Pharmacy Services
Pegaptanib Sodium Injection (Macugen): Labeling Changes Due to Reports of Anaphylaxis and Angioedema
April 7, 2006
Pfizer has changed the labeling of pegaptanib (Macugen) due to post-marketing reports of anaphylaxis and anaphylactoid reactions, including angioedema. Changes have been made in the contraindications, precautions, adverse events, post-marketing, and dosage and administration sections to include this new information. Evaluate the patient's medical history for hypersensitivity reactions to Macugen prior to using this product.
Additional information is available at the following links:
- FDA MedWatch Alert:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm150638.htm - Revised Product Labeling:
http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021756s006,s007lbl.pdf - Letter to Healthcare Professionals:
http://www.fda.gov/downloads/Safety/MedWatch/SafetyInformation/ SafetyAlertsforHumanMedicalProducts/UCM153302.pdf
Updated
April 7, 2006; University of Utah, Drug Information Service. Copyright 2009, Drug Information Service, University of Utah, Salt Lake City, UT.
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