Warning to 200 patients of chemotherapy drug risk

Approximately 200 cancer patients have been warned they may have been given potentially contaminated chemotherapy drugs.

The Health Service Executive said it was notified this week of a “precautionary” recall of a number of batches of chemotherapy drugs manufactured between September 29 and October 12.

However, one woman being treated for cancer told RTÉ’s Liveline yesterday she had been advised on Thursday that she may have been treated with contaminated product the previous day.

A man, who also contacted Liveline yesterday, said his wife, who had chemotherapy treatment last Thursday, was contacted on Tuesday to say the drug she received may have been contaminated.

He wondered why there was no public alert about the issue before he contacted Liveline.

There are 13 hospitals involved in the recall, including two in Cork — Bantry General Hospital and South Infirmary Hospital.

Fannin Compounding in Dublin issued a product recall on Monday after finding bacteria in one of its chemotherapy isolators, a machine used in the manufacturing process.

The bacteria — bacillus cereus, that can cause serious gastrointestinal infections — was discovered during routine testing.

Cancer patients are at particular risk of becoming ill because their immune systems are low.

National Cancer Control Programme director, Dr Jerome Coffey, said the company contacted the hospitals directly to alert them that their quality assurance process had malfunctioned.

Fannin Compounding contacted the Health Products Regulatory Authority (HPRA) before notifying oncologists that it had identified the source of the contamination.

The company that has had three product recalls in the last six months said it regretted any upset it had caused to patients.

The HSE said it was decided “on a precautionary basis, that patients who received the drugs should be contacted by their treating hospitals”.

It said any patient who received the medicine had been contacted but stressed that there was no indication to date that any drugs given to patients had been contaminated.

The patients were informed about the potential contamination risk and offered appointments to meet their clinical teams to discuss any possible concerns.

Fannin Compounding said the recall related to a sterility assurance issue. Their investigations were continuing as to how the issue arose and immediate corrective actions had been implemented, including taking the isolator in question out of use.

The HPRA said there was no evidence, at this point, to suggest an issue with any of the medicines recalled.

The medicines’ watchdog said the the contaminant had been identified and the hospitals concerned had been contacted so prescribers could choose the best treatment if a patient was infected.

The HPRA director of compliance, John Lynch, said they had no reports of side-effects of any of the patients that could be related to a product being contaminated.

A test product, produced daily must be incubated for 14 days to identify any contamination and therefore, as a precaution, all units manufactured from September 29 were recalled.

“At this stage we have no indication that the products are contaminated. We are talking about test product that has remained back at the facility,” Mr Lynch said on RTÉ news last night.

Mr Lynch said that the company had issued three precautionary recalls in the last six months and agreed it was a worrying time for patients.

Anyone with concerns can contact the Irish Cancer Society at freefone 1800 200 700 to speak to an nurse for support and information.

See More At: http://www.irishexaminer.com/ireland/warning-to-200-patients-of-chemotherapy-drug-risk-359865.html

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