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Rare reports of anaphylaxis reactions prompt Macugen labeling change
The manufacturers of pegaptanib sodium for the treatment of wet age-related macular degeneration have changed its prescribing information following reports of anaphylaxis/anaphylactoid reactions to the drug, the Food and Drug Administration announced.
Macugen (pegaptanib sodium, Pfizer and OSI Pharmaceutical) is administered once every 6 weeks by intravitreous injection.
In an open letter to health care professionals, the companies said that “since market introduction in the United States, there have been rare reports of anaphylaxis/anaphylactoid reactions, including angioedema” associated with the procedure.
There has been no direct relationship established between these reactions and Macugen, or the various medications administered as part of the injection process, the companies said. Company officials recommend that physicians ascertain a patient’s tendency toward hypersensitivity reactions before administering Macugen.