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July 14, 2025
On June 18, 2025, the Food and Drug Administration (FDA) issued a safety warning about the serious risk of heat-related complications for individuals using the scopolamine transdermal system (TRANSDERM SCŌP), a patch used to treat nausea and vomiting.[1] The patch can increase body temperature and decrease sweating, leading to heat-related complications such as confusion, loss of consciousness, hospitalization, or, in some cases, even death.
The FDA advised that anyone — especially children younger than 17 and adults older than 60 — should remove the patch immediately if they experience symptoms of hyperthermia, including elevated body temperature or reduced sweating. Avoid using external heat sources, such as heated blankets, and stay away from warm environments.
Initially approved in 1979, the scopolamine transdermal system is a patch used in adults to treat nausea and vomiting associated with motion sickness and recovery from anesthesia.[2] The antinausea patch works by releasing scopolamine, an anticholinergic agent that blocks signals in the brain responsible for nausea and vomiting. The patch is applied behind the ear and delivers 1 milligram of scopolamine, which begins to have an antiemetic effect within four hours and lasts up to three days.
The patch should not be used by individuals with angle-closure glaucoma or hypersensitivity to scopolamine. Although not approved for use in children, the scopolamine transdermal system has occasionally been prescribed off-label to treat excessive drooling in children with cerebral palsy or other neurological disorders.[3]
The updated safety warning adds the risk of hyperthermia to the prescribing information and patient information leaflet for transdermal scopolamine. Anticholinergic agents like scopolamine can elevate core body temperature and decrease sweating, and these effects may be worsened by exposure to external heat sources or high-temperature environments. If unrecognized or unmanaged, these symptoms can lead to the serious complications associated with the patch. Most cases of hyperthermia occur within 72 hours of application. Even after patch removal, withdrawal symptoms such as dizziness, headache and nausea may persist for several days as the absorbed medicine remains in the body.[4]
The FDA’s warning is based on 13 global cases of hyperthermia reported in patients using the antinausea patch, including seven in the United States. Of these cases, eight involved children younger than 17 and four involved adults older than 60. Four cases resulted in hospitalization, and two resulted in death — one involving a child and one an older adult. The FDA “determined there is reasonable evidence of a causal association between the scopolamine patches and hyperthermia based on how the medicine works, including its ability to cross the blood-brain barrier, a membrane that prevents potentially harmful substances in the blood from reaching the brain.”[4]
If you use the scopolamine transdermal system, Public Citizen’s Health Research Group recommends that you monitor for any signs of excessive heat or temperature disturbance, remove the patch immediately if symptoms occur, and contact your clinician.
To see the FDA’s alert, visit the following link: https://www.fda.gov/media/187121/download?attachment.
Report any adverse events associated with transdermal scopolamine (TRANSDERM SCŌP) to the FDA’s MedWatch program by calling 1-888-463-6332 or going to https://www.accessdata.fda.gov/scripts/medwatch/.
References
[1] U.S. Food and Drug Administration. FDA adds warning about serious risk of heat‑related complications with antinausea patch (Transderm Scōp [scopolamine transdermal system]). June 18, 2025. https://www.fda.gov/media/187121/download. Accessed July 10, 2025.
[2] . U.S. Food and Drug Administration. Scopolamine New Drug Application 017874/S-018 & S-027: Transderm Scōp (scopolamine transdermal system). 2001. https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/017874_S018%20&%20S027_SCOPOLAMINE_AP.pdf. Accessed July 10, 2025.
[3] U.S. Food and Drug Administration. TRANSDERM SCŌP (scopolamine transdermal system) prescribing information. April 2025. https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/017874s053lbl.pdf. Accessed July 10, 2025.
[4] U.S. Food and Drug Administration. FDA adds warning about serious risk of heat‑related complications with antinausea patch (Transderm Scōp [scopolamine transdermal system]). June 18, 2025. https://www.fda.gov/media/187121/download. Accessed July 10, 2025.
