Heart problems associated with heartburn drug
NEW YORK, Jan 24, 2000 (Reuters Health) -- The Food and Drug
Administration (FDA) issued an updated warning regarding the drug
cisapride (Propulsid), which is used to treat severe nighttime heartburn
in patients with gastroesophageal reflux disease (GERD).
The drug should not be given to patients with heart disease-related
chest pain (angina), or those with heart arrhythmias or other
cardiovascular problems.
``Today's actions are prompted by continuing reports of heart rhythm
disorders and deaths associated mostly with the use of the drug in
people who are either taking certain other medications or who have
certain underlying conditions that are known risk factors,'' according
to the FDA.
An analysis of 270 reports of adverse events associated with the drug,
including 70 fatalities, ``revealed that approximately 85% of these
cases occurred in patients with... identifiable risks,'' FDA said in an
advisory issued Monday.
The drug's sponsor, Janssen Pharmaceutica of Titusville, New Jersey, is
issuing a letter to doctors advising them to give patients an
electrocardiogram and blood tests prior to prescribing cisapride.
Patients who are already taking the drug ``are encouraged to ask their
doctors about having the recommended tests performed and whether they
should pursue other treatment options,'' according to the FDA.
FDA stresses that cisapride is contraindicated for patients with angina
and for those on some antiarrhythmic agents, antiallergy agents,
antibiotics, antifungals, antinausea, antipsychotics, and protease
inhibitors.
Other people who should not take the drug include those with ''history
of irregular heartbeats, abnormal electrocardiogram (ECG or EKG), heart
disease, kidney disease, lung disease, low blood levels of potassium,
calcium or magnesium, eating disorder (such as bulimia or anorexia),
dehydration or persistent vomiting.''
The FDA is calling a public advisory committee meeting April 12 to
discuss the safety and use of cisapride in light of the new reports.
Copyright © 2000 Reuters Limited.
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Judith Richards, London, Ontario, Canada
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