Editor’s note: This is the seventh of 12 articles from the Food and Drug Administration (FDA) highlighting some of the 500 products that have received new pediatric labeling information since 1998.
Efficacy has been demonstrated in 17 of 23 (74%) anesthesia, analgesia and addiction products studied in the pediatric population over the past 15 years. Three of the remaining six products had new safety information added to the product labeling; two had clinical trial information added; and one product had only pharmacokinetic information added.
The anesthesia products studied include those used to initiate and maintain sedation in intubated or mechanically ventilated patients, adjunctive therapies for general anesthesia, and products to speed postoperative recovery by reversal of non-depolarizing neuromuscular-blocking agents. Studies also have been conducted for analgesics, nonsteroidal anti-inflammatory drugs and smoking cessation treatments.
Safety and efficacy have been shown in patients ages 2 years and older for acetaminophen (Ofirmev), and...