MERCK's INDOCIN I.V. FOR PATENT DUCTUS ARTERIOSUS (PDA)

MERCK's INDOCIN I.V. FOR PATENT DUCTUS ARTERIOSUS (PDA) could be used as an alternative to surgery in as many as 16,000 to 17,000 newborns per year, according to a recent company press release. "More than 70,000 premature infants born in this country each year are at high risk of PDA. Until now surgery has been necessary to correct this condition in 16,000 to 17,000 of those cases." Indocin I.V., the package insert states, "is indicated to close a hemodynamically significant patent ductus arteriosus in premature infants weighing between 500 and 1,750 g when after 48 hours usual medical management (e.g., fluid restriction, diuretics, digitalis, respiratory support, etc.) is ineffective." The insert continues, "Clear-cut clinical evidence of a hemodynamically significant patent ductus arteriosus should be present, such as respiratory distress, a continuous murmur, a hyperactive precordium, cardiomegaly and pulmonary plethora on chest x-ray." The release notes that while surgery to correct PDA can be performed rapidly and with a high degree of success, "the surgery is delicate and entails a degree of risk." Further, "the surgery is largely restricted to major pediatric medical centers staffed with pediatric surgical teams. In addition, the physical trauma to the infant and the emotional trauma to parents and family can be significant," Merck pointed out. In an FDA press release, Com. Young, praised the company for developing the new use as a "public service." Young noted that "Indocin I.V. has little profit potential, but will mean a great deal for the premature infants born with this condition." The drug was recommended for approval for use in premature infants with PDA by FDA's Cardio-Renal Advisory Cmte. on Nov. 4, 1983.