AMD Alliance, Representing AMD Patient Organizations Globally, Encourages Health Care Providers to Stop Using Avastin for Off-Label Ocular Use
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.
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:
- Australia (19 cases of severe eye inflammation were reported): Sanjeewa S. et al, Acute Intraocular Inflammation after Intravitreous Injections of Bevacizumab for Treatment of Neovascular Age-related Macular Degeneration Ophthalmology 2008;115:1911-1915
- Austria (8 cases of severe eye inflammation were reported): Georgopoulos et al, Characteristics of severe intraocular inflammation following intravitreal injection of bevacizumab (Avastin). British Journal of Ophthalmology, 2009;93(4):457-462
- Germany (5 cases of severe eye inflammation reported): Statement available at http://wissen.spiegel.de/wissen/image/show.html?did=60666870&aref=image038/2008/09/27/ROSP200804001400141.PDF&thumb=false
- Canada (105 cases of severe eye inflammation): Health Canada requested label update on Avastin to include warnings on unlicensed intravitreal use available at http://ophthalmologyrounds.ca/modules/contentManager/upload/document/alwaysOnLine/ScientificUpdate_en.pdf
- China (61 cases of eye infection reported): Reported at http://www.chinadaily.com.cn/china/2010-09/24/content_11340951.htm
- U.S. (12 cases of eye infection reported: FDA warning available at http://www.fda.gov/Drugs/DrugSafety/ucm270296.htm
(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.