Steps to reduce surgical risk. In: I guidelines for perioperative evaluation

GUIDELINE TITLE
Steps to reduce surgical risk. In: I guidelines for perioperative evaluation.

BIBLIOGRAPHIC SOURCE(S)
Committee on Perioperative Evaluation (CAPO), Brazilian Society of Cardiology. Steps to reduce surgical risk. In: I guidelines for perioperative evaluation. Arq Bras Cardiol 2007;89(6):e197-208.

GUIDELINE STATUS
This is the current release of the guideline.

** REGULATORY ALERT **
FDA WARNING/REGULATORY ALERT
Note from the National Guideline Clearinghouse: This guideline references a drug(s) for which important revised regulatory information has been released.

December 3, 2008, Innohep (tinzaparin): The U.S. Food and Drug Administration (FDA) has requested that the labeling for Innohep be revised to better describe overall study results which suggest that, when compared to unfractionated heparin, Innohep increases the risk of death for elderly patients (i.e., 70 years of age and older) with renal insufficiency. Healthcare professionals should consider the use of alternative treatments to Innohep when treating elderly patients over 70 years of age with renal insufficiency and deep vein thrombosis (DVT), pulmonary embolism (PE), or both.

February 28, 2008, Heparin Sodium Injection: The U.S. Food and Drug Administration (FDA) informed the public that Baxter Healthcare Corporation has voluntarily recalled all of their multi-dose and single-use vials of heparin sodium for injection and their heparin lock flush solutions. Alternate heparin manufacturers are expected to be able to increase heparin products sufficiently to supply the U.S. market. There have been reports of serious adverse events including allergic or hypersensitivity-type reactions, with symptoms of oral swelling, nausea, vomiting, sweating, shortness of breath, and cases of severe hypotension.

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