Health chiefs have launched an urgent probe
after one baby died and fourteen more were left fighting for life after
being poisoned by contaminated drips.
The vulnerable babies, who were all in
intensive care in neonatal units, developed septicaemia after being
infected with bacteria in their food.
The bug – called Bacillus cereus – causes
blood poisoning and was fed to mainly premature babies who are extremely
vulnerable to infection.
Public Health England (PHE) said the cases
have been “strongly linked” with a number of batches of a particular
form of intravenous liquid called parenteral nutrition, which was given
to the babies.
The liquid, manufactured by ITH Pharma
Limited, is supposed to deliver a variety of nutrients intravenously
when a baby is unable to eat on their own.
A PHE spokeswoman said that investigations
with the company have identified “an incident that might have caused the
contamination”.
The affected babies were in neonatal
intensive care units at three London-based NHS organisations – Chelsea
and Westminster NHS Trust, Guy’s and St Thomas’ NHS Foundation Trust and
The Whittington Hospital – as well as Brighton and Sussex University
Hospitals NHS Trust, Cambridge University Hospitals NHS Foundation Trust
and Luton and Dunstable University Hospital.
But officials have not confirmed which unit was treating the baby who died.
“Many of the babies were premature and very
vulnerable and one baby has sadly died but the others are responding to
antibiotic treatment,” the spokeswoman said.
She said that PHE and Medicines and
Healthcare products Regulatory Agency (MHRA) confirmed that an
investigation has been launched into the issue.
The manufacturer has issued a recall and the MHRA has issued an alert to draw attention to the product recall.
PHE said that doctors have also been given
advice on identifying any potential cases of infection and how to
dispose of affected stock.
“This is a very unfortunate incident and PHE
have been working closely with the MHRA to investigate how these babies
could have become infected,” PHE’s incident director, Professor Mike
Catchpole, said.
“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 the 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.”
Adam Burgess, manager of the MHRA’s defective
medicines reporting centre, said: “Patient safety is our top priority
and we are working alongside PHE to establish what has happened. We have
sent inspectors to the manufacturer’s facility to carry out a detailed
and rigorous inspection and we have ensured that the potentially
affected medicine is recalled.”
London-based ITH Pharma Limited was not available for comment tonight.
But on its website it boasts how it has set “new standards of reliability in the industry”.