E-DRUG: Warning Label For Cisapride Strengthened

[srahmad@essential.org]

E-DRUG: U.S. FDA Strengthens Warning Label For Cisapride
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T98-39                          
June 29, 1998                   
                                
        FDA STRENGTHENS WARNING LABEL FOR PROPULSID

FDA is advising doctors about new warnings of cardiac problems 
associated with the drug Propulsid (cisapride), a treatment for 
nighttime heartburn. FDA's warning is being issued in conjunction with 
a "Dear Healthcare Professionals letter" from the drug's sponsor, 
Janssen Pharmaceutica of Titusville, NJ. The drug's labeling has been 
revised to include new information about the cardiac risks associated 
with the drug and to recommend that other therapies for heartburn 
generally be used before Propulsid.

These actions were prompted by reports of serious adverse reactions -- 
including heart rhythm disorders and deaths associated mostly with the 
use of the drug in people who were taking certain other medications or 
who had particular underlying medical conditions. From 1993 to 1998 
there were 38 reports of deaths in the U.S. Nevertheless, FDA cannot
directly link reported deaths to the drug.

The "Dear Healthcare Professionals letter" and revised labeling for 
Propulsid emphasize that the drug should not be used in patients taking 
certain antibiotics, antidepressants, antifungals, protease inhibitors, 
or various other drugs. The strengthened warnings also contraindicate 
the drug's use in patients with certain disorders--such as congestive 
heart failure, multiple organ failure, chronic obstructive pulmonary 
disease which causes serious respiratory problems, and advanced cancer. 
Propulsid should also not be administered to patients with electrolyte 
disorders (hypokalemia or hypomagnesemia). These include patients with 
severe dehydration, vomiting, diarrhea, or malnutrition, or those 
taking potassium-wasting diuretics and/or insulin in acute settings, or 
who might experience rapid reduction of plasma potassium.

Furthermore, because of the risks associated with the drug and the many 
factors that need to be considered when properly administering it, 
doctors are being advised that Propulsid should usually be used in 
patients who have not responded adequately to lifestyle modifications 
or other drugs for treating nighttime heartburn due to gastroesophageal 
reflux disease.

Propulsid's current labeling states that the drug's use should be 
discontinued if relief from nighttime heartburn does not occur.
The labeling further specifies that the minimum effective dose should 
be used and recommended doses should not be exceeded. It is also 
recommended that the daily dose be halved in patients with reduced liver 
function.

Propulsid was approved by the FDA in tablet form in 1993, and in 
suspension form in 1995 after 23 months of review. Health care providers 
should report any adverse events related to Propulsid to Janssen 
Pharmaceutica (800-526-7736) or to FDA. Reports may be submitted to FDA 
by telephone (800-332-1088), by fax (800-332-0178), or by mail using a 
postage paid MedWatch form from the back of the Physicians Desk 
Reference. The MedWatch report should be mailed to:

MedWatch (HF-2)
Food and Drug Administration
5600 Fishers Lane
Rockville, MD 20857, USA

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