23 Aug Avastin is Safe | Study Shows No Link to Infection
As reported this week in Jama Ophthalmology , the chance of contracting endophthalmitis from Avastin is no different than with the case of Lucentis.
Both are equally safe.
Several outbreaks of endophthalmitis (infection inside the eye) have occurred over the past few years questioning the safety of Avastin vs. the practices of compounding pharmacies.
What are Compounding Pharmacies?
A compounding pharmacy is NOT Walgreen’s, CVS or Rite Aid.
Compounding pharmacies can make, or “compound.” individualized specialty medications. In the case of Avastin, a compounding pharmacy will purchase large amounts of Avastin and divide them into smaller doses for use by retina specialists.
Both a compounding pharmacy and a pharmaceutical company are responsible for packaging and distributing drugs using approved sterile techniques.
Avastin is Repackaged
Avastin is only supplied in massive doses from the manufacturer. As Avastin is an FDA approved anti-VEGF treatment for certain types of cancer, it is distributed only for chemotherapy treatments. Genentech, the manufacturer, does not sell the smaller doses used for intravitreal injections (IVT).
Compounding pharmacies purchase the Avastin and re-package the drug in smaller doses for sale to the ophthalmologists.
Lucentis is Directly Shipped
In contrast, Lucentis is sold directly from Genentech to the practicing retina specialist. As Lucentis is FDA approved for eye treatments, the Lucentis is manufactured, packaged and shipped directly to the ophthalmologist.
In 2011, an outbreak of endophthalmitis caused concern over the practices of compounding pharmacies. Similar suspicions developed in 2012 over an outbreak of fungal meningitis – caused by contaminated steroid injections, but processed at a compounding pharmacy.
In 2013, the FDA released the Compounding Quality Act offering guidelines to reduce the chance of endophthalmitis.
Study Shows Avastin is Safe
The retrospective study just published in Jama Ophthalmology compared the rates of endophthalmitis between Avastin and Lucentis from 2005 to 2012, in essence, studying the two drugs BEFORE the Compounding Quality Act was created.
The authors found that there was no statistical differences in the rates of infection! In other words, Avastin itself, does not cause infection.
What Does this Mean?
Historically, the threat of blinding infection (endophthalmitis) is the biggest concern with administering intravitreal injections (IVT). It doesn’t matter if we are injecting Avastin, Lucentis, Ozurdex, etc.
In 2011, 12 cases of endophthalmitis were reported to have occurred in Florida. Though all the injections emanated from the same compounding pharmacy, it questioned whether it was the Avastin versus the pharmacy itself.
Similar concerns were noted in cases of endophthalmitis from a compounding pharmacy in Tennessee. Finally, an outbreak of meningitis, causing many fatalities, was linked to contamination from a single compounding pharmacy.
This study should alleviate concerns over use of Avastin causing blindness from endophthalmitis. Concerns over the cause of endophthalmitis are limited to the practices of the compounding pharmacies and not to the actual drugs.
Patients should find relief as Avastin continues to provide excellent treatment results from diseases such as macular degeneration and diabetic retinopathy.