Soon after reports of eye infections from tainted Avastin syringes prompted Clinical Specialties to recall the product, the Food and Drug Administration alerted the Georgia-based pharmacy to expand their effort to include all lots of sterile products.
"The recall of all sterile products is conducted in follow-up to concerns regarding practices at the site which cannot assure the sterility of the products," FDA stated on Thursday.
Unapproved Avastin syringes were recalled from the pharmacy in Georgia after the FDA reported five patients had developed intra-ocular infections.
The drug was being used to treat age-related macular degeneration, or AMD, a loss of vision that commonly occurs in people ages 50 and up.
Clinical Specialties Inc., the compounding pharmacy based in Augusta, Ga., was responsible for distributing Avastin syringes to medical offices in Georgia, Louisiana, South Carolina and Indiana. Compounding pharmacies customize medication for patients based on doctor's approval.
When the pharmacy received reports of eye infections, they voluntarily began recalling the off-label drugs. So far, nearly a dozen people contracted an eye infection, four of them from Tennessee. Some individuals even became blind, reported NBC.
"The patients have developed bacterial endophthalmitis caused by streptococcus bacteria," Cherie Dreznek, the state epidemiologist of Georgia, tells NBC. "Food and Drug Administration officials warned health care workers in August 2011 about the dangers of using repackaged eye injections of Avastin, a cancer drug known generically as bevacizumab."
Avastin is approved to treat certain cancers of the colon, lung, kidney and brain.
"Although there has been no evidence of contamination with sterile products other than the specified Avastin lots, Clinical Specialties has decided in the interest of their patients to proceed with this recall process," the FDA stated.
Among the recalled sterile products, cataract and otheropthalmic drops were included. Health officials warn that endophthalmitis is an infection that begins inside the eyeball and is especially deleterious after an intravitreal injection and could lead to permanent blindness.
Avastin is marketed by Roche, but being distributed into smaller inexpensive units at pharmacies for AMD patients. The syringes were dispersed for the four states on Dec. 18, 2012; those that were sold in Clinical Specialties were distributed between Oct. 18 and March 19, 2012.
Compounding pharmacies became the center of debate in December when a deadly fungal meningitis outbreak killed 39 people and sickened 620 others.
The FDA officials and state representatives had convened that winter to discuss a regulatory framework for compound pharmacies but little progress has been made to create a concrete legislation.
Published by Medicaldaily.com