FDA Warns On Eye Infections With Repacked Avastin

FDA Warns On Eye Infections With Repacked Avastin

August 31st, 2011 // 12:56 pm @

The Food and Drug Administration said repackaged injections of Roche Holding AG’s (RHHBY, ROG.VX) Avastin have caused a cluster of serious eye infections in Florida.

Avastin, a cancer drug, is used by many doctors off-label to treat an eye condition known as wet age-related macular degeneration. Roche markets a similar drug, Lucentis, that’s specifically approved for use in the eyes.

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In a posting on its website late Tuesday, the FDA said it was notified by the Florida Department of Health about streptococcus endophthalmitis infections in three clinics following intravitreal injection of repackaged Avastin.

Investigators then traced the tainted injections to a single pharmacy in Hollywood, Fla. that had repacked Avastin from larger vials into single-use syringes.

FDA said the pharmacy then distributed the Avastin to multiple eye clinics for use in treating patients. The agency said it is aware of at least twelve patients in three of the clinics who had the eye infection. The infection appears to have caused some of the patients to lose the remaining vision in the eyes that were infected. The patients already had some vision loss related to macular degeneration.

The FDA said that while the investigation into the source of the Florida eye infections isn’t complete, the common link for the infections is the pharmacy that repackaged the Avastin and the single lot of Avastin used in the repackaging.

The FDA said “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.”

Avastin and Lucentis work by inhibiting a protein involved in blood-vessel formation. Lucentis is meant to be injected into the eyes each month.

Lucentis has been controversial because of its roughly $2,000 monthly price tag, so some doctors have used Avastin to treat AMD. Avastin costs about $50 a month to administer because a much smaller dose of the normally expensive cancer drug is needed.

Roche has long argued that Lucentis is a safer option to use than Avastin because it was designed specifically for the eye. The company recorded about $1.7 billion worth of Lucentis sales in the U.S. last year. Novartis AG (NOVN.VX, NVS) sells the drug outside the U.S.

The FDA’s warning has the potential to boost Lucentis sales if doctors who currently use Avastin switch to Lucentis.

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