Navigation Links
AMD Alliance, Representing AMD Patient Organizations Globally, Encourages Health Care Providers to Stop Using Avastin for Off-Label Ocular Use
Date:10/19/2011

NEW YORK, Oct. 19, 2011 /PRNewswire/ -- It is well known that ophthalmologists around the world often prescribe Avastin (bevacizumab) off-label for wet age-related macular degeneration (AMD) over the approved treatment Lucentis (ranibizumabintravitreal) due to cost and the belief that the two have similar efficacy.

AMD Alliance International (AMDAI) is calling for ophthalmologists to stop this practice in light of a concerning surge in eye infections over the past month in patients being treated with repackaged Avastin.(i) The US Food and Drug Administration (FDA) has issued a formal warning to health care professionals about Avastin's risk for infection(ii). The US Department of Veterans Affairs has also stopped using Avastin in wet AMD patients.(iii) The Alliance urges other healthcare providers to follow suit.    

"AMDAI always advocates that evidence-based medicine and patient safety should set as the preferred treatment protocol for wet AMD, not cost," said Narinder Sharma BSc. Hons., MBA, PGDL, CEO of AMDAI. "In this case, the approved treatment based on safety and efficacy data is Lucentis. Unfortunately, we have effectively traded patient safety for money. That is just not acceptable."

Furthermore, since Avastin is not approved for ocular use, there is no pharma covigilance program for Avastin in ocular use, therefore side effects and safety issues are not monitored or reported.

AMDAI is also strongly recommending the following actions:

  • Patients and caregivers should practice increased vigilance and informed consent:
    • Patients should ask their health care providers about and fully acknowledge all possible risks associated with Avastin.
    • Patients should work with their health care providers to gain access to approved treatments whenever possible.
  • Physicians should stop prescribing Avastin as the first-line treatment for wet AMD, as advised by the US Department of Veterans Affairs(iii), especially if Lucentis is available to their patients through insurance coverage.  
  • Manufacturers of licensed therapies, Medicare and other health insurers should work together to increase access to safe and approved treatments.  

"AMD is a debilitating disease and without treatment can lead to blindness," said Alan Cruess, MD, Chairman, Department of Ophthalmology and Visual Sciences, Dalhousie University and Chairman of AMDAI's Scientific Advisory Panel. "Patients diagnosed with AMD are going through a lot of confusion and uncertainty. They need access to safe and effective medicines and shouldn't have to worry about sacrificing safety when it comes to treatment."

AMDAI strongly encourages doctors, patients with wet AMD and their caregivers to fully understand the issue before making a treatment decision. A more detailed summary of known risks and cost issues associated with Avastin and Lucentis is available at amdalliance.org.

About AMDAI

AMD Alliance International strives to bring knowledge, help and hope to individuals and families around the world affected by AMD. Our mission is accomplished through:

  • Generating awareness and understanding of age-related macular degeneration;
  • Promoting the importance of education, early detection, knowledge of treatment and rehabilitation options; and
  • Preserving vision and improving the quality of life of individuals affected by age-related macular degeneration.  

(i) Consists of aggregate data from the following countries:


(ii) FDA Alerts Health Care Professionals of Infection Risk from Repackaged AvastinIntravitreal Injections. Available at http://www.fda.gov/Drugs/DrugSafety/ucm270296.htm

(iii) US Department of Veterans Affairs public statement.


'/>"/>
SOURCE AMDAI
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. OXIS International Assumes Control and Exploitation Rights to Key L-Ergothioneine Patent Filing Representing a Major Market Opportunity
2. Investment in Oncology Drug Development Remains Strong as 133 Companies Initiate Late-Stage Clinical Trials Representing a 21% Increase
3. Dendreon Announces Publication of Phase 1 Study Highlighting Immunologic and Clinical Activity of Lapuleucel-T (Neuvenge(R)) in Advanced Breast Cancer Patients
4. Cephalon Announces Positive Results from a Pivotal Study of FENTORA in Opioid-tolerant Patients with Non-cancer Breakthrough Pain
5. Millennium Initiates Clinical Trial to EVOLVE the Treatment of Patients with Newly Diagnosed Multiple Myeloma
6. Allos Therapeutics Initiates Study of PDX in Patients with Cutaneous T-Cell Lymphoma
7. Vion Pharmaceuticals Completes Accrual of 85 Patients to its Pivotal Phase II Trial of Cloretazine(R) (VNP40101M) in Elderly AML
8. Sixty-One Percent of Newly Diagnosed Parkinsons Disease Patients Do Not Receive Any Drug Treatment in the First Year of Diagnosis
9. TaiGen Biotechnology Successfully Completes Patient Recruitment for Phase II Trial of Nemonoxacin for Treatment of Adult Community Acquired Pneumonia (CAP)
10. Callisto Pharmaceuticals Opens Additional Sites for Phase II Clinical Trial of Atiprimod in Advanced Carcinoid Cancer Patients
11. TorreyPines Therapeutics Completes Patient Enrollment in Phase IIb Clinical Trial of Tezampanel for the Treatment of Acute Migraine Headache
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:2/23/2017)... NEW YORK , Feb. 23, 2017 ... presentations and one poster presentation at PittCon ... Chicago IL.  Pittcon is the world,s largest ... science and serves a wide array of ... sciences, pharmaceutical discovery and QA, food safety, ...
(Date:2/23/2017)... This report analyzes analyzes the worldwide markets for Wound Debridement Products ... the US, Canada , Japan ... , Latin America , and Rest ... period 2015 through 2022. Also, a six-year historic analysis is ... from primary and secondary research. Company profiles are primarily based ...
(Date:2/23/2017)... NEW YORK , Feb. 22, 2017 Mixed ... The mixed tocopherols market is projected to reach ... from 2016. The market is driven by factors such as ... & beverages and in feed, and regulations for sourcing, processing, ... for mixed tocopherols from emerging markets such as the ...
Breaking Medicine Technology:
(Date:2/22/2017)... ... February 22, 2017 , ... ... medicine in recent years. The technology is so cutting edge, in fact, the ... protocol for stem cell procedures. However, successful patient outcomes in certain clinical stem ...
(Date:2/22/2017)... ... 22, 2017 , ... The National Academy of Certified Care ... April 2017 testing period. NACCM, a nonprofit organization, has provided the premier certification ... is periodically re-calibrated to ensure that newly certified professionals are prepared to work ...
(Date:2/22/2017)... ... February 22, 2017 , ... ... leverages advanced data analytics to accurately understand each Medicare Advantage member’s risk, ... a given population. This new solution helps transform the HCC Risk Adjustment ...
(Date:2/22/2017)... ... ... Doctors on Liens is continuing its steady expansion of medical specialties throughout ... North Valley Eye Medical Group in Mission Hills . Eye injuries and vision ... cases. These injuries have a major impact on the quality of life of ...
(Date:2/22/2017)... , ... February 22, 2017 , ... Using the power ... utilizing a simple online checklist. Over a period of just 24 months, thousands of ... of an online checklist called T.A.D. , “The internet is not getting quieter. In ...
Breaking Medicine News(10 mins):