Learning Center
New In Coagulation
Wednesday, June 4, 2008
Recothrom (Thrombin, Topical (Recombinant))
Recothrom is a coagulation protein produced via recombinant DNA technology from a genetically modified Chinese Hamster Ovary (CHO) cell line. The "Indications and Usage" section of the FDA-approved labeling (PI) states:
RECOTHROM is indicated as an aid to hemostasis whenever oozing blood and minor bleeding from capillaries and small venules is accessible and control of bleeding by standard surgical techniques is ineffective or impractical.
- "A Phase 3 pivotal clinical trial showed that RECOTHROM had comparable efficacy and a significantly lower incidence of antibody formation compared to the commercially available bovine thrombin product."
This statement is false or misleading because it suggests that Recothrom is safer than the bovine thrombin product due to a lower incidence of antibody formation in the patients who took the Recothrom. However, this statement excludes important contextual information necessary to understand the limitation of this finding. According to the "Immunogenicity" section of the Recothrom PI, the development of antibodies in either group did not lead to any adverse events such as excessive bleeding. In addition, according to the "Adverse Reactions" section of the PI, the incidences of pre-specified adverse events were similar between Recothrom and bovine thrombin.
Among postmenopausal women taking oral hormone replacement therapy (HRT), the risk of venous thromboembolism was 2.5 times greater than that for non-users, but transdermal delivery appeared to be safer, according to a meta-analysis.
- This analysis confirms earlier studies that found an increased risk of venous blood clots among menopausal women taking oral hormone replacement therapy (HRT)
- Recent guidelines recommend that women receive the lowest effective dose of hormone replacement therapy for the shortest time possible.
- Note that the skin patch appeared to be safe, but the findings were hampered by a lack of trials and incomplete reporting, so future randomized controlled trials are needed.
Canonico M, et al "Hormone replacement therapy and risk of venous thromboembolism in postmenopausal women: Systemic review and meta-analysis" BMJ 2008; DOI: 10.1136/bmj.39555.441944.BE
Donna Castellone
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