Submit RFI/RFP
Request Consultation
Scopolamine transdermal patches were approved by the FDA in the 1970s for managing nausea and vomiting caused by motion sickness; later, they also got FDA approval for recovery from anesthesia or opioid pain medicines used during surgery.
Scopolamine is an anticholinergic medication that works by blocking nerve signals in the brain responsible for triggering nausea and vomiting. It is placed behind the ear and provides continuous drug release for up to three days.
Even though it is not FDA for use in children, there are cases where it has been prescribed off-label for children in order to manage excessive drooling in children with cerebral palsy or other neurologic disorders.
Which in turn has led to serious side effects in some patients. On the 16th of August 2024, the FDA received 13 reports of hyperthermia linked to scopolamine patches, including 7 in the U.S. Most cases occurred within 72 hours of use, primarily affecting children and older adults groups more vulnerable to heat-related complications. Four cases led to hospitalization, and two resulted in death. The FDA found a likely causal link due to scopolamine’s anticholinergic effects and its ability to cross the blood-brain barrier.
That is why it is very crucial for healthcare professionals to keep their patients informed about possible risk of adverse events & how to act upon sudden hyperthermia. Moreover, children younger than 17 years & patients over 60 years old should be very careful upon using these patches as they maybe more susceptible to the anticholinergic effects of thermoregulatory disruption.
To address the risk of serious harm from hyperthermia, the FDA has required updates to the Transderm scop prescribing information and patient leaflet. These changes include clear guidance to help minimize risk especially for children and older adults such as removing the patch if body temperature rises or sweating decreases in warm environments, and seeking prompt medical attention if symptoms occur.
Submit RFI/RFP