On behalf of Kaiser Gornick LLP posted in Dangerous Pharmaceuticals on Friday, December 14, 2012
Bevacizumab injections prepared by a Florida compounding pharmacy blinded almost a dozen patients according to news reports. The patients were given bevacizumab, also known as Avastin to treat various eye diseases. Out of the 12 patients who received the bevacizumab shots, all but one lost vision in the effected eye.
Seven of the patients lost their eyes completely due to endophthalmitis, which is a severe inflammatory reaction to bacteria. Endophthalmitis can develop quickly, and most of the 12 patients turned up in Miami emergency rooms within 48 hours of receiving the injections.
Investigators say that all of the bevacizumab injections were prepared by the same compounding pharmacy. The defective pharmaceuticals were contaminated with Streptococcus mitis or oralis, which are bacteria commonly found in human mouths.
FDA research into the compounding pharmacy found dirty lap equipment, leaking boilers and inadequate monitoring or testing of sterile equipment. This is one of several high profile compounding lab-caused outbreaks in the states this year. MedPage Today reports that 33 fungal infections were linked to injections made by another compounding lab in Ocala, Florida.
One ophthalmologist said that his profession is highly reliant on these compounding labs to make all preservative-free formulations and intravitreal antibiotics, so these outbreaks are deeply concerning.
“So to some extent we need to figure out ways to safely prepare these medications,” he said. “And it obviously begs the question that’s been the main story here — how to best ensure medications that pass through compounding pharmacies are safe.”
Source: MedPage Today, “Compounder tied to tainted eye meds,” Kristina Fiore, Nov. 15 2012