Two More Compounding Pharmacies Recall Drugs Over Infection Fears

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Pharmacy Recalls 89 Lots of Avastin Eye Injections

On Monday, Clinical Specialties recalled 79 lots of Avastin, which is approved by the U.S. Food and Drug Administration as a cancer drug but has been used off-label to treat macular degeneration. Clinical Specialties is a small compounding pharmacy in Georgia that takes larger doses of Avastin for cancer patients and repackages them in single dose syringes for eye patients. The drug is injected directly into the inside of the eye.

The pharmacy learned that five patients who'd received these injections came down with internal eye infections, but it was not clear what caused those infections at this time, said Austin Gore, the pharmacist who handles Avastin for Clinical Specialties. He said all five patients received their injections from the same doctor.

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Gore said he has repackaged 150,000 doses of Avastin since 2005 without it causing any problems, and his practices have not changed. Still, the pharmacy has temporarily shut down sterile operations until it can resolve the situation.

"Patient safety is of utmost concern," Gore said. He said the pharmacy was working with the FDA to find the source of the infections.

Gore insisted he was not compounding the drug because he wasn't "manipulating" it.

"It's unit-dosing out an already sterile product into a sterile unit dose," he said.

Avastin's manufacturer, Genentech, also makes a similar drug called Lucentis, which has been FDA-approved to treat macular degeneration but costs about $2,000 per injection. Avastin, on the other hand, costs $50 per injection. The catch is that Avastin comes in larger, more concentrated doses for cancer patients, so it has to be redosed and diluted by a compounding pharmacist or a doctor working in a sterile environment.

"Somebody has to open that vial and dilute it down," said Dr. Penny Asbell, an ophthalmologist who directs the Cornea Service and Refractive Surgery Center at the Mount Sinai Hospital in New York, adding that that's how Avastin's "cheapness" happens.

The FDA issued a warning in 2011 after reports that five patients went blind after receiving eye injections of Avastin in Los Angeles, and 12 more Avastin patients developed eye infections in Miami. "Health care professionals should be aware that repackaging sterile drugs without proper aseptic technique can compromise product sterility, potentially putting the patient at risk for microbial infections."

Still, Asbell said she believed compounding pharmacists were essential to the medical community because they allowed patients to get tailormade drugs that might never receive FDA-approval because they're needed by so few people.

"I wouldn't knock any compounding pharmacist," she said. "Those serious about their business, serious about what they do, maintain sterile techniques and reliable methods for special uses that may never be FDA-approved."

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