Seoul, Jan. 12 (Korea Bizwire) — New details have emerged regarding the deaths of four premature infants at Ewha Womans University Medical Center’s neonatal intensive care unit, which paints not only the medical staff involved but the Ministry of Food and Drug Safety, the National Forensic Service, and other health authorities in a damning light.
The Seoul hospital has been mired in scandal ever since the four babies died due to then unknown circumstances. After a lengthy investigation carried out by the National Forensic Service (NFS), police issued a statement earlier today revealing the cause of death to be blood poisoning brought about by the bacteria Citrobacter freundii.
However, a discovery regarding the intravenous substance Smoflipid that was administered to the newborns has cast doubt on the NFS investigation.
On the United States’ Food and Drug Administration website, the medicine guide titled “SMOFLIPID (lipid injectable emulsion)”, has at the top of the first page “WARNING: DEATH IN PRETERM INFANTS”, with a bullet point underneath that says: “Deaths in preterm infants have been reported in literature”.
This document includes information that the injection of soybean-based intravenous liquid emulsions in preterm infants’ veins has proven to be fatal. Furthermore, it states that autopsies performed on the dead infants discovered an accumulation of lipids in the pulmonary arteries.
Also pointing out that the presence of Smoflipid in both preterm and low birthweight babies was irreversible once administered and led to increased levels of free fatty acid plasma levels, the FDA in its document emphasized that neither the substance’s efficacy nor its safety for preterm infants had yet been proven.
Worryingly, the FDA’s medicine guide states preterm infants are at risk of possible kidney damage from the aluminum contained in Smoflipid due to their need for multiple doses.
Despite the concerns laid out by the FDA, the Smoflipid guide from South Korean authorities bears no mention of these issues.
Though the Ministry of Food and Drug Safety’s medicine guide does instruct physicians to “proceed with caution” when administering the IV to premature newborns suffering from hyperbilirubinemia and pulmonary hypertension, nowhere does it state that “Deaths in preterm infants have been reported in literature”.
It appears that experts in the field are uninformed regarding this omission. One pediatrics professor at a university hospital spoke with Yonhap News and admitted his ignorance. “I was unaware that there was a warning that Smoflipid could potentially be fatal for premature newborns. It must be that the FDA added this information to its medicine report, but the Ministry of Food and Drug Safety’s medicine guide didn’t add it to theirs.”
The news has caught the police unawares. A high-ranking member of the police said law enforcement would “look into the matter” after saying that “we were frankly unaware until now how different the FDA and the Ministry of Food and Drug Safety’s medicine guides were.”
Another medical instructor at a university hospital said that the investigators may, in their ignorance, have completely failed to account for the role Smoflipid played in the disaster. The individual, who asked not to be named, stressed that should this be the case, the investigation should be reopened.
The instructor added that the use of Smoflipid in NICUs across the country should at least temporarily be halted until the extent of its dangers are verified.
“Most likely, there are hospitals that are still administering Smoflipid to premature babies,” the individual said.