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Rapid Point-of-Care Assay of Enoxaparin Anticoagulant Efficacy in Whole Blood
Published on: October 12, 2012
Heparin pharmacovigilance in Brazil
Daniela Rezende Garcia Junqueira1, Thércia Guedes Viana, Eliane R de M Peixoto
1Universidade Federal de Minas Gerais, Brazil. danirgj@terra.com.br
Revista Da Associacao Medica Brasileira (1992)
|June 22, 2011
Summary
Injectable unfractioned heparin in Brazil originates from porcine or bovine sources. Changes in heparin
Area of Science:
- Pharmacology
- Drug Safety
- Regulatory Science
Background:
- Injectable unfractioned heparin (UFH) is a critical anticoagulant medication.
- The biological origin of UFH can influence its pharmacological profile and safety.
- Understanding the source of UFH is vital for ensuring patient safety in clinical practice.
Purpose of the Study:
- To determine the biological origin of unfractioned heparin marketed in Brazil.
- To assess the impact of commercial product profiles and monograph changes on UFH drug safety.
- To highlight potential clinical implications of varying heparin sources and activities.
Main Methods:
- Searched Anvisa database for registered pharmaceutical products.
- Consulted the Dictionary of Pharmaceutical Specialties (DEF 2008/2009).
- Conducted a survey with pharmaceutical companies marketing UFH in Brazil.
Main Results:
- Five companies market UFH in Brazil; three are porcine-derived, two are bovine-derived.
- Only one product explicitly states its bovine origin in the package insert.
- Current UFH exhibits approximately 10% less anticoagulant activity than previously produced batches, potentially impacting clinical outcomes.
Conclusions:
- Bovine and porcine heparins are not dose-interchangeable due to distinct safety profiles.
- Close patient monitoring and response tracking are essential when using UFH.
- Adverse events related to UFH must be reported to national pharmacovigilance systems.
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