Survanta Adverse Reactions

The most commonly reported adverse experiences were associated with the dosing procedure. In the multiple-dose controlled clinical trials, transient bradycardia occurred with 11.9% of doses. Oxygen desaturation occurred with 9.8% of doses.
Other reactions during the dosing procedure occurred with fewer than 1% of doses and included endotracheal tube reflux, pallor, vasoconstriction, hypotension, endotracheal tube blockage, hypertension, hypocarbia, hypercarbia, and apnea. No deaths occurred during the dosing procedure, and all reactions resolved with symptomatic treatment.
The occurrence of concurrent illnesses common in premature infants was evaluated in the controlled trials. The rates in all controlled studies are in Table 4.

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When all controlled studies were pooled, there was no difference in intracranial hemorrhage. However, in one of the single-dose rescue studies and one of the multiple-dose prevention studies, the rate of intracranial hemorrhage was significantly higher in SURVANTA patients than control patients (63.3% v 30.8%, P=0.001; and 48.8% v 34.2%, P=0.047, respectively). The rate in a Treatment IND involving approximately 4400 infants was lower than in the controlled trials.
In the controlled clinical trials, there was no effect of SURVANTA on results of common laboratory tests: white blood cell count and serum sodium, potassium, bilirubin, creatinine.
More than 3700 pretreatment and post-treatment serum samples were tested by Western Blot immunoassay for antibodies to surfactant-associated proteins SP-B and SP-C. No IgG or IgM antibodies were detected.
Several other complications are known to occur in premature infants. The following conditions were reported in the controlled clinical studies. The rates of the complications were not different in treated and control infants, and none of the complications were attributed to SURVANTA.
Respiratory: lung consolidation, blood from the endotracheal tube, deterioration after weaning, respiratory decompensation, subglottic stenosis, paralyzed diaphragm, respiratory failure.
Cardiovascular: hypotension, hypertension, tachycardia, ventricular tachycardia, aortic thrombosis, cardiac failure, cardio-respiratory arrest, increased apical pulse, persistent fetal circulation, air embolism, total anomalous pulmonary venous return.
Gastrointestinal: abdominal distention, hemorrhage, intestinal perforations, volvulus, bowel infarct, feeding intolerance, hepatic failure, stress ulcer.
Renal: renal failure, hematuria.
Hematologic: coagulopathy, thrombocytopenia, disseminated intravascular coagulation.
Central Nervous System: seizures.
Endocrine/Metabolic: adrenal hemorrhage, inappropriate ADH secretion, hyperphosphatemia.
Musculoskeletal: inguinal hernia.
Systemic: fever, deterioration.
Follow-Up Evaluations: To date, no long-term complications or sequelae of SURVANTA therapy have been found.
Single-Dose Studies: Six-month adjusted-age follow-up evaluations of 232 infants (115 treated) demonstrated no clinically important differences between treatment groups in pulmonary and neurologic sequelae, incidence or severity of retinopathy of prematurity, rehospitalizations, growth, or allergic manifestations.
Multiple-Dose Studies: Six-month adjusted age follow-up evaluations have not been completed. Preliminarily, in 605 (333 treated) of 916 surviving infants, there are trends for decreased cerebral palsy and need for supplemental oxygen in SURVANTA infants. Wheezing at the time of examination tended to be more frequent among SURVANTA infants, although there was no difference in bronchodilator therapy.
Twelve-month follow-up data from the multiple-dose studies have been completed in 328 (171 treated) of 909 surviving infants. To date no significant differences between treatments have been found, although there is a trend toward less wheezing in SURVANTA infants in contrast to the six month results.