Desogestrel thromboembolism risk will be subject of FDA label review when U.K. studies are published.
Executive Summary
DESOGESTREL LABELING UPDATE TO ADDRESS BLOOD CLOT RISK is likely, FDA indicates in a Nov. 14 "Talk Paper" responding to three unpublished studies purported to show an increased risk of non-fatal venous thromboembolism with oral contraceptives containing desogestrel or gestodene. FDA intends to evaluate data on risk of arterial disease which may counterbalance the information on venous clots when labeling is reviewed. The blood clot information may contribute to a review of all OC labeling and relative risks between different generation products.
You may also be interested in...
Part D Discount Liability Coming Into Focus: CMS Releases Drug Cost Data
Newly released Medicare Part D data sheds light on the sales hit that branded pharmaceutical manufacturers will face when the coverage gap discount program gets under way in 2011
FDA Skin Infections Guidance Spurs Debate On Endpoint Relevance
FDA appears headed for a showdown with clinicians and the pharmaceutical industry over the proposed new clinical trial endpoints for acute bacterial skin and skin structure infections, the guidance's approach for justifying a non-inferiority margin and proposed changes in the types of patients that should be enrolled in trials
Shire Hopes To Sow Future Deals With $50M Venture Fund
Specialty drug maker Shire has quietly begun scouting deals with a brand-new $50 million venture fund, the latest of several in-house investment arms to launch with their parent company's pipelines, not profits, as the measure of their worth