Certain Birth Control Pills May Carry Higher Blood Clot
TUESDAY, April 10 (HealthDay News) -- U.S. health officials
announced Tuesday that birth controls pills containing drospirenone
-- a man-made version of the hormone progesterone -- may be
associated with a higher risk of blood clots and will require new
The U.S. Food and Drug Administration said the updated labels
will inform users that the pills -- which include products such as
Bayer's Yaz or Yasmin -- may carry as much as a tripled risk for
blood clots compared to birth control pills containing other types
of progesterone (also called progestins) such as
The agency findings came from observational studies, some of
which found increased risk for blood clots while others did not,
the FDA noted in its medication safety alert.
The decision follows recommendations made in December by an
FDA-appointed panel that several drospirenone-containing
contraceptives carry revised labels warning about an increased risk
of potentially fatal blood clots.
The FDA advisers had voted 21-5 in favor of new labels for the
oral contraceptives. These newer contraceptives have been
successfully marketed on the premise that they have fewer of the
unwanted side effects of older hormone pills such as bloating, mood
swings and acne.
Dr. Tara Narula, a cardiologist at Lenox Hill Hospital in New
York City, told
HealthDay in December that the risk of clotting with the
newer pills is "a low risk but the risk exists. The idea of the FDA
looking at this and potentially increasing the warning has no
downside. If anything, it increases awareness and that can only be
a good thing."
Previously, the panel members had voted that the newer
contraceptives, which gained initial FDA approval in 2001, are a
viable method of birth control, and that the benefits of preventing
pregnancy outweigh the health risks.
The U.S. Department of Health and Human Services has more about
birth control at
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