Pulmicort Linked To Increased Risk Of Death Among Infants: Study

European researchers warn that the long-term side effects of Pulmicort, which is used to prevent bronchopulmonary dysplasia among extremely preterm infants, may actually increase their risk of death. 

The study was published last week in the New England Journal of Medicine, seeking to determine how inhaled glucocortocoids affected the neurodevelopment of preterm infants.

According to the findings, inhaled budesonide-based glucocorticoids like Pulmicort did not appear to affect the rate of neurodevelopmental disability among infants. However, infants treated with the medication appeared to have higher rates of mortality.

The study involved 863 infants who were born between 23 weeks and 28 weeks, considered extremely preterm. About half were given inhaled budesonide and half were given a placebo within 24 hours after birth. Researchers were initially looking for the development of cerebral palsy, cognitive delays, deafness or blindness developing among the infants in the study.

The treatments are given as a mean to prevent bronchopulmonary dysplasia (BPD), which is a form of chronic lung disease which mostly affects premature infants. In most cases, infants recover from BPD on their own, but in some cases it can cause inflammation and scarring of the lungs, resulting in long-term breathing problems. In most cases, the illness is caused by mechanical ventilation and long-term oxygen use.

According to the findings, there was no statistically significant difference in neurodevelopmental disability among the infants given Pulmicort or a placebo by the time they reached age 2. However, infants in the budesonide group had a 37% increased risk of death, with 82 of 413 infants given the drug dying, compared to only 58 of 400 infants given a placebo.

“Among surviving extremely preterm infants, the rate of neurodevelopmental disability at 2 years did not differ significantly between infants who received early inhaled budesonide for the prevention of bronchopulmonary dysplasia and those who received placebo, but the mortality rate was higher among those who received budesonide,” the researchers concluded.