A Retrospective Study of Adverse Reactions With the Infusion of Verteporfin for Photodynamic Therapy Using a Standardized Data Collection Form

Abstract

Abstract: : Purpose: We reviewed the side effects and adverse events associated with the infusion of verteporfin for photodynamic therapy. Methods: The clinical histories and outcomes of 212 consecutive patients receiving photodynamic therapy with verteporfin were reviewed. Side effects associated at the time of infusion were documented. Results:A total of 212 patients (79 men, 133 women) were treated for CNV with photodynamic therapy with verteporfin. The average number of treatments per patient was 2.4 with a total number of 505 treatments. Thirty–six patients (17%) experienced a non–ocular adverse reaction during or peri–infusion of verteporfin. These adverse reactions included back pain, chest pain, leg pain, pelvic pain, and/or arm pain. All reactions were observed within minutes of the infusion and were transient; occurring during the infusion and resolving shortly after the end of the infusion. The most frequent side effect noted by patients was back pain occuring with infusion and resolving at completion of treatment. Previous treatments did not appear to coincide with the likelihood of side effects. Types of side effect reactions in patients receiving multiple treatments were found to be inconsistent. Conclusions: The percentage of patients experiencing at least one non–ocular side effect associated with the infusion of verteporfin was noted in 17% of treated patients. The most frequent reaction was back pain during the infusion and was observed to be transient and mild. The incidence was greater than previous studies have documented (0.3%–2.4%). There appears to be no correlation between type of adverse reaction and age, sex, eye, and number of treatments.

Keywords: photodynamic therapy • clinical (human) or epidemiologic studies: treatment/prevention assessment/controlled • age-related macular degeneration