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FDA to import scarce nutrition drugs for sickest babies

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 can’t 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 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. 

But some drug shortage experts worry that the supply won’t 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. 

“Yes, there is a bit of imported product, but not enough to resolve the shortage,” said Erin Fox, manager of the University of Utah Drug Information Service, which tracks shortages.

Indeed, quality problems continue to plague many U.S. drugmakers, including Fresenius Kabi. Within minutes of the FDA's formal announcement of the import agreement on Wednesday, the agency also posted a notice saying that Fresenius was initiating a voluntary recall of one lot of magnesium sulfate injection because of the potential for the product to be contaminated with glass particles. 

About 370,000 patients discharged from U.S. hospitals in 2010 received TPN, according to figures from ASPEN. About a third were pediatric patients and a third were elderly. There are likely a couple hundred thousand patients who receive TPN on an ongoing basis at home. 

The number of new drug shortages in the U.S. is way down this year: only 54 at the end of April compared with a high of 267 in 2011. But the number of active shortages, including injectable trace elements, is 300, a peak, Fox indicated.

The Norwegian plant also will serve as a back-up to help with shortages of other critical drugs, Jensen said. Increased supply from U.S. makers already has helped ease a shortage of injectable zinc that caused severe diaper rash, blistering skin lesions and other problems in very premature babies in Washington, D.C., and Texas. 

Children’s Hospital of Colorado is one of the sites across the country that has been grappling with ongoing shortages of TPN drugs, said Jerrod Milton, chief pharmacy officer.

“To be honest, we’ve been past the critical point for some time,” he said. News that the FDA had found a new source for the drugs would be welcome relief, he added.

“We’re always waiting and watching and hoping that the FDA will intervene.”

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