Rare Reactions Arise With Macugen
Pfizer Pharmaceuticals, (OSI) Eyetech Inc., and the FDA are alerting blossom adversity professionals to risks associated with injections of Macugen, a medication for wet age-related macular abatement (AMD), the accomplished could could could could cause of amaurosis a allocation of the elderly. Pfizer is a WebMD sponsor.
Since in astern 2004, there acquire been abate belletrist of anaphylaxis/anaphylactoid reactions, including angioedema, after the use of Macugen alternating with different medications administered as allocation of the blast preparation.
Angioedema is affiliated to hives but occurs below the bark instead of on the surface. It is characterized by bottomless abscess about the eyes and breach and sometimes of the genitals, hands, and feet.
What Is Wet AMD?
The wet analysis of AMD accounts for about 10% of all cases of the anguish but is acquiescent for 90% of acid eyes blow associated with AMD.
Wet AMD occurs from the beforehand of abnormal, adulterated claret argosy below the retina -- the light- astute tissue in the ashamed of the eye. The claret and aqueous that escape could could could could cause blow to axial vision, which is adapted for activities like reading, driving, and acquainted faces.
Macugen
was developed to block development of these adulterated claret vessels. It does this by blocking a beforehand bureau declared VEGF (vascular endothelial beforehand factor).
If untreated, eyes can become acutely torn to the point of blindness.
The Risks
Macugen is acclimatized already every six weeks by intravitreous blast (directly into the eye). Blossom adversity professionals are accepting told to adjudge the patient's medical history for hypersensitivity reactions to Macugen above-mentioned to appliance this product.
A complete accordance to Macugen or any of the different medications administered as allocation of the blast activity activity or added factors has not been acclimatized in these cases. The patient's medical history for hypersensitivity reactions should be evaluated above-mentioned to bold the intravitreal blast procedure.
Label Revisions
The revisions to the bold are as follows, with the new admonition in italics:
- Macugen is contraindicated [cannot be used] in patients with ocular or periocular infections.
- Macugen is contraindicated [cannot be used] in patients with accustomed hypersensitivity to pegaptanib sodium or any added excipient [injection ingredient] in this product.
The bold will aswell say:
- FOR OPHTHALMIC INTRAVITREAL INJECTION ONLY.
- Rare cases of anaphylaxis/anaphylactoid reactions, including angioedema, acquire been arise in the post-marketing associate after the Macugen intravitreal administering procedure.
Also included is this calendar about the adversity of adding how abounding bodies are afflicted by allergic reactions:
"Anaphylaxis/anaphylactoid reactions, including angioedema, acquire been articular during postapproval use of Macugen. Because these reactions are arise voluntarily from a citizenry of cryptic size, it is not consistently attainable to anxiously appraisement their affluence or accredit a causal accordance to drug."
The new bold will advise patients of the able acclimation of injecting Macugen:
"The blast activity should be agitated out below controlled antibacterial conditions, which includes the use of antibacterial gloves, a antibacterial drape, and a antibacterial eyelid speculum (or equivalent). The patient's medical history for hypersensitivity reactions should be evaluated above-mentioned to bold the intravitreal [injection] procedure."
Health adversity professionals can abode ascetic adverse blow admonition associated with the use of Macugen to Pfizer Inc. at (800) 438-1985. You can aswell abode the admonition afresh to the FDA via the MedWatch adjustment at (800) FDA-1088, by fax at (800) FDA-0178, by mail (using a postage-paid form), or the Internet at www.fda.gov/medwatch.
The Pfizer Medical Biologic Admonition Department will board admonition at (800) 438-1985.