No reports of adverse reactions have been received from patients at the centre of a contaminated chemotherapy scare, or from their doctors, according to the Health Products Regulatory Authority.
The authority says the number of cancer patients potentially at risk of having received contaminated chemotherapy from Fannin Compounding has fallen to eight.
All of these patients received product on October 8th, the day a problem was identified with the treatments made at the company’s plant at Sandyford, Co Dublin.
A test product was found to be contaminated with bacteria that can cause serious gastro-intestinal infections.
The authority has completed its precautionary recall action of chemotherapy medicines compounded at the plant over a two-week period. As a result of this action, the number of potentially contaminated units has reduced to eight, so 289 of the original 297 units examined are now deemed free of risk.
Unused medicines
This figure includes unused medicines which were recalled as well as units which have passed the 14-day incubation period for testing.
The problem was identified when a test product, which is not administered to patients, showed signs of contamination on October 8th, four days after the matching units of chemotherapy were identified.
The authority says evidence of contamination in the test product is not evidence of contamination of the chemotherapy. “The HPRA has not received reports of any adverse events associated with these medicines.”
Last Friday, it emerged the company issued an alert after finding a machine used to manufacture chemotherapy drugs was contaminated with the bacteria, bacillus cereus.
Originally, almost 200 patients in 18 public and private hospitals were affected when news of the problem emerged. These have been contacted by their oncology team since then.
The HPRA says it is continuing to investigate the incident at Fannin and to liaise with the HSE on the matter.
The isolator used to compound the product remains out of operation, as does a second machine that was the subject of an earlier recall.
