Share At least 16 people in two states have developed severe intraocular infections after being injected with contaminated syringes of Avastin. Some patients have lost their vision to the infection and one is hospitalized because the infection spread to his brain.

Avastin is not currently approved for use in the eye and must be repackaged in a pharmacy to provide appropriate dosage and delivery method.

Yesterday, the FDA issued an alert to Health Care Professionals and urged them to ensure that their sources for repackaged Avastin are reliable.

Patients in Nashville received Avastin injections at the V.A. there, which also compounded the Avastin.  Patients in Miami were treated at various locations, but all of the Avastin came from a single pharmacy.  It is likely that the contamination occurred at these two compounding facilities.

It is important to note several things:

• The risk of a serious endophthalmitis infection with these grave consequences is always present when anything is injected into the eye.
  
  
• Incidents of endophthalmitis from intravitreal injections are rare; your doctor knows the critical steps to take to ensure your safety.
  
  
• All these infections have been traced to two compounding pharmacies, where the contamination occurred.

On the negative side, Avastin is not approved by the FDA for use in the eye. It is manufactured for intravenous use for cancer. The process of repackaging the sterile drug into smaller doses in syringes must be performed under strict condition to avoid contamination.

The FDA approved drug for eye use, Lucentis, is manufactured in single dosage vials in a very controlled laboratory environment.

On the other side of the issue, the New York Times quotes Dr. Phillip Rosenfeld, the retinal specialist at the University of Miami who pioneered the use of Avastin for macular degeneration. He pointed out that the recent incidents apparently stemmed from careless procedures by pharmacies and should not discourage the use of the drug.

"It took six years for something like this to happen," he said, noting that there have been more than two million injections of Avastin into eyes in the United States alone since the practice began in 2005.

Cost issues have driven many ophthalmologists to use Avastin instead of Lucentis.  Lucentis is covered by Medicare and there is a program in place to assist patients with copayments.  It is a very expensive treatment.  Avastin is much cheaper and is covered by Medicare in most states.  A recent clinical trial found the two treatments to be comparable, but there continues to be some concern about Avastin safety, which incidents like this do little to calm.

Patient and doctor choice is critical as individuals respond uniquely to treatment.  If Eylea is approved in November, we will have yet another therapy to add to the mix.  In the meantime, we will be watching closely as this safety issue is addressed.

September 2011