Bayer's Yaz May Face More Labeling Changes On Blood Clot Warnings
This article was originally published in The Pink Sheet Daily
Executive Summary
The combination oral contraceptive's warnings were updated in March, but two recently published epidemiological studies that found a higher risk of venous thromboembolic events with drospirenone compared to levonorgestrel could result in another labeling revision.
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Blood Clot Risks For Yasmin, Yaz, Ortho Evra Get Panel Review After FDA Epidemiology Study
FDA's Reproductive Health Drugs and Drug Safety and Risk Management advisory committees will discuss the benefits and risks of drospirenone-containing drugs and the Ortho Evra patch at a two-day meeting in December.