NEW YORK, Jan 24 (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.
