Two Popular Prenatal Steroids in Short Supply.
CHICAGO -- A shortage of two steroids widely used in women at risk for premature delivery has forced some providers to rely on other steroidal alternatives as they wait for the supply to be replenished.
Dexamethasone and betamethasone, two steroids that have been shown to vastly improve neonatal outcomes by accelerating fetal lung development, are in such short supply that, "in my institution we've had to go to hydrocortisone 500 mg every 12 hours," Dr. James Martin said at the annual meeting of the American College of Obstetricians and Gynecologists.
"What's worrying is that [dexamethasone and betamethasone] have long and proven track records of being good for fetal lung maturation purposes, and we have less experience with hydrocortisone," Dr. Martin, professor and chief of maternal-fetal medicine at the University of Mississippi Medical Center, Jackson, said in an interview.
American Regent Laboratories, Shirley, N.Y., a major manufacturer of the generic brand of dexamethasone sodium phosphate, blames their raw material supplier of dexamethasone for the shortage. The supplier, which is based in France, switched from producing an oxen-based-to a plant-based material several months ago in response to a freeze placed on the production of all bovine products by the French government.
American Regent began manufacturing the injectable form of dexamethasone with the new plant material, but within months the Food and Drug Ad ministration ordered the company to submit data on 3-month stability testing to ensure that the potency of the drug remained stable over time.
At press time, American Regent had just received the green light from the FDA to market its plant-based drug, but it's still going to be until well into July--maybe even later--before supply is able to keep up with demand, said Mary Jane Helenek, the company's senior vice president. Nearly 200,000 units of the drug were expected to be shipped to whole sale distributors during the week of May 7. But that doesn't even come close to covering the 2 million units that are on back order, she added. Another few batches are expected to be shipped shortly thereafter. But that's pending availability of the raw material, which is also in short supply
"We will be sending out a 'Dear Healthcare Provider' letter asking them to use the drug only for patients who need it most critically," Ms. Helenek said.
American Regent's inventory of animal-based dexamethasone has been entirely depleted.
Meanwhile, back orders are also piling up for Merck and Co.'s brand name formulation of dexamethasone, Decadron. Although less forthcoming about the reason for the short supply, a customer service representative at Merck cited "manufacturing de lay" and no release date in sight.
Making things still worse, re quests for Schering-Plough's brand name formulation of betamethasone, Celestone, a well-studied al ternative to dexamethasone, are also on back order, according to a company spokesperson.
The shortage appears to be dealing the worst blow to tertiary hospitals that use a lot of the drugs, said Erin R. Fox, Pharm.D., a drug information specialist at the University of Utah Hospitals and Clinics, Salt Lake City. Dexamethasone is also used for a host of indications from endocrine and rheumatic disorders to cerebral edema.
Dr. Fox said that because of the concurrent shortage of betamethasone, her hospital is re serving dexamethasone exclusively for use in women at risk of preterm delivery Patients with several other conditions requiring dexamethasone can use methylprednisolone instead.
Requests for dexamethasone went on back order in mid-April, and "we are down to five vials [of betamethasone] and no known replenishment coming from back orders," said Dr. William Brannan, director of women's services at Mission St. Joseph's Health System, Asheville, N.C. "We're sequestering IV dexamethasone so a supply would be available" for antenatal use.
Large distributors of dexamethasone, such as Bergen Brunswig Corp., don't have the drug available. Other distributors such as Clint Pharmaceuticals and C.O. Truxton are making a small supply available on a limited basis, Dr. Fox said.
"We have received increasing numbers of calls over the past 4-6 weeks about a shortage of be tamethasone and also a shortage of dexamethasone," said Dr. Stanley Zinberg, vice-president of practice activities for ACOG.
"The tragedy is that we have worked for so many years to get clinicians to think about the use of these drugs, and now all of a sudden supplies of the drug are not available," Dr. Martin said.
"There's no question this is an essential treatment. It's one of the few interventions in obstetrics that has a very good scientific base," Dr. Zinberg said.