Avastin Does Not Cause Infection

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Avastin Does Not Cause Infection

The FDA issued an alert that 12 cases of intraocular infection were linked to Avastin. The infections; however, were linked to a single pharmacy and, perhaps, dirty syringes.

One of the most feared complications of eye injections is blindness.  This infection is called endophthalmitis.  Last week the FDA issued an alert the 12 cases of endophthalmitis were caused by the injections.

The cause of the infections is NOT Avastin.  There is nothing wrong with the drug itself.

Avastin Must Be RePackaged

Upon further investigation, a common denominator was a single pharmacy and, possibly, a single lot of tainted syringes.

Avastin is not FDA approved for injection into the eye, but it is standard of care.  Also, Genentech manufactures Avastin and its close cousin, Lucentis.  Lucentis is FDA approved for the treatment of wet macular degeneration.

Thus, in order for physicians like me, to get Avastin, a larger dose of Avastin is ordered.  Once received the “repackaging” of the ARMD drug involves breaking up the larger dose (usually used for chemotherapy) into many more smaller doses for the eye.  The doses are commonly broken up and placed in small syringes ready for injection.

“Repackaging” sounds kind of haphazard, but it’s not.  A licensed pharmacist will distribute the Avastin in smaller allotments under strict sterile conditions.  There are specific protocols for such “repackaging.”

Compounding Pharmacies Routinely Divide Drugs

Apparently, in one particular pharmacy, either the protocol was breached and/or the sterile laboratory conditions were not maintained and they shipped out a few contaminated syringes.  Unfortunately, this caused 12 individuals loss of vision or blindness.

Fortunately, there was a plausible explanation and widespread panic was avoided.

Avastin, itself, is safe.  The mechanisms used to deliver the drug to your doctor’s office are proven safe, too.  Realize that over 2 million injections have been given.

What Does this Mean? Normally, informed consent is obtained prior to the delivery of an injection.  We inform the patient that there is a risk of infection that could lead to blindness.  That risk is estimated to be about 1:1000 to 1:2000 (approximates the risk of cataract surgery).

The source of the infection is thought to be the bacteria that reside on your eyelashes and the surface of the eye, not the actual substance injected nor the container in which it was shipped.

In the end, this was a very rare and unfortunate event for the 12 patients, their families and their doctors.  The culprit; however, was not Avastin.

 

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Comments
  • Mike September 8, 2011 at 2:55 pm

    Hi Randy,

    thanks for the information you provide. Last week I received an Avasitn injection in my right eye (13th injection in that eye, 20th total) and when the doctor did it he said there was a little air with that injection. What does that mean? I know in the days after I had a small “bubble” in the area of the injection which subsided in a day but left behind some blood.

  • Steve and Elizabeth September 10, 2011 at 11:36 am

    Once again you’ve given a good, understandable update on a scarry news story. Thanks.

  • Katie September 11, 2011 at 7:24 pm

    My Uncle received avastin injection July 26, on July 28 he was blind. How do you find out if he was part of the contaminated Avastin? He has since had to have vitrectomy to remove infection

    • Randall V. Wong, M.D. September 12, 2011 at 4:44 am

      Dear Katie,

      I am sorry to hear of this. Was he in FL? I would first ask his doctor.

      I am guessing you could also make inquiries to the FDA and the CDC.

      r

  • SHERRY September 14, 2011 at 10:49 am

    Hey Randy
    Do we know WHICH compounding pharmacy may have had the breach / problem?
    Thanks,
    Sherry

  • Kendra Gidley February 14, 2012 at 9:19 pm

    I just got a shot of avastin back in September of 2011. I am just trying to read up on it. I have Ocular Histoplasmosis and I am terrified. I am only 25. I am the youngest patient my eye Dr has seen with it and he was very surprised to see the hemorraging cleared from my eye. I do not see wavey lines anymore. I do know I need glasses, but I think do I need glasses or are my eyes acting up again? It’s the worste knowing one day I could go blind because of this disease, or I geyess because of an Avastin shot. I do however see it was in FL. Yet still

    Very concerned and worried..

    • Randall V. Wong, M.D. February 15, 2012 at 8:49 am

      Dear Kendra,

      If you think your vision is getting worse, I would suggest a visit to your eye doctor. The neovascularization from the Histo can grow back….even if there is no distortion.

      With diligent care and visits, it is quite possible you are able to save your own vision!

      Randy

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