MHRA says investigations with the company have identified an incident that might have caused the contamination
The London-based manufacturer of intravenous baby food that is 'strongly linked' to 15 cases of blood poisoning in which one baby died, has said it is 'saddened' by what has happened.
ITH Pharma, a provider of compounding aseptic services for all therapy areas, said it is cooperating fully with an inquiry by Public Health England (PHE) and the UK's Medicines and Healthcare products Regulatory Agency (MHRA).
The blood poisoning (septicaemia) was caused by a bacteria known as Bacillus cereus. The affected babies are in neonatal intensive care units at a small number of hospitals in England.
Many of the babies were premature and very vulnerable and the baby which died was at St Thomas' Hospital in London.
The others, at Chelsea and Westminster NHS Trust (4 cases); Guy’s and St Thomas’ NHS Foundation Trust (2 cases); The Whittington Hospital (1 case); Brighton and Sussex University Hospitals NHS Trust (3 cases); CUH Addenbrookes (Cambridge University Hospitals) (2 cases); and Luton and Dunstable University Hospital (2 cases) are responding to antibiotic treatment.
The PHE and MHRA said investigations are ongoing but so far indications show that the cases have been 'strongly linked with a number of batches of a parenteral nutrition which was given to the babies in liquid form'. This contains a variety of nutrients that are delivered directly into the babies’ bloodstream when they have problems ingesting food through their mouths.
Investigations with the company have identified an incident that might have caused the contamination
This type of nutrition is manufactured under strictly controlled aseptic conditions. 'Investigations with the company have identified an incident that might have caused the contamination,' the MHRA said.
Investigations into this are ongoing and inspectors are visiting the manufacturing plant at Park Royal, NW London.
The product has a short shelf life and although 'it is unlikely that any stock from the day of contamination incident remains (it expired on 2 June)', the MHRA has issued a Class 1 drug alert to support the manufacturer’s recall of the product on 4 June.
Although the affected product was only issued to a limited number of neonatal units an alert has been issued to all neonatology units across the UK to make them aware of the incident.
PHE said doctors have been given advice on identifying any potential cases of infection and how to dispose of affected stock.
Bacillus cereus is found widely in the environment in dust, soil and vegetation. Most surfaces would be likely to test positive for the presence of the bacteria. Bacillus cereus produces very hardy spores and in the right conditions these will grow. The spores can produce a toxin which causes illness.
Professor Mike Catchpole, PHE incident director, said: 'This is a very unfortunate incident and PHE has been working closely with MHRA to investigate how these babies could have become infected. Given that the bacteria is widely spread in the environment we are continuing to investigate any other potential sources of infection.
'However, all our investigations to date indicate that the likely source of the infection has been identified. We have acted quickly to investigate this issue alongside MHRA and we have taken action to ensure that the affected batches and any remaining stock of this medicine is not being used in hospitals.'