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Visudyne (Verteporfin) - Side Effects and Adverse Reactions

 
 



ADVERSE REACTIONS

Severe chest pain, vasovagal and hypersensitivity reactions have been reported. Vasovagal and hypersensitivity reactions on rare occasions can be severe. These reactions may include syncope, sweating, dizziness, rash, dyspnea, flushing and changes in blood pressure and heart rate. General symptoms can include headache, malaise, urticaria, and pruritus.

The most frequently reported adverse events to Visudyne® (verteporfin for injection) are injection site reactions (including pain, edema, inflammation, extravasation, rashes, hemorrhage and discoloration) and visual disturbances (including blurred vision, flashes of light, decreased visual acuity and visual field defects, including scotoma). These events occurred in approximately 10%-30% of patients. The following events, listed by Body System, were reported more frequently with Visudyne therapy than with placebo therapy and occurred in 1%-10% of patients:

Ocular Treatment Site: Blepharitis, cataracts, conjunctivitis/conjunctival injection, dry eyes, ocular itching, severe vision decrease with or without subretinal/retinal or vitreous hemorrhage

Body as a Whole: Asthenia, fever, flu syndrome, infusion related pain primarily presenting as back pain, photosensitivity reactions

Cardiovascular: Atrial fibrillation, hypertension, peripheral vascular disorder, varicose veins

Dermatologic: Eczema

Digestive: Constipation, gastrointestinal cancers, nausea

Hemic and Lymphatic: Anemia, white blood cell count decreased, white blood cell count increased

Hepatic: Elevated liver function tests

Metabolic/Nutritional: Albuminuria, creatinine increased

Musculoskeletal: Arthralgia, arthrosis, myasthenia

Nervous System: Hypesthesia, sleep disorder, vertigo

Respiratory: Cough, pharyngitis, pneumonia

Special Senses: Cataracts, decreased hearing, diplopia, lacrimation disorder

Urogenital: Prostatic disorder

Severe vision decrease, equivalent of ≥4 lines, within 7 days after treatment has been reported in 1%-5% of patients. Partial recovery of vision was observed in some patients. Photosensitivity reactions usually occurred in the form of skin sunburn following exposure to sunlight. The higher incidence of back pain in the Visudyne group occurred primarily during infusion.

The following adverse events have occurred either at low incidence (<1%) during clinical trials or have been reported during the use of Visudyne in clinical practice where these events were reported voluntarily from a population of unknown size and frequency of occurrence cannot be determined precisely. They have been chosen for inclusion based on factors such as seriousness, frequency of reporting, possible causal connection to Visudyne, or a combination of these factors:

Ocular Treatment Site: Retinal detachment (nonrhegmatogenous), retinal or choroidal vessel nonperfusion, retinal pigment epithelial tear

Non-ocular Events: Chest pain and other musculoskeletal pain during infusion



REPORTS OF SUSPECTED VISUDYNE SIDE EFFECTS / ADVERSE REACTIONS

Below is a sample of reports where side effects / adverse reactions may be related to Visudyne. The information is not vetted and should not be considered as verified clinical evidence.

Possible Visudyne side effects / adverse reactions in 72 year old male

Reported by a physician from Japan on 2011-10-06

Patient: 72 year old male

Reactions: Myalgia, Product Label Issue, Musculoskeletal Pain, Musculoskeletal Stiffness, Joint Dislocation

Suspect drug(s):
Visudyne



Possible Visudyne side effects / adverse reactions in 80 year old male

Reported by a physician from Japan on 2011-10-25

Patient: 80 year old male

Reactions: Endophthalmitis, Macular Degeneration, Disease Progression

Suspect drug(s):
Visudyne



Possible Visudyne side effects / adverse reactions in 22 year old female

Reported by a health professional (non-physician/pharmacist) from Italy on 2011-11-04

Patient: 22 year old female

Reactions: Eye Infection Toxoplasmal

Suspect drug(s):
Visudyne
    Dosage: 6 mg/m^2 once iv
    Indication: Eye Infection Toxoplasmal

Visudyne
    Dosage: 6 mg/m^2 once iv
    Indication: Choroidal Neovascularisation



See index of all Visudyne side effect reports >>

Drug label data at the top of this Page last updated: 2010-04-07

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