FDA to import scarce nutrition drugs for sickest babies

By JoNel Aleccia, Senior Writer, NBC News

Food and Drug Administration officials have turned to Norway to help ease a shortage of injection drugs used to provide nutrition to critically ill premature babies and cancer patients who cant eat any other way.

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 FDAs 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 cant eat or drink by mouth, said Jay Mirtallo, past president of the American Society for Parenteral or Enteral Nutrition, or ASPEN.

I think its huge. Its a great win for us, said Mirtallo. For too long, weve 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.

But some drug shortage experts worry that the supply wont be enough to satisfy the shortages that stem largely from the shut-down of a U.S. drug manufacturer, American Regent. The firm was plagued by ongoing quality control problems -- including glass and other particles in products -- dating back to 2011. The plant was shuttered temporarily at the end of 2012 and has been working to get back online.

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FDA to import scarce nutrition drugs for sickest babies