The U.S. Food and Drug Administration said Wednesday that a compounding pharmacy has voluntarily recalled syringes of Swiss pharmaceutical giant Roche Holding AG's (RHHBY) drug Avastin due to the risk of eye infections. The agency warned doctors having the recalled product to stop using it immediately.
The FDA said that the risk was identified after the compounding pharmacy Clinical Specialties, of Georgia, received reports of five intra-ocular infections from physicians who used the drug to treat an eye condition called macular degeneration. The product was being used solely as an off label use by an ophthalmologist for macular degeneration and is packaged in sterile syringes.
Avastin is a cancer drug, but smaller doses of the drug are being used to treat macular degeneration. However, Roche has been warning physicians to stop using Avastin for unapproved uses such as macular degeneration as the company markets another similar drug Lucentis that has been approved for use in the treatment of eye disorders.
Lucentis was developed by another Swiss drug maker Novartis AG (NVS) and Genentech, a member of the Roche Group. Genentech has the commercial rights to Lucentis in the U.S., while Novartis has exclusive rights in the rest of the world.
Clinical Specialties is recalling several lots of Avastin that were distributed to doctors' offices in Georgia, Louisiana, South Carolina, and Indiana from December 18, 2012 to present. The company said it has notified the physicians' offices by telephone.
Meanwhile, the FDA urged consumers to contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using the drug product.
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