We found a match
Your institution may have access to this item. Find your institution then sign in to continue.
- Title
Thromboembolic Adverse Events After Use of Recombinant Human Coagulation Factor Vlla.
- Authors
O'Connell, Kethryn A.; Wood, Jennifer J.; Wise, Robert P.; Lozier, Jay N.; Braun, M. Miles
- Abstract
The article discusses a study on thromboembolic adverse events, which were reported to the U.S. Food and Drug Administration's Adverse Event Reporting System, after use of recombinant human coagulation factor Vlla (rFVlla). The FVlla is used to control bleeding in hemophilia patients and reportedly has been used off-label in patients without hemophilia. Research methods included analysis with Premier RxMarket Advisor. Data showing the extent of use, patient demographics, reasons for use, and number of thromboembolic events is provided, as well as reported deaths. The study found that morbidity or mortality occurred more when rFVlla was used for unlabeled indications.
- Subjects
UNITED States; BLOOD coagulation factors; HEMOPHILIACS; THROMBOEMBOLISM risk factors; EXPERIMENTAL therapeutics; MEDICAL care research; DRUG side effects; UNITED States. Food &; Drug Administration; PUBLIC health surveillance; BLOOD coagulation; HEMOPHILIA treatment; MEDICAL research; RESEARCH methodology; MEDICAL care; THERAPEUTICS
- Publication
JAMA: Journal of the American Medical Association, 2006, Vol 295, Issue 3, p293
- ISSN
0098-7484
- Publication type
Article
- DOI
10.1001/jama.295.3.293