New Labeling for Macugen After Adverse Reports
FDA advises evaluation of patient medical history for hypersensitivity after reports of anaphylaxis
MONDAY, April 10 (HealthDay News) -- Due to post-marketing reports of anaphylactic reactions in some patients, Pfizer is updating the product labeling for Macugen (pegaptanib sodium injection), which is indicated for the treatment of neovascular (wet) age-related macular degeneration, according to the U.S. Food and Drug Administration.
The new labeling notes that Macugen is now contraindicated for patients with known hypersensitivity to pegaptanib sodium or any other excipient in the product. Post-marketing surveillance has revealed rare cases of anaphylaxis/anaphylactoid reactions, including angioedema, in patients.
Pfizer is encouraging health care professionals to report adverse events associated with the use of Macugen either directly to Pfizer at 1-800-438-1985 or to the FDA's MedWatch system.
"Health care professionals should evaluate the patient's medical history for hypersensitivity reactions to Macugen prior to using this product," FDA officials advise.