FDA allows imports of IV infant drugs in critical shortage

Federal health regulators are allowing imports from overseas of critical intravenous drugs used to nourish premature infants, amid a shortage that has affected hospitals nationwide.

The Food and Drug Administration said Wednesday new supplies of drugs used in total parenteral nutrition, a ubiquitous hospital staple, will be available to U.S. patients this week. The injectable formula is used to feed newborn infants, cancer patients and other vulnerable groups who are unable to eat or drink by mouth.

"If they cannot eat anything by mouth they have to be provided intravenous nutrition or they'll starve to death in a very short period of time," said Jay Mirtallo, professor of clinical pharmacy at Ohio State University. While the formula is most critical for infants, he said that "we have patients from 2 years old to 90 years old who are on it."

The solution contains trace drug ingredients, including potassium phosphate, which have been in short supply.

FDA officials said they are temporarily allowing imports of those ingredients from a plant in Norway to ease shortages triggered by the shutdown of American Regent, the primary U.S. manufacturer.

American Regent halted operations late last year to fix contamination issues uncovered by FDA inspectors. Regulators found a number of problems at the company's Shirley, N.Y., facility, including specks of matter floating in injectable drugs.

FDA officials said the agency has inspected the Norway facility operated by Fresenius Kabi, a top maker of infused medicines, and confirmed that it meets U.S. manufacturing standards.

"We believe the import of these injectable nutrition drugs will meet patient needs over the coming weeks - but initially hospitals should just order what they need at this time," Valerie Jensen, associate director of the FDA's drug shortages program, said in an interview with The Associated Press.

Drug shortages have increased dramatically in the U.S. over the past six years, particularly for inexpensive generic injected drugs, including powerful antibiotics, painkillers and anesthetics used in surgery. They are the workhorses of hospitals but are difficult to make and produce little profit for drugmakers.

Some cancer drugs also have been in short supply, disrupting both treatments that require medication administered on a precise schedule and patient tests comparing existing drugs with potential new treatments.

Read the original here:
FDA allows imports of IV infant drugs in critical shortage