Identifying systemic safety signals following intravitreal bevacizumab: systematic review of the literature and the Canadian Adverse Drug Reaction Database

Micieli, Jonathan A; Micieli, Andrew; Smith, Andrew F.

doi:10.3129/i10-027

Cited by 31 publications

(17 citation statements)

References 45 publications

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“…A low rate of systemic adverse events is documented in adults (Bakri et al. 2007), whereas cerebrovascular accidents have been reported in 0.21% of neonates (Micieli et al. 2010).…”

Section: Discussionmentioning

confidence: 99%

Time to consider a new treatment protocol for aggressive posterior retinopathy of prematurity?

Spandau

Tomic

Ewald

et al. 2012

Acta Ophthalmologica

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ABSTRACT.Purpose: To discuss treatment modalities for aggressive posterior retinopathy of prematurity (AP-ROP). Methods: The medical charts of all infants with AP-ROP at Uppsala University Hospital, Sweden, during a 2-year period (2009 and 2010) were reviewed. Eight infants (16 eyes) with a mean gestational age of 23.8 weeks and a mean birth weight of 592 g were treated with laser and ⁄ or intravitreal injections of bevacizumab (0.4 and 0.625 mg). RetCam photography was used to document the retinal appearance before and after treatment. Results: All infants (16 eyes) had AP-ROP in zone I. Mean time at initial treatment was 34 weeks postmenstrual age. Two eyes (one infant) were only treated with laser, and six eyes (three infants) were treated with laser therapy or cryopexy and, because of lack of regression, with bevacizumab as salvage therapy. Eight eyes (four infants) were treated with a first-line bevacizumab injection and four of these eyes (two infants) with additional laser ablation for continued disease progression in zone II. Macular dragging occurred in one eye of one infant primarily treated with laser. Conclusions: Given the high complication rate of the extensive laser treatment for zone I ROP, it is worth considering anti-vascular endothelial growth factor treatment as an alternative therapy. Further knowledge concerning side effects and long-term ocular and systemic outcome is warranted before this drug becomes general clinical practice.

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“…A low rate of systemic adverse events is documented in adults (Bakri et al. 2007), whereas cerebrovascular accidents have been reported in 0.21% of neonates (Micieli et al. 2010).…”

Section: Discussionmentioning

confidence: 99%

Time to consider a new treatment protocol for aggressive posterior retinopathy of prematurity?

Spandau

Tomic

Ewald

et al. 2012

Acta Ophthalmologica

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“…In addition, the potential sideeffects of this off-label therapy when used in patients with concurrent cardiovascular conditions may affect the ophthalmologist's decision-making in choosing bevacizumab for the treatment of BRVO-associated macular edema [14]. Formal evaluation of the safety and efficacy of IVB in the treatment of BRVO-associated macular edema is therefore warranted because of the increasing use of IVB.…”

Section: Introductionmentioning

confidence: 98%

Use of bevacizumab for macular edema secondary to branch retinal vein occlusion: a systematic review

Yilmaz

Cordero‐Coma

2012

Graefes Arch Clin Exp Ophthalmol

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Clinicians should use this review as an indicator that IVB is effective in improving VA and CMT values in the long-term in patients with BRVO-associated macular edema. It is important to note, however, that statistically significant improvements in VA in the short term could be seen. This review's main aim was to serve as an evidence base for potentially using other modalities, such as IVB, which seems to be reserved for certain cases.

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“…5 Although local intravitreal bevacizumab therapy might minimize the systemic side effects, cardiovascular adverse effects such as hypertension have been observed in some studies. 6 In theory, bevacizumab will elevate blood pressure by reducing nitric oxide synthase in endothelial cells, decreasing vascular permeability. 7 Thus, bevacizumabrelated hypotension needs more attention because this mechanism is unexpected, although it has been mentioned in product information, presenting an incidence rate of 7% to 15%.…”

mentioning

confidence: 99%

Hypotension Associated With Intravitreal Bevacizumab Therapy for Retinopathy of Prematurity

Yang

Lin

et al. 2016

Pediatrics

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Bevacizumab is an antivascular endothelial growth factor (VEGF) monoclonal antibody, approved as an additional medication with other chemotherapy drugs for the treatment of metastatic cancer. 1 It has been used off-label to decrease retinal thickening in age-related macular degeneration and to diminish intraoperative complications in diabetic retinopathy patients. 2,3 In addition, randomized trials have shown improvement of the retina and reduced zone I disease progression with intravitreal bevacizumab therapy for retinopathy of prematurity (ROP) in preterm infants. 4 Systemic cardiovascular complications of intravenous bevacizumab have been reported, including hypertension, thromboembolic events, cardiac ischemia, cerebrovascular ischemia, and bleeding. 5 Although local intravitreal bevacizumab therapy might minimize the systemic side effects, cardiovascular adverse effects such as hypertension have been observed in some studies. 6 In theory, bevacizumab will elevate blood pressure by reducing nitric oxide synthase in endothelial cells, decreasing vascular permeability. 7 Thus, bevacizumabrelated hypotension needs more attention because this mechanism is unexpected, although it has been mentioned in product information, presenting an incidence rate of 7% to 15%. 8 One retrospective study in Japan also reported that 25 colorectal patients with cancer presented a temporary blood pressure drop within 90 minutes of intravenous bevacizumab. 9 Neither systemic adverse events nor hypotension effects were reported in clinical trials after treatment with bevacizumab for ROP 4,10,11 ; however, the serum level of bevacizumab has been detected after intravitreous injection in preterm infants. 12 To provide more safety information for bevacizumab in preterm infants, we report a case of twin preterm infants treated abstract Intravitreal bevacizumab therapy in preterm infants for retinopathy of prematurity (ROP) can be associated with hypotension. We report twin preterm infants who developed hypotension within 1 day after intravitreal bevacizumab therapy for ROP. Before receiving the medication, their clinical statuses were stable and similar. The dose, procedure, and premedication were the same; however, twin B presented with hypotension for 3 days. Although bevacizumab-related hypotension has been described in product information (incidence rate 7%-15%), this is the first case report of intravitreal bevacizumab for ROP inducing hypotension. Physicians should be aware of intravitreal bevacizumab therapy-related hypotension when treating ROP. We suggest conducting a postmarketing active surveillance on the systemic adverse effects of this regimen in preterm infants.

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Identifying systemic safety signals following intravitreal bevacizumab: systematic review of the literature and the Canadian Adverse Drug Reaction Database

Cited by 31 publications

References 45 publications

Time to consider a new treatment protocol for aggressive posterior retinopathy of prematurity?

Time to consider a new treatment protocol for aggressive posterior retinopathy of prematurity?

Use of bevacizumab for macular edema secondary to branch retinal vein occlusion: a systematic review

Hypotension Associated With Intravitreal Bevacizumab Therapy for Retinopathy of Prematurity

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