Summary Safety Review - Amino-acid solutions for parenteral nutrition - Assessing the potential risk of death in premature infants when the solutions are not protected from light

July 6, 2017

Product

Amino-acid solutions for parenteral (intravenous) nutrition

Potential Safety Issue

Deaths in premature infants when the solutions are not protected from light

Key Messages

  • Amino-acid solutions for parenteral (intravenous) nutrition (PN) are authorized for sale in Canada to provide nutrition through a vein. Some of these are used to feed premature infants.
  • Health Canada reviewed the risk of death in premature infants when fed with amino-acid solutions for PN that are not protected from light while being used because of published studies that suggested light exposure increases the risk of harm.
  • Health Canada’s review of the available information did not establish a link between the risk of death in premature infants and the use of amino-acid solutions for PN that have not been protected from light while being used. Health Canada will continue to monitor the safety of these products and encourages healthcare professionals to report side effects that may be linked to the use of these products.

Overview

Health Canada reviewed the risk of death in premature infants when fed with amino-acid solutions for PN that are not protected from light because of published studies that suggested greater risk of harm with these conditions. The studies discuss the possibility that light exposure can cause harmful chemicals (including toxic peroxides) to be made within the PN solution that the infant’s body would not be able to process. Oxygen therapy, receiving blood (blood transfusions) and infections both in the infant and the mother may also play a role in the production of these harmful chemicals.

Use in Canada

  • Amino-acid solutions for parenteral nutrition (PN) are authorized for sale in Canada to provide nutrition through a vein (intravenous). Premature infants are not developed enough to digest food in their gut and PN can help meet their feeding needs.
  • Amino-acid solutions for PN that are available in Canada include the following products: Primene, Prosol, Clinimix, Olimel, Travasol, Smofkabiven and Aminosyn.
  • Other than Primene, these products are not specifically authorized to be used in infants or children.
  • The product information for the above amino-acid solutions (except for Olimel and Smofkabiven) state that they should be protected from light during storage, but do not mention about protection from light when the solutions are being used.

Safety Review Findings

  • At the time of the review, Health Canada received 5 Canadian reportsFootnote a of deaths in premature infants, suspected to be related to the use of PN. All of these reports involved Primene. None of the reports included information on whether or not the solutions were protected from light while being used.
  • In addition, 13 international reports that involved premature infants were received from manufacturers. All of these reports involved Primene. None of the reports included information on whether or not the solutions were protected from light.
  • In the review of the 18 reports, 10 reports showed that the cause of death was not due to the light exposure of the PN solutions as these infants died from common causes of death associated with being born prematurely. In the remaining 8 reports, it was not possible to assess the link between the deaths and light exposure of the PN solutions because not enough information was provided.
  • A published articleReference 1 assessed 4 individual studies together (a meta-analysis) regarding premature infants being fed with amino-acid solutions for PN and concluded that there is a greater risk of death associated with the use of PN solutions that are not protected from light. However, there were differences noted in each study. The quality of the amino-acid solutions, the number of days the infants were given PN, the health outcomes of interest (e.g. diseases that premature infants are likely to get) and medical practices (e.g. oxygen therapy or receiving blood) varied among the studies. In addition, there was limited or no information on other risk factors such as infections, the age of the infants at the time of death, medications and therapy that may have been used at the same time, and the causes of death.
  • Another articleReference 2 was reviewed which assessed information from the Canadian Neonatal Network about premature infants receiving PN. It concluded that protecting the amino-acid solutions for PN from light does not lessen the risk of side effects or death.

Conclusions and Actions

  • Health Canada’s review of the available information did not establish a link between the risk of death in premature infants and the use of amino-acid solutions for PN that have not been protected from light.
  • Health Canada encourages healthcare professionals to report side effects related to the use of these health products.
  • Health Canada will continue to monitor safety information involving parenteral nutrition solutions, as it does for all health products on the Canadian market, to identify and assess potential harms. Health Canada will take appropriate and timely action if and when any new health risks are identified.

Additional Information

The analysis that contributed to this safety review included scientific and medical literature, Canadian and international information and what is known about the use of these products both in Canada and internationally.

For additional information, contact the Marketed Health Products Directorate.

 

 

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