About 200 cancer patients at 13 public hospitals in Ireland have been offered medical consultations over concerns that chemotherapy treatments they received may have been contaminated.
The Irish Times reports that HSE says the move is precautionary and there is no indication “at this time” from the drug manufacturer that treatments have been affected.
Fannin Compounding in Dublin issued an alert after finding a machine used to manufacture the treatment was contaminated with bacillus cereus, a bacteria which can cause serious gastro-intestinal infections and which has been found to affect people with lowered immune systems.
The HSE was notified last week of a precautionary recall of a number of batches of chemotherapy drugs manufactured by the compounding pharmacy between September 29th and October 12th.
“The company stated that a potential drug sterility issue was detected during routine daily tests that occur as part of their quality assurance processes.” stated HSE.
“All patients involved have now been contacted and offered an appointment. However, if in the interim, any of these patients experience any unexpected symptoms differing from what they normally experience after treatment, they are being advised to attend at or/and contact their treating hospital.”
The hospitals involved are: Connolly Hospital in Blanchardstown; Our Lady of Lourdes Hospital Drogheda; Rotunda Maternity Hospital; South Tipperary General Hospital; St Luke’s General Hospital Kilkenny; St Luke’s Radiation Oncology Network, Rathgar; Bantry General Hospital; Beaumont Hospital; Royal Victoria Eye and Ear Hospital; Naas General Hospital; Portiuncula Hospital in Ballinasloe; South Infirmary Hospital in Cork; and St James’s Hospital.
The Health Products Regulatory Authority, which licensed the Fannin to compound medical products at its plant in Sandyford, Co Dublin, says there is no evidence at this time to suggest an issue with any of the medicines recalled.
The authority said the problem was identified when the company carried out its daily assessments of the manufacturing process using a test product to detect potential contamination, and that a contaminated test product does not automatically mean that the medicines produced are affected. A contamination was noted with the test product on October 12.
Because the test product must be incubated for two weeks to identify any contamination, as a precaution all units manufactured from September 29 the were recalled.
“As of today (October 16th) the 14 day incubation period for the test products produced up to October 2nd has been completed successfully and no contamination has been found. This means that 132 of a total of 297 units filled over the 14 day period are not implicated. Additionally, 45 unused units have been recovered.”
The Irish Times reports that the equipment used to make the products has been taken out of use during the investigation. Fannin Compounding alerted oncologists last week that it recalled the treatment and has since identified the source of the contamination.