The American Academy of Pediatrics (AAP) has issued a clinical report highlighting serious adverse events related to off-label use of OTC oxymetazoline nasal spray in children before and after surgery, noting that in these situations the drug “may be dosed without attention to the volume administered.” The report cites recent cases of young children who suffered serious cardiovascular issues after receiving oxymetazoline during procedures. The report also points out that similar serious adverse events due to accidental ingestion of oxymetazoline by children led to an FDA warning in 2012.
Oxymetazoline nasal sprays are approved in the US for the treatment of sinus congestion in patients aged 6 and older. According to the report, oxymetazoline nasal spray “is used off label in the operating room to prepare the nasal passages during nasal intubation and during ear, nose, and throat (ENT) surgery to improve visualization of the airway and to minimize intraoperative or postoperative bleeding,” including in children younger than 6 years old.
Among other recommendations, the report urges health care professionals, especially anesthesiologists, to ensure that the spray pump is oriented correctly in an upright position in order to minimize the risk of delivering excessive amounts of the drug. The child should also be upright if possible, the AAP says.
In an AAP news release, report co-author Joseph D. Tobias emphasized, “People just really need to be careful that when you turn that bottle upside down, it no longer delivers the volume you think you’re supposed to get.” According to the AAP, an inverted bottle may deliver a dose of as much as 1.5 mL per spray compared to 0.03 mL delivered when the bottle is upright.
Clinicians should also have a method for tracking the amount of drug administered, the AAP said. The report urges the establishment of dosing guidelines for infants and children but acknowledges the lack of pediatric PK data that would be necessary for establishment of such guidelines. To remedy that problem, the organization is calling for pediatric PK trials for both surgical and nonsurgical use of oxymetazoline nasal sprays.
Read the AAP clinical report.
Read the AAP press release.
