FDA warns of hyperthermia risk with scopolamine transdermal system after pediatric and off‑label cases

Leah Herity described DPV’s review of a safety signal tying scopolamine transdermal system to hyperthermia, particularly when used off‑label or in pediatric patients.

Herity said the signal originated in a foreign regulator’s drug safety update that described serious anticholinergic effects, including a child death linked to hyperthermia. Because the patch is approved in the U.S. only for adults to prevent motion‑sickness and postoperative nausea and vomiting, DPV examined foreign cases, FAERS reports, literature, and drug utilization data. "We identified 13 cases of hyperthermia with scopolamine transdermal system," she said, noting a mix of U.S. and foreign reports and that the majority of cases involved off‑label use, including long‑term application, pediatric patients and use for secretion control.

Biological plausibility supported the review: scopolamine is an anticholinergic agent and anticholinergic syndrome can manifest as hyperthermia and reduced sweating. DPV found four cases requiring hospitalization and two deaths; some cases involved improper use such as cutting patches or applying multiple patches. A multidisciplinary review concluded regulatory action was needed.

As a result, labeling was updated to include a new warning for hyperthermia and population‑specific language describing pediatric risks; FDA also released a drug safety communication summarizing the cases, body temperatures reported, risk factors and mitigation advice for prescribers and patients.

The presenters emphasized that many of these events involved off‑label use and that prescribers should be aware of pediatric and long‑term use risks described in the updated labeling.