WAYNE, N.J., March 25, 2011 /PRNewswire/ — Bayer
HealthCare Pharmaceuticals Inc. today announced that interim
results from a large, prospective, observational cohort safety
study offer insights into the increased risk of venous
thromboembolism (VTE), or blood clots, which is a well-established
risk in women who use combination oral contraceptives (COCs), also
known as “the Pill”.
Specifically, the new data provides healthcare providers with
information regarding when the VTE risk associated with COCs is
highest. The risk of VTE is highest during the first year of
COC use and the new data suggest that this increased risk is
greatest during the first six months. This risk is greatest
when first starting the Pill and when restarting the same or a
different Pill after a four week or greater break.
The new data are from the ongoing, Long-Term Active Surveillance
Study for Oral Contraceptives (LASS) – a large,
multinational, prospective cohort, five-year follow-up safety study
to the European Active Surveillance (EURAS) study. Cardiovascular
events, including VTE, were the main clinical outcomes studied in
LASS. Together, these two studies will provide data for up
to ten years on women using various COCs.
“As a leader in women’s contraception, we believe it is
important for Bayer to take the lead in studying and communicating
the risks and benefits of COCs,” said Leo Plouffe, MD, Vice
President, US Medical Affairs, Women’s Healthcare, Bayer HealthCare
Pharmaceuticals. “The new information is helpful because
while healthcare providers have long known about the risk of VTE
associated with COCs, there was little information to indicate that
there was an increased risk in women restarting COCs after a four
week or greater period of non-use. This new information
should provide both healthcare providers and women who choose a COC
for contraception with additional information when making the
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