Study links IV feeding bags to liver problems

WASHINGTON (July 29, 5:15 p.m. ET) -- A study by doctors at a German hospital suggests that the use of intravenous feeding bags that contain a well-known phthalate can increase the risk of liver problems in premature babies. But the chemical industry counters that the study did not look at all the potential contributing factors and dismissed other factors that could have contributed to the different results between the two test groups.

"You have to challenge the conclusions based on the data that was presented,” said Steve Risotto, senior director of the Phthalates Ester Panel of the American Chemistry Council in a phone interview July 29. “The data is not highly reliable, they didn’t look at all the factors, and they didn’t make a cogent argument as to the cause-and-effect.”

The study, published July 27 in the medical journal Pediatrics found that 15 of the 30 infants who received parenteral nutrition through IVs that contained DEHP developed signs of cholestatic jaundice compared to just six of the 46 who received the same care through DEHP-free IVs. DEHP is the acronym for Di(2-ethylhexyl) phthalate.

But there were differences in treatment that were not taken into account in the conclusions.

For example, the infants in the phthalate group received treatments that lasted longer — 26.23 days vs. 22.2 days for the non-phthalate group. In addition, the phthalate group received an average of 16.6 treatments, or nearly five times as many as the non-phthalate group, which received an average of only 5.6 treatments.

“There is a higher incidence,” said Risotto, ‘But the study didn’t take into account other factors that could have contributed to that,” such as more treatments and treatments of longer durations. He said that the study also dismissed “in non-defensible ways” two other factors — surgical interventions and systemic infections — that even the study said increases the risk of contracting cholestatic jaundice.

The study calculated that systemic infections can cause a fivefold increase in the risk of developing cholestasis and that surgical conditions that require surgical interventions can increase that risk 33.8 fold.

But, without any explanation, the study dismissed the potential increased risk that could be caused by systemic infections as “statistically not significant.” Likewise, it ignored the risk factor from surgical interventions and said that a 5.6 fold increase in risk for hepatobiliary dysfunction from the use of IVS that contain DEHP was “statistically significant,” again without supporting data.

“There is a lot that they didn’t explain,” Risotto said. “They dismissed two other factors that they said can contribute to the development of cholestasis without any data” to support their hypothesis. “It took a great leap of faith on their part to say DEHP is the cause.”

Risotto also said the study did not measure DEHP exposure, and that there was no discussion in the study of what types of drugs were administrated to the premature babies. That is an important omission, he said, because drugs, particularly penicillin-derived drugs, can increase the risk of contracting cholestasis.

Phthalates are used to soften chemicals and are commonly found in bath toys, teethers and bibs.

The Consumer Product Safety Improvement Act, signed into law in August, banned, as of this past Feb. 10, the sale of toys intended for children 12 or younger, or child-care articles for children 3 and under, when the toys contain more than 0.1 percent of any of three types of phthalates: DEHP, dibutyl phthalate and butyl benzyl phthalate.

The law also places a temporary ban on any toy or child-care article that can be placed in a child's mouth and chewed and contains more than 0.1 percent of three other phthalates — diisononyl phthalate (DINP), diisodecyl phthalate and di-n-octyl phthalate — until a scientific advisory panel review is completed. At that time the temporary ban could be made permanent or lifted. DINP is the phthalate most commonly used as a plasticizer for toys.

Under the law, CPSC has three years to review and keep or lift the temporary ban.

The European Union has had a ban for the last 10 years on the use of those six phthalates in mouthing toys that are about 2 inches or less on each side. There are similar bans in Argentina, Japan, Israel and Mexico. 

California and Washington also have similar phthalate bans that went into effect this year.

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