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[IP] Gastropareisis: any of us who have this 'wonderful' complication please read:


Propulsid - Urgent FDA Warning
Cisapride (Propulsid) is a drug that is commonly used in the treatment of 
heartburn in patients with gastroesophageal reflux disease (GERD). It has been 
on the market in the U.S. since 1993. It has now been found to be the cause of 
dangerous heart irregularities. All patients taking the drug should contact 
their doctors immediately. The following warning by the Food and Drug 
Administration (FDA) explains why. 
-- Editor, MedicineNet.com

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 
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).

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