Propulsid Warning

[John Stafford <johnws@xxxxxxxxxxxxx>]

FDA Issues Heartburn Drug Warning

June 30, 1998

WASHINGTON - The Associated Press via
NewsEdge Corporation : The government
urged doctors Monday to prescribe heartburn
patients every reasonable alternative before
trying the drug Propulsid, issuing new
warnings that it may cause serious heart
problems.

The Food and Drug Administration
strengthened warnings on Propulsid's label
after reports of hearth rhythm abnormalities,
including 38 deaths, since the pill hit the
market in 1993.

The FDA noted that it cannot prove the drug
caused any deaths, but said Propulsid _
approved specifically for nighttime heartburn
_ already was known to cause heart
arrhythmias when taken together with certain
other medicines. Monday's action strengthens
those warnings, adding newly discovered
drug interactions and a list of other illnesses
that increase the risk.

Manufacturer Janssen Pharmaceutica wrote
thousands of doctors and pharmacists
Monday to alert them to the strengthened
warnings.

The warnings say:

_Never prescribe Propulsid, known chemically
as cisapride, to patients taking a list of other
drugs, including such antibiotics as
erythromycin, antifungals such as
ketoconazole, certain antidepressants or any
AIDS drugs known as protease inhibitors.

_Never prescribe Propulsid to patients with
congestive heart failure, chronic obstructive
pulmonary disease, advanced cancer or
electrolyte disorders, including dehydration
and vomiting. Also do not give it to patients
needing acute-care diuretic or insulin
treatment.

There are some people who still could benefit
from Propulsid, said FDA drug chief Dr. Murray
Lumpkin. But ``this really ought to be the
drug for after you've tried everything else,''
he stressed.

John Stafford --  --
johnws@xxxxxxxxxxxxx
................... Si fallatis officium, quaestor infinitius eat se
quicquam scire de factis vestris.