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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.