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[e-drug] E-DRUG: U.S. FDA UPDATES WARNINGS FOR HEARTBURN DRUG

E-DRUG: U.S. FDA UPDATES WARNINGS FOR HEARTBURN DRUG CISAPRIDE
--------------------------------------------------------------
January 24, 2000 

The Food and Drug Administration (FDA) is advising health care
professionals and patients of important new information, including
recommendations for performing diagnostic tests, that should be
considered prior to any use of the drug cisapride (Propulsid). Cisapride
is a treatment for severe nighttime heartburn in patients with
gastroesophageal reflux disease (GERD) who do not adequately respond to
other therapies. The new measures are being recommended to help
physicians avoid giving cisapride to patients at known risk of rare--
but serious--cardiac events associated with the drug.
As part of an ongoing risk management effort, FDA is also announcing a
public advisory committee meeting to be held on April 12, where the
safety of the drug and additional methods to reduce the occurrence of
adverse events will be discussed.

Meantime, patients who already take the drug are encouraged to ask their
doctors about having the recommended tests performed and whether they
should pursue other treatment options.

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. A recent
analysis of 270 adverse event reports (including 70 fatalities) revealed
that approximately 85% of these cases occurred in patients with these
identifiable risks.

The new risk management measures are being announced in conjunction with
a "Dear Healthcare Professionals" letter issued today by the drug's
sponsor, Janssen Pharmaceutica of Titusville, NJ, that summarizes the
updates being made to the warnings and precautions sections of the
drug's label. The changes include recommending that physicians perform
an electrocardiogram and certain blood tests prior to prescribing the
drug.

The revised labels also list the contraindicated drugs and underlying
conditions which put patients at increased risk. Cisapride should not be
used by patients taking some of the following types of medications:
anti-allergy, anti-angina, anti-arrhythmics (irregular heart rhythm),
antibiotics, anti-depressants, anti-fungals, anti-nausea,
anti-psychotics and protease inhibitors (anti-HIV infection).

It is also advised that patients with any of the following conditions
not take the drug: 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.

Cisapride was approved by FDA in tablet form in 1993, and in suspension
form in 1995. Unlike drugs that reduce stomach acid, cisapride works by
a prokinetic mechanism that moves the harmful acids through the
digestive tract thus preventing its painful reflux into the esophagus. A
previous warning regarding cardiac risks was issued in June 1998.


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