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WebMD Health News

Wednesday, June 28, 2006

Macular Degeneration: Is 'Off-Label' Treatment Off-the-Table?
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Age-Related Macular Degeneration (ARMD) affects millions of older adults, so it's natural that our WebMD Vision & Eye Disorder member community receives many visits from concerned patients and family members.

This is a hopeful time for those affected by ARMD. New medical treatments may preserve and (in some cases) improve visual function. Click here to see an earlier blog that describes what is available.

The most heated debate concerns use of Avastin, a cancer chemotherapy drug that also stops abnormal blood vessel proliferation in ARMD. Problem is the FDA has only approved Avastin as safe and effective for cancer, not ARMD.

Many ophthalmologists now offer Avastin injections as an 'off-label' treatment. It is legal and ethical so long as you and your doctor agree on what you are both trying to accomplish.

Here's recent guidance the American Academy of Ophthalmology offered to its member physicians regarding 'off-label' therapies:
  • Familiarize yourself with the published literature and the experience of colleagues.
  • Be reasonably confident that patients would benefit from the drug.
  • Discuss all options with patients, and be clear if your recommendation is an off-label use.
  • Heed the drug's history of adverse events, and advise and monitor patients accordingly.
  • Document the decision-making process and the informed-consent discussion that led to using a drug off-label.


ARMD patients can also adapt these guidelines as their own checklist before agreeing to receive 'off-label' use of any prescribed treatment.

Related Topics: New Eye Drugs Treat Macular Degeneration, Diet/Lifestyle May Affect Eye Health

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Posted by: Dr. Lloyd at 12:33 AM

3 Comments:

Blogger Dr. Mark said...

Dr. Lloyd:

My mother received an AMD wet injection of Avastin and almost immediately developed tinnitus or some other form of ear ringing on the side where she received the injection. Have you heard of such a correlation?

Dr. Mark

11:10 AM  
Anonymous Anonymous said...

uDr. Lloyd
My wife received two Avastin injection in March and May 2006. Vision imporved. This March there was a recurrence in another location, Received two injections w no imrovement. Dr. said no further treatment now. Is there a danger of further injections. what are the possible side effects. Are ther any thing else that can be done now ?? Please respond. Dr. A. Al Habbal

7:52 PM  
Anonymous Barry Wheeler said...

It is possible for these people to be treated with Lucentis.

I have not heard of any correlation between avastin and tinnitus. I would be interested in hearing what Dr. Lloyd says about this.

Barry Wheeler
http://www.amdsupport.ca

2:42 PM  

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