Avastin Injection Recall

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Avastin Injection Recall

7934190_sAvastin injections, used for wet ARMD,  are again linked to eye infections.  At least five patients have developed intraocular eye infections after receiving Avastin injections distributed by the same compounding pharmacy located in Augusta, Georgia.  A voluntary recall of all sterile products from Clinical Specialities, Inc., has been issued.  Most of their drugs are distributed to Georgia, Louisiana, South Carolina, Tennessee and Indiana.

Intraocular infections, called endophthalmitis, can lead to blindness.  These are infections which occur in the inside of the eye compared to external infections such as pink eye. Clinical Specialties, Inc., is the compounding pharmacy where the injections were repackaged.

Does Avastin Cause Eye Infections

Avastin itself is safe and does not cause eye infections. Avastin is used “off label” to treat wet macular degeneration.  The parent company, Genentech, does not manufacture nor distribute Avastin specifically for eye treatments.  

Genentech manufactures Avastin for chemotherapy for treatment of various cancers including colon cancer.  It does make a very similar drug, called Lucentis, for the treatment of wet ARMD.  Lucentis is FDA approved for the eye, whereas, Avastin is not FDA approved.

Genentech, a pharmaceutical company, must adhere to strict FDA regulations as to the manufacturing process required for synthesizing and distributing their products. The manufacturing process must adhere to FDA rules to ensure the drugs to not contain bacteria, molds, viruses or contaminants.

Bacteria and molds are the biggest concern when manufacturing and could cause infection.

What is a Compounding Pharmacy?

A compounding pharmacy mixes or modifies drugs based upon a specific prescription written by a doctor.  For instance, if a patient requires a flavor added, needs a pill changed to a liquid, has an allergy to a component of the drug, etc., these changes can be made at a compounding pharmacy.

A compounding pharmacy does NOT manufacture medicine, they may remix or repackage medicines. Compounding pharmacies are not governed by the FDA.

Nowadays, very few compounding pharmacies exist.  CVS, Walgreens, Rite Aid, Costco, etc. are retail pharmacies, not compounding pharmacies. Avastin is, however, standard of care in many areas of the United States for the treatment of wet ARMD.  I use Avastin for my patients.

Repackaging Avastin

Avastin is FDA approved, and sold for chemotherapy treatment for certain cancers.  Chemotherapy requires larger volumes compared to the small 0.1 cc’s doses needed for eye treatment.  (1.0 cc is about 1/30 of a fluid ounce.  I use less than a tenth of 1.0 cc for injection!).

Avastin is purchased by a compounding pharmacy in larger quantities for cancer chemotherapy…as the drugs were intended and FDA approved. The compounding pharmacy, receives the Avastin from Genentech, and then repackages the drug for use in my office (for example).

What Does This Mean?

The problem is not the Avastin.  The problem is that the compounding pharmacy is not regulated by the FDA.  There is no governing agency to impose regulations for sterility and impose penalties for substandard conditions.

For now, make sure your doctor is not using product from Clinical Sciences, Inc.  Avastin from other sources should be safe.

Randy

Retina Specialist
Ophthalmologist
Fairfax, Virginia

Comments
  • Mike Morris March 27, 2013 at 1:29 pm

    Hi Randy – thanks for this information. Are you aware of any such contaminations issues resulting from a patient receiving Lucentis? As a follow-up, if i inform my retinal specialist on the enxt visit that i will not accept Avastin but want Lucentis, should I expec ct push-back from my insurance company or physician?

  • dipak kumar banerjee March 28, 2013 at 6:49 am

    i am suffering from wet macular degeneration, and doctor has given me Lucentic injection thrre times with no result. I am diabetic and 64 years male. What is remedy? Doctor says there is no medicine except Avastin and Lucentis. He also said there is no permanent remedy. He added there is no established reason that leads to wet macular degeneration. I am very disheartened. Kly help.
    Regards,
    banerjee

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