Macugen FDA Alerts
The FDA Alert(s) below may be specifically about Macugen or relate to a group or class of drugs which include Macugen (pegaptanib).
MedWatch Safety Alerts are distributed by the FDA and published by Drugs.com. Following is a list of possible medication recalls, market withdrawals, alerts and warnings. For the latest FDA MedWatch alerts, go here.
Recent FDA Alert(s) for pegaptanib
Macugen (pegaptanib sodium injection)
Apr 7, 2006
Audience: Ophthalmological healthcare professionals, surgical service supervisors and other healthcare professionals[Posted 04/07/2006] (OSI)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.
[March 6, 2006 - Dear Healthcare Professional Letter - (OSI)Eyetech/Pfizer]