Update Mar 07, 06

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Update Mar 07, 06

March 7th: Drug Safety Information: Macugen (pegaptanib sodium injection)

Eyetech/Pfizer and FDA notified healthcare professionals of important changes in the approved product labeling for Macugen (pegaptanib sodium injection), including changes to the CONTRAINDICATIONS, PRECAUTIONS, ADVERSE EVENTS Post-Marketing, and DOSAGE and ADMINISTRATION sections. Rare reports of anaphylaxis/anaphylactoid reactions, including angioedema following the administration of Macugen along with various medications administered as part of the injection preparation, were described. Macugen is indicated for the treatment of neovascular (wet) age-related macular degeneration, and is administered once every six weeks by intravitreous injection. Healthcare professionals should evaluate the patient's medical history for hypersensitivity reactions to Macugen prior to using this product.

For complete FDA report and labeling changes of this update, please refer to following links:
http://www.fda.gov/medwatch/safety/2006/macugen_deardoc.pdf
http://www.fda.gov/medwatch/safety/2006/Macugen_PI_mar0g.pdf

If you have comments regarding this update, please email us at info@mdiconsultants.com

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