Magazine article Drug Topics

Groups Support TPN Proposal but Make Recommendations

Magazine article Drug Topics

Groups Support TPN Proposal but Make Recommendations

Article excerpt

A proposal by the Food & Drug Administration to set aluminum levels and include warning labels on certain total parenteral nutrition (TPN) solutions has elicited agreement from most industry groups. The FDA proposed an upper limit of aluminum permitted in large-volume parenterals to 25 mcg per liter after it reviewed evidence linking the use of parenteral drugs with aluminum to TPN patient deaths.

There were, however, some suggestions for change. "It is highly desirable for FDA to implement such a rule as a first step toward limiting aluminum content of small-volume parenterals," the American Society for Parenteral & Enteral Nutrition (ASPEN) and the American Society for Clinical Nutrition (ASCN) wrote to the FDA. The groups recommended that:

Aluminum content in small-volume parenterals should be initially restricted to the lowest published levels. The FDA did not require the restriction in the proposed rule, because a safe lower limit has not been established. …

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