FDA believes Avastin was transferred from sterile vials into single-use syringes.
A cluster of serious eye infections in Miami prompted the FDA to issue an alert to health care professionals around the country.
Repackaged injections that go into the eye are the source of the infections.
Miami resident Esperanza Santiestaban has received several injections in her right eye to treat macular degeneration, and says she knew there was something wrong with the last one.
“It was a few hours after the injection. I started seeing little dots, a lot of dots and I lost the vision,” Santiestaban said. Her eye became very red, swollen and painful.
“We are representing six people who suffered similar catastrophic injuries as a result of this senseless and needless contamination,” said her attorney, Gary Alan Friedman.
According to the FDA, the drug Avastin was taken from sterile vials and repackaged into multiple single-use syringes distributed to several eye clinics, a process called compounding.
Investigators traced tainted Avastin injections to one pharmacy in Hollywood, the FDA said.
In at least one lawsuit related to the infections, InfuPharma compounding pharmacy in Hollywood was named. The owner would not comment because of pending litigation.
The cause of the infection is streptococcus, a strain of bacteria found in throats and noses. That strain was found in the eyes of twelve patients and seven unused syringes. All had the same bacteria and the same DNA, according to Dr. Harry Flynn of Bascom Palmer Eye Institute.
“We suspect somehow the moisture droplets from a person contaminated the medication during the compounding process,” he said.
All the infected patients were referred to Bascom Palmer Eye Institute for treatment. Doctors there have had years of experience with Avastin injections and say they have never seen anything like this.
“Given the fact that it occurred in four separate offices to three different ophthalmologists and the medications all arrived from one compounding pharmacy, you would say it’s probably not the doctors’ technique,” said Dr. Flynn.
Out of twelve patients seen with infections, ten have had serious vision loss and two have each lost an eye. Only two of the patients have had vision restored to what it was before the infection.
Santiestaban says she's been told there is no chance she will regain her vision.
She says she can’t even see a bright light in front of her eye, “and the doctor says if the pain continues, they have to remove the eye.”