FDA takes action to ease neonatal drug shortage

[May 30, 2013]  WASHINGTON (AP) -- 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.

Deaths and injuries caused by the drug shortages aren't tracked by any government agency, but The AP documented 15 related deaths in just 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 in administering or preparing unfamiliar alternative medications.

While once considered an extraordinary step, the FDA has been increasingly allowing imports from factories that don't normally ship to the U.S.

Since 2010, the agency has allowed the importation of 14 drugs to combat U.S. shortages. Wednesday's action will bring that number to 17, with the addition of three new drugs used in nutritional formula.

There are currently 129 drug shortages in the U.S., according to the FDA.

Consolidation among generic drug manufacturers, as well as manufacturers deciding to end production of marginally profitable drugs, has led to decreased capacity. However, the shortages are caused primarily by problems with sterility and other serious issues that have led to shutdowns of production lines and occasionally entire factories. Recalls of huge batches of some drugs due to contamination by bacteria, fungi and tiny glass or metal particles have exacerbated shortages.

Barely an hour after announcing the importation decision, the FDA reported that Fresenius Kabi USA, the German drugmaker's U.S. unit, is recalling a large batch of its magnesium sulfate injection because of "the potential presence of glass particles" in the vials in which it was shipped. The product is used to treat magnesium deficiency and to prevent and control seizures caused by severe toxemia, a complication in about 5 percent of pregnancies that can harm or kill the mother and fetus.

A news release from Fresenius said there have been no reports of patient harm so far. It said particles were visible in some vials, and that glass particles in injectable drugs could cause life-threatening blood clots or block off small blood vessels.

The drug shortages force pharmacists at hospitals and clinics to spend considerable time trying to find supplies of crucially needed medicines. The problem also is adding millions of dollars to the cost of patient care, as some unscrupulous secondary drug wholesalers have been price-gouging hospitals, first hoarding supplies of scarce drugs and then charging astronomical prices for normally inexpensive generic medicines the hospitals cannot get from their regular suppliers.

Under a law passed last year, all drug manufacturers must notify the FDA of any production changes that could lead to drug shortages. Meanwhile, FDA officials say they are working with manufacturers to fix underlying problems with quality control and contamination that are responsible for the wave of shortages.

"In the near term companies are letting us know about these problems early on, which is good news," said Jensen. "Over the longer term we're hoping we'll have a safer drug supply as these companies upgrade and modernize their facilities."

Jensen said American Regent is in the process of resuming drug operations, but because of the extended shutdown it will take time to ramp up production to the levels needed. She said the FDA will continue to allow nutritional imports as long as necessary.

[Associated Press; By MATTHEW PERRONE and LINDA A. JOHNSON]

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