FDA takes action to ease neonatal drug shortage
NEW YORK — Federal health regulators are allowing imports of critical intravenous drugs used to nourish premature infants, amid a shortage that has affected hospitals nationwide.
The Food and Drug Administration said Wednesday that new supplies of drugs used in total parenteral nutrition, a ubiquitous hospital staple, will be available to US 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 US 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 and confirmed that it meets US manufacturing standards.
Drug shortages have increased dramatically in the United States 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 drug makers.
Some cancer drugs also have been in short supply.
Deaths and injuries caused by the shortages aren’t tracked by any government agency, but the AP documented 15 related deaths in the 15 months through September 2011. They were caused either by hospitals having to use a less-effective treatment or by dosing errors or other problems.
Since 2010, the FDA has allowed the importation of 14 drugs to combat US shortages. Wednesday’s action will bring that number to 17.