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 deci