PROPULSID: A Heartburn Drug, Now Linked to Children's Deaths
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. subsid...
Source: latimes.com