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.
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.”
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.