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Is Propulsid Safe for Babies?

February 7, 2000

WASHINGTON (AP) _ Frightened parents began calling pediatricians when they saw newspaper reports warning: Get an EKG before using the heartburn drug Propulsid because it might stop your heart.

That warning was aimed at adults, because Propulsid is approved only for adult use.

But many children, mostly infants and premature babies, take this drug anyway _ and some have died or suffered irregular heartbeats. So do babies need their hearts tested before taking Propulsid, too? And when is this illness bad enough that infants need medication at all?

The Food and Drug Administration is mum on those questions. Pediatric experts say Propulsid’s side effect appears very rare, but that it should be a last resort used carefully in babies.

And specialists say the Propulsid controversy illustrates a major problem: Sick children repeatedly take adult drugs when no one knows if they really work or are safe for youngsters because there is no choice. Too few drug companies study how their products affect children.

``It’s expensive to do drug trials. If they can use it for adult indications, they can make their money on that,″ explained Dr. Robert D. Baker, who is writing guidelines on how to treat babies with heartburn-causing ``gastroesophageal reflux.″

Propulsid is widely used in infants _ in one survey of 58,000 premature babies’ medical records, 20 percent took it, said Dr. James Lemons, Indiana University Medical Center’s neonatology chief, who is advising FDA on the issue.

Now, ``there’s going to be a dramatic reduction″ in use until studies settle the questions, he said. ``People will obtain EKGs prior to putting babies on (Propulsid) and will need to follow them closely.″

When and how to treat these babies is complicated.

Reflux occurs when stomach acid backs up in the esophagus. Adults call that burning feeling heartburn. Babies react by spitting up.

All babies do that. It’s normal considering the esophagus and stomach are immature at birth, particularly in preemies.

Some 95 percent of babies will outgrow the problem by their first birthday, Baker said. ``So you try not to treat it.″

But when reflux is bad enough that babies become malnourished and don’t gain weight, have trouble breathing while vomiting, or the esophageal irritation causes obvious pain, Baker says it’s time to treat.

Step 1: Giving frequent small meals instead of fewer large ones, burping babies well, keeping them upright for half an hour after meals, and elevating the head of the crib can help, Baker advises. Sometimes thickening formula with rice cereal helps, too.

If that doesn’t help, he tries special doses of prescription antacids like Zantac or Prilosec.

When those fail, Baker prescribes Propulsid, which is not an antacid but instead helps push food through the stomach.

In babies, ``the evidence it works is not very strong,″ Baker cautions. ``You wouldn’t say it was a miracle drug. It’s a little bit of an aid.″

How safe is it? Of the 70 deaths known by the FDA among Propulsid users since 1993, 11 were among children. The FDA knows of another 20 children who suffered nonfatal heart rhythm disturbances.

Experts say some were babies clearly given too high a dose. They say it’s critical that babies pass an EKG before taking Propulsid, take a cautious dose and don’t take other medicines that combine dangerously with Propulsid.

Baker’s belief: ``When used in the right way, it’s a safe drug.″

The FDA, however, says it lacks data to offer parents or pediatricians advice. ``The adult warning describes what’s happening in adults. In kids ... we don’t really know what to warn about,″ said FDA’s Dr. Florence Houn.

Manufacturer Janssen Pharmaceutica notes that some European countries sell Propulsid as a second-choice treatment for some babies _ although Canada forbids its use in premature babies. At FDA’s urging, Janssen began a small study of infant doses, saying it only recently realized many infants took the drug.

But one mother whose 6-month-old died in 1998 while taking Propulsid says parents must know there’s a danger.

``People don’t realize,″ say Karen Brown of East Moline, Ill., whose son Chase was put straight on Propulsid without trying antacids or getting an EKG first. ``I didn’t know it ’til I lost a child.″

___

EDITOR’S NOTE _ Lauran Neergaard covers health and medical issues for The Associated Press in Washington.

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