Two Popular Prenatal Steroids in Short Supply.

Some forced to use hydrocortisone instead.

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