HEARTBURN DRUG LINKED TO 70 DEATHS, FDA SAYS

WASHINGTON -- The popular prescription nighttime heartburn drug
Propulsid has been linked to 70 deaths and more than 270 significant
negative reactions since 1993, the Food and Drug Administration warned
Monday.

The agency took the additional step of recommending that doctors test
all patients before prescribing the drug to make sure they don't
suffer from a heart condition or other ailments that would make taking
the drug dangerous. It also said the drug, which can cause
life-threatening irregular heartbeats, should only be used as a last
resort.

``This is a serious problem, but in our view a rare problem,'' said
Florence Houn, the FDA's chief for gastrointestinal drugs.
``Doctors and patients need to understand and learn more about the
risks and benefits of the drug.''

The action by the FDA represents the latest attempt to warn doctors
and the public about the possible dangers of Propulsid. The FDA has
already strengthened Propulsid's label several times in recent years,
with increasingly strong warnings to patients with certain heart
rhythm disorders and those taking a wide range of other medications.
When the agency significantly broadened the warning language in 1998,
38 deaths had already been associated with the drug.

But according to the FDA, 85 percent of the 270 adverse reactions
occurred in patients with risk factors already outlined on Propulsid's
label, people who were in clear danger of an adverse reaction to the
drug.

A spokesman for Janssen Pharmaceutica of Titusville, N.J., an arm of
Johnson & Johnson, said that while the new warning was warranted, the
drug remained safe if used properly. The company Monday sent a letter
to doctors summarizing the new warnings and precautions on the drug's
label.

About 6 million Propulsid prescriptions were sold last year and 30
million since the drug was approved, said Janssen spokesman Greg
Panico. Propulsid was the 72nd leading prescription drug in 1998,
according to a survey by Scott-Levin Associates reported in the
publication American Druggist.

``The fact that there have been only 270 adverse events after 30
million prescriptions points to the relatively rarity of the
problem,'' Panico said.

Some consumer advocates have criticized the FDA in recent years for
approving drugs before they have been thoroughly studied, and for
approving drugs with known risks and failing to monitor them carefully
enough once they are on the market.

Sidney M. Wolfe of the Health Research Group at Public Citizen, a
frequent critic of FDA policies, said that Propulsid was a good
example of what the consumer organization believes is going wrong at
the agency.

``Most of the use of this drug is inexcusable,'' he said. ``It was
heavily promoted for acid reflux in the stomach when it came out, and
that's when doctors got their impression about whether or not to use
it. The FDA has made a series of warnings since then, but our studies
show that doesn't really change prescribing patterns.''

He said that Propulsid, or cisapride, should be taken off the market
except for several specific research uses.

The FDA's Houn said the drug should not be pulled because it helps
some patients who are not helped by other drugs.

In an effort to increase awareness of the drug's potential dangers,
the FDA will hold a public advisory committee meeting April 12 to
discuss its findings.