Tokyo Women’s Medical University Hospital said Thursday its outside panel has determined that its decision to use propofol on children against the advice of its maker might have contributed to the deaths of five children in its intensive care unit over the past six years.
The five were among 11 children who died after being administered the powerful sedative, which was at the center of pop star Michael Jackson’s death, while on ventilators in the hospital’s ICU.
The medicine’s inserts advise against using propofol when treating artificially ventilated children under 15 in ICUs, but the advice is nonbinding and doctors are left to use the drug at their discretion.
The children all suffered from serious heart disease, but the panel said it cannot deny the possibility that propofol influenced the direct causes of their deaths, such as infection or heart failure.
The panel also said the hospital might have disregarded the warning in the package inserts stating that long-term sedation of propofol in children is contraindicated.
A number of worldwide studies and publications limit the dosage to the maximum of 48 hours.
Eight of the 11 children who died after being sedated with propofol at the hospital not only included newborns and children under the age of 13 but were also treated for more than 50 days.
One child received the highest dose of the medicine for the longest period, 308 days.
But the panel has confirmed that none of the 11 cases was due to propofol-related infusion syndrome, a rare syndrome that occurs after the infusion, especially in patients undergoing long-term infusion for more than 48 hours. It often leads to a fatal cardiovascular collapse.
After the death of 11 children, in October 2012, the ICU instructed its staff about the warnings and stopped using the medicine on children younger than 15.
However, staffers working at the hospital’s seven other ICUs were not given the instructions and continued treatment using propofol on children.
After the death in February of a 2-year-old boy who was given propofol at one of the ICUs came to light, the hospital announced that it had used the medicine on 63 children between 2008 and 2013, out of which 11 deaths were presumed to be related to the use of propofol.
The hospital asked an outside panel to investigate the cases of the 11 children.
“If other ICUs were aware of the contraindication, death of the 2-year-old boy could have been avoided,” said the hospital’s deputy director, Kazuhiko Hayashi.
The hospital’s handling of bereaved families of the 11 children also brings its credibility into question, given that the families were told their children had been treated with propofol for the first time last June in a report concerning the child’s treatment.
“We haven’t been given any proper explanation, which makes us lose trust in its service,” said Akira Kawai, 52, a Tokyo resident whose 11-year-old daughter, Shiori, died in 2009, only two months after she had been hospitalized for surgery. She was diagnosed with dilated cardiomyopathy in 2008.