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Another nationwide recall of compounded medication

March 21, 2013|By Melissa Healy
  • An Atlanta Ga. compounding agency that repackaged Avastin into syringes for use by patients with vision problems has recalled the products after FDA found the resulting product may have caused eye infections.
An Atlanta Ga. compounding agency that repackaged Avastin into syringes… (Genentech, Inc. )

A compounding company in Augusta, Ga., has recalled syringes of the cancer drug Avastin it supplied over five months to physicians treating vision problems after the Food and Drug Administration received word that five patients who received the compounded medication came down with eye infections that could leave them blind.

The FDA announced the recall Thursday after regulators conducted a preliminary inspection of Clinical Specialties Compounding Pharmacy and found "practices at the site that raise concerns about a lack of sterility assurance."

The Centers for Disease Control and Prevention sent the FDA reports it had gathered of five patients sickened with endophthalmitis, an infection within the eyeball, after having received an injection in the eye of Avastin repackaged at CSCP.

A company news release said its products were distributed nationwide between Oct. 19 and March 19.

The recall involves a cancer drug that is used off-label in the treatment of severe (or "wet") macular degeneration, a disorder that gradually causes blindness, starting with a loss of central vision. Though the FDA has not approved the marketing of Avastin for macular degeneration, many physicians use it as an alternative to more expensive therapies approved by the FDA, including ranibizumab (marketed as Lucentis) and aflibercept (marketed as Eylea).

The FDA's actions to stem the eye infections comes five months after a deadly outbreak of fungal meningitis prompted the agency to shut down the New England Compounding Center in Framingham, Mass., which delivered tainted epidural steroid injections to hospitals and medical practices across 23 states. The resulting fungal infections had cost 48 patients' lives as of last month and hospitalized hundreds more.

The absence of strong FDA enforcement powers over compounding pharmacies, and the discovery of filthy conditions at the New England Compounding Center, has spurred more aggressive FDA efforts to monitor conditions at compounding pharmacies, which repackage existing prescription drugs into made-to-order medications.

The latest news comes just four days after compounding company Med Prep Consulting Inc. recalled all its products after a Connecticut hospital found mold in bags of medicine compounded at the company's Tinton Falls, N.J., facility. Those products were shipped to hospitals in New Jersey, Connecticut, Delaware and Pennsylvania.

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