospirenone-containing
pills versus other hormonal contraceptives.
The risk to any one woman remains small: overall, the risk of a
VTE is about six women per 10,000 users for the older
contraceptives versus 10 per 10,000 using the newer versions, the
The agency also reviewed six other studies on the subject, the
results of which were conflicting. Two studies found no difference
in risk, while another two found a 1.5-fold to 2-fold increased
And two more studies, appearing earlier this year in the
BMJ, found double to triple the risk.
The FDA issued a similar safety communication at the end of May,
after the two
BMJ studies came out.
Experts advise that women who have been on Yaz, Yasmin or
similar drugs should not discontinue use without talking to their
health care provider because they may not need to come off the pill
at all. However, newcomers to the pill might consider older
"The question is, should patients who have been on it for years, should they switch? I think they should talk to their doctors," said Dr. Jennifer Wu, an obstetrician/gynecologist at Lenox Hill Hospital in New York City. "[And] I would not start patients on this pill. Blood clots are very serious. They can kill patients. With all the options we have, we should probably start [new patients] with safer contraceptive pills."
Women with other additional risk factors for blood clots
definitely should not be on drospirenone-containing pills, Wu
Risk factors for VTE include smoking, being overweight or a
family history of blood clots.
The FDA statement released Monday noted that studies to date
have only looked at pills containing drospirenone and a higher dose
of estrogen, not those containing drospirenone and a lower dose of
estrogen. So, it's possible that some drospirenone-containing
products may be safer than others.
This isn't likely to be the last word on the matter, either: FDA
advisory committees are scheduled to delve further into the matter
at a December meeting, at which time the full findings of the
agency-funded study will be released.
Find out more on this issue at the
U.S. Food and Drug Administration.
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