FDA Issues Warning on GA Compounding Pharmacy Recall

FDA Issues Warning on GA Compounding Pharmacy Recall

March 25th, 2013 // 4:10 pm @

May 7 – FDA Recall Chief Update – How to Design a Bulletproof Product Recall Strategy

FDA is warning doctors that a Georgia-based compounding pharmacy is recalling dozens of lots of the Roche drug Avastin after receiving reports of eye infections among patients.

The FDA said last week that Clinical Specialties of Martinez, Ga., has received five reports of eye infections from physicians who used the drug to treat macular degeneration, a common vision disorder in seniors.

The compounding pharmacy is recalling 40 lots of Avastin distributed to doctors’ offices in Georgia, Louisiana, South Carolina and Indiana since Dec. 18, the FDA said in an online posting.

May 7 – FDA Recall Chief Update – How to Design a Bulletproof Product Recall Strategy

Avastin is approved as a cancer drug, but it is structurally similar to Lucentis, another Roche drug approved for macular degeneration. For years, compounding pharmacies have repackaged Avastin into small vials for use by eye doctors who prescribe it off-label, or without FDA approval. Repackaged injections of Avastin cost about $50, compared with $1,950 for Lucentis.

A call placed to Clinical Specialties’ lead pharmacist, Austin Gore, was not immediately returned.

Swiss drugmaker Roche has tried to discourage doctors from using Avastin for such unapproved uses. The company points out that Lucentis was specifically tested and formulated for use in the eye, and its price reflects the cost of that research and development.

However, groups like the American Academy of Ophthalmologists say there is no detectable difference in outcomes for patients. More than half the injections given for macular generation in the U.S. are Avastin, according to the group.

Age-related macular degeneration is the most common cause of blindness among older Americans, affecting about 2 million people in the U.S. over age 50. The condition causes new blood vessels to grow in the eye and leak blood and fluid, damaging the retina and distorting vision.

In recent weeks the FDA has stepped up inspections of compounding pharmacies across a dozen states after a fungal meningitis outbreak last year tied to compounded drugs.

A tainted steroid distributed by a Massachusetts-based compounding pharmacy killed 50 people and has sickened more than 720 nationwide. Many of the cases involved a rare form of meningitis tied to fungus found in the New England Compounding Center’s facilities. The company has been shut down since the outbreak was discovered in September.

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