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Times Staff Writer
In mid-1993, FDA officials prepared to approve Propulsid, a drug that eased nighttime heartburn. But a sign of danger loomed.
FDA medical officer Andre Dubois noted that 48 of 1,993, or 2.4%, of the patients who took Propulsid in U.S. studies experienced “heart rate and rhythm disorders.” In addition, eight children age 6 or younger who were given Propulsid had died.
Dubois found that the drug’s chemical makeup could disturb cardiac function. But he agreed with drug maker Janssen Pharmaceutica, a Johnson & Johnson Co. subsidiary, that the deaths in the studies were attributable to other causes.
He recommended approval along with disclosure in the label of potential cardiac effects. “The risk seems very low,” he said. ....

United States , United Kingdom , Andre Dubois , Florence Houn , Raymondj Lipicky , Janet Woodcock , Stephenb Fredd , Robertr Fenichel , Janssen Pharmaceutica , Tina Englebrick , Greg Panico , Lilia Talarico , American Society For Pediatric Gastroenterology , University Of Pittsburgh , British Medicines Control Agency , Johnson Co , American Journal , Gage Stevens , North American Society , Pediatric Gastroenterology , ஒன்றுபட்டது மாநிலங்களில் , ஒன்றுபட்டது கிஂக்டம் , ஆண்ட்ரே டுபோயிஸ் , ஜேனட் மரக்கட்டை , அமெரிக்கன் சமூகம் க்கு குழந்தை இரைப்பை குடல் , பல்கலைக்கழகம் ஆஃப் பிட்ஸ்பர்க் ,