FDA to Import Drugs for Critically Ill Premature Babies

The agency said Wednesday it immediately will begin importing trace elements, potassium phosphate and sodium phosphate -- drugs used in total parenteral nutrition or TPN -- from a Norwegian plant affiliated with Fresenius Kabi USA LLC, based in Lake Zurich, Ill.

"Hospitals can start ordering the drugs today," said Valerie Jensen, associate director for the FDA's drug shortage program.

That should start reversing a two-year shortage that has forced hospitals to ration the drugs that provide essential nutrients for patients who can't eat or drink by mouth, said Jay Mirtallo, past president of the American Society for Parenteral or Enteral Nutrition, or ASPEN.

"I think it's huge. It's a great win for us," said Mirtallo. "For too long, we've been limping along trying to feed our patients."

Without adequate TPN drugs, tiny babies and other patients can develop severe side effects, including horrifying skin lesions and deficiencies that can demineralize their bones, leading to fractures, experts say. Some may have lasting developmental delays caused by missing nutrients.

The FDA is exercising regulatory discretion in allowing the drugs to be imported. When the agency turns to a foreign source, as it has for 14 other drugs in the past two years, officials evaluate the foreign drugs to make sure quality is adequate and does not pose undue risk to U.S. patients, officials said.

The move comes after 14 U.S. senators demanded earlier this month that the FDA act to end the shortage of infant drugs.

Image: Premature baby in a NICU, via Shutterstock

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