Thank you to the lawyers Parke Waichman for their professionalism, especially to Jorge Peniche, a person who was of great help to me in several aspects, very grateful, thank you again.....
Josue Portillo
5 years ago
The U.S. Food and Drug Administration (FDA) just announced that Clinical Specialties recalled 79 lots of Avastin (bevacizumab) unit dose syringes, over the potential for serious eye infection. The recalled Avastin has, or could potentially, lead to an infection in the eye; Clinical Specialties, a compounding pharmacy, has received reports of five intra-ocular infections. It […]
The U.S. Food and Drug Administration (FDA) just announced that Clinical Specialties recalled 79 lots of Avastin (bevacizumab) unit dose syringes, over the potential for serious eye infection.
The recalled Avastin has, or could potentially, lead to an infection in the eye; Clinical Specialties, a compounding pharmacy, has received reports of five intra-ocular infections. It was these reports, from a physician’s office, that led to the problem being identified.
The Avastin unit dose syringes were being used solely as an off-label use by ophthalmologists in the treatment of macular degeneration. The drug is packaged in sterile syringes and is meant to be administered by a licensed physician in a surgery or physician’s office setting. Syringes were distributed to doctors’ offices in Georgia, Louisiana, South Carolina, and Indiana from December 18, 2012 to present.
The agency recommends that doctors in possession of the recalled Avastin stop using the drug immediately. Clinical Specialties may be reached, toll-free, at 1.866.880.1915 or by email to clinicalrx@bellsouth.net. The compounding pharmacy is available Monday through Friday from 10:00 a.m. to 5:00 p.m., Eastern Standard Time (EST). A complete list of the lots involved may be accessed on the FDA web site here.
Avastin, which is manufactured by Genentech, is an injectable cancer medication that works by blocking a protein important for the formation of blood vessels. Tumors rely on blood vessels to receive the nutrients they need to survive; Avastin is believed to work by preventing the formation of new blood vessels that feed the tumor and is approved to treat brain, colorectal, lung, and kidney cancers.
Avastin has long been used off-label to treat wet, age related macular degeneration and as an alternative to the much more costly drug, Lucentis.
We previously wrote that several clusters of blinding eye infections had some doctors re-thinking the common practice of using Avastin off-label to treat wet, age-related macular degeneration. Physicians cited medical malpractice lawsuit fears.
Both Avastin and Lucentis are made by Genentech, and work in a similar manner. But as we’ve said, while Avastin only costs around $50/dose, Lucentis comes in at around $2,000/dose.
Avastin is sold in larger doses and, in order to be used for eye injections, Avastin must be repackaged, or compounded.
When the drug is divided into smaller doses, usually by a compounding pharmacy, bacterial contamination can occur. This was tragically seen in the recent fungal meningitis outbreak that killed scores and sickened hundreds following injections with medications compounded by the New England Compounding Center (NECC).
The FDA issued a prior alert after Avastin eye injections prepared at one Hollywood, Florida, pharmacy were linked to a cluster of blinding eye infections in the Miami area. Avastin eye infection clusters were also reported at Veterans Administration facilities in Tennessee and Los Angeles, California.