The FDA is warning that the antinausea patch Transderm Scōp (scopolamine transdermal system) can increase body temperature and cause heat-related complications, resulting in hospitalization or even death in some cases. Most cases occurred in children 17 years and younger and in adults 60 years and older, who may be sensitive to body temperature control disturbances. Transderm Scōp is not approved for use in children.
For this reason, the FDA has required the addition of a new warning and other information about the risk of hyperthermia resulting in serious harm. The warning, which is now included in the Transderm Scōp patch prescribing information and patient information leaflet, notes that the risk may be exacerbated by exposure to external heat sources (e.g., heated blankets) or high environmental temperatures. The updated prescribing information instructs patients to remove the patch from the skin and contact their health care professional if their body temperature increases or they are not sweating in warm environmental temperatures.
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