Document Detail

Clinical safety of ranibizumab in age-related macular degeneration.
MedLine Citation:
PMID:  20001757     Owner:  NLM     Status:  MEDLINE    
IMPORTANCE OF THE FIELD: Clinical safety of pharmaceutical products in the elderly is vital because of their increased risk of cardiac and other adverse events. AREAS COVERED IN THIS REVIEW: Search of the Medline database, including articles and abstracts from 1984 to 2009. WHAT THE READER WILL GAIN: Knowledge of ocular and systemic risks: The rate of endophthalmitis was 0.05% per injection (MARINA) and <0.1% per injection (ANCHOR), rates confirmed in a retrospective analysis of 14,320 injections. Moderate increases in intraocular pressure were transient, and incidences of intraocular inflammation were rarely serious. Systemic arterial thromboembolic events occurred in 4.6 and 0% of ranibizumab-treated patients and in 3.8 and 0% of sham-treated patients in MARINA (2 years) and PIER (1 year), respectively. In SAILOR, there was a numerically higher rate of cerebrovascular stroke with 0.5 mg ranibizumab compared with 0.3 mg ranibizumab (1.2 vs 0.7%), which was a non-statistically significant trend in patients with a history of stroke. TAKE HOME MESSAGE: Although further studies to investigate the risk of stroke with ranibizumab therapy are required, repeated intravitreal ranibizumab was well tolerated and not associated with clinically significant safety risks during up to 2 years of treatment.
Ursula Schmidt-Erfurth
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Publication Detail:
Type:  Journal Article; Review    
Journal Detail:
Title:  Expert opinion on drug safety     Volume:  9     ISSN:  1744-764X     ISO Abbreviation:  Expert Opin Drug Saf     Publication Date:  2010 Jan 
Date Detail:
Created Date:  2009-12-21     Completed Date:  2010-03-04     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  101163027     Medline TA:  Expert Opin Drug Saf     Country:  England    
Other Details:
Languages:  eng     Pagination:  149-65     Citation Subset:  IM    
Medical University of Vienna, Department of Ophthalmology, Waehringer Guertel 18-20, A-1090 Vienna, Austria.
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MeSH Terms
Angiogenesis Inhibitors / adverse effects*,  therapeutic use
Antibodies, Monoclonal / adverse effects*,  therapeutic use
Choroidal Neovascularization / complications,  drug therapy
Clinical Trials as Topic
Drug Therapy, Combination / adverse effects
Endophthalmitis / chemically induced
Eye Diseases / chemically induced*
Hemorrhage / chemically induced
Macular Degeneration / complications,  drug therapy*
Porphyrins / administration & dosage,  adverse effects*
Thromboembolism / chemically induced
Reg. No./Substance:
0/Angiogenesis Inhibitors; 0/Antibodies, Monoclonal; 0/Porphyrins; 0/ranibizumab; 129497-78-5/verteporfin

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine

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