FDA Adds Heat-Risk Warning to Transderm Scōp (Scopolamine Patch): What Patients, Clinicians, and Manufacturers Need to Know

What happened (and when)?

On June 18, 2025, the U.S. FDA issued a Drug Safety Communication requiring new warnings for the anti-nausea patch Transderm Scōp. The agency concluded the patch can increase body temperature and lead to heat-related complications, with reports that include hospitalizations and, in some cases, death. Most reported cases occurred in children ≤17 years and adults ≥60 years, age groups that are more vulnerable to problems with body-temperature regulation. U.S. Food and Drug Administration+2U.S. Food and Drug Administration+2

What is Transderm Scōp and why is it used?

Transderm Scōp is a transdermal anticholinergic (scopolamine) patch worn behind the ear to prevent nausea/vomiting from motion sickness or post-operative recovery. Each patch delivers 1 mg over 3 days. FDA Access Data Kaiser Permanente

Key pharmacology: scopolamine blocks muscarinic receptors (anticholinergic), which can reduce nausea signals—but anticholinergic effects can also impair sweating and thermoregulation, raising the risk of hyperthermia (dangerously elevated body temperature) during heat exposure. This mechanistic risk aligns with the FDA’s new warning. U.S. Food and Drug Administration

What exactly is the new safety concern?

Risk: Hyperthermia and heat-related illness (e.g., heat exhaustion, heat stroke) while wearing the patch—especially in hot environments or with other heat-predisposing factors. U.S. Food and Drug Administration+1
Who’s most at risk:
- Children and teens (≤17 years)
- Older adults (≥60 years)
- Anyone with impaired heat dissipation (dehydration, febrile illness), on other anticholinergic or sedating drugs, or exposed to high ambient temperatures (outdoors, saunas, hot tubs, poorly ventilated rooms). U.S. Food and Drug Administration
Clinical outcomes reported: hospitalizations and rare deaths from heat-related complications. U.S. Food and Drug Administration

What does current labeling already say?

The FDA-approved label (updated 2025) includes longstanding warnings (e.g., acute angle-closure glaucoma risk due to mydriasis) and product use instructions. The heat-risk addition is a newly emphasized safety concern prompted by recent case reviews; manufacturers must reflect this in prescribing information and Medication Guide. FDA Access Data U.S. Food and Drug Administration

How to recognize heat-related illness (fast checklist)

Early signs: fatigue, headache, dizziness, flushed/dry skin, excessive thirst, decreased sweating, nausea.
Progressing signs (emergency): confusion, agitation, fainting, vomiting, very high body temp, rapid pulse, seizures. Remove the patch and seek urgent medical care if severe symptoms occur. (General clinical criteria for heat illness contextualize FDA’s warning.) U.S. Food and Drug Administration

Practical guidance by audience

For patients & caregivers

Before use: Tell your clinician about eye disease (glaucoma), heart/kidney problems, other medicines (especially anticholinergics, some antihistamines, tricyclics), and any history of heat intolerance. FDA Access Data
While wearing the patch:
- Avoid overheating: limit time in hot weather, saunas, hot tubs; ensure AC/ventilation; hydrate.
- Monitor for heat symptoms (see checklist above).
- Keep patch dry and intact; if it falls off, follow label on replacement timing.
- For children and older adults, use extra caution and supervision. U.S. Food and Drug Administration
If symptoms occur: Remove the patch immediately and seek medical help; report the event to FDA MedWatch. U.S. Food and Drug Administration

For clinicians (prescribers, pharmacists, peri-op teams)

Risk stratify: counsel all patients on heat-risk; flag high-risk groups (pediatrics, geriatrics, those on multiple anticholinergics/sedatives). U.S. Food and Drug Administration
Medication review: minimize concomitant anticholinergic burden where feasible during patch use (e.g., certain antihistamines, bladder antimuscarinics). U.S. Food and Drug Administration
Peri-operative use: ensure postoperative environments avoid overheating; provide clear discharge instructions on heat precautions. U.S. Food and Drug Administration
Ophthalmic caution: recognize/educate on acute angle-closure glaucoma symptoms (sudden eye pain, halos, headache, nausea); urgent ophthalmology if suspected. FDA Access Data PMC
Reporting: promptly submit adverse events to MedWatch to aid ongoing safety surveillance. U.S. Food and Drug Administration

For hospitals & health systems

Update EHR order sets, patient instructions, and discharge templates with heat-risk language; add clinical decision support alerts for high-risk ages and interacting meds.
Ensure peri-op and ward protocols include ambient temperature control guidance for patients with scopolamine patches. U.S. Food and Drug Administration

What manufacturers must do

Revise Prescribing Information (PI) and Medication Guide to add FDA-specified heat-risk warnings and counseling points.
Risk communication: distribute Dear HCP/Pharmacist letters, update websites and packaging inserts, and brief medical information teams.
Pharmacovigilance: enhance case finding for heat illness (MedDRA terms like “hyperthermia,” “heat stroke”), perform targeted signal detection, and submit periodic updates to FDA.
Human factors & labeling review: ensure warnings are conspicuous and consumer-comprehensible; consider iconography for heat/temperature.
Training & audits: refresh MLR review checklists, pharmacy helpline scripts, and field-medical FAQs to align with the Drug Safety Communication. U.S. Food and Drug Administration

FDA’s Drug Safety Communications page lists this action under “06-18-2025: Transderm Scōp heat-related complications”, which sponsors should track alongside other 2025 class communications. U.S. Food and Drug Administration

Key contraindications and existing warnings to remember

Contraindicated in angle-closure glaucoma and in patients hypersensitive to scopolamine/belladonna alkaloids.
May precipitate acute angle-closure due to mydriasis; educate patients on ocular red flags.
CNS effects (confusion, drowsiness), dry mouth, urinary retention—caution in the elderly. FDA Access Data RxList

Quick reference: actions at a glance

Stakeholder	Do this now
Patients/Caregivers	Use patch as directed; avoid heat exposure; hydrate; watch for symptoms; remove patch & seek care if heat illness suspected; report to MedWatch. U.S. Food and Drug Administration
Clinicians/Pharmacists	Counsel on heat risk; review anticholinergic co-meds; plan peri-op environments; recognize angle-closure signs; report AEs. U.S. Food and Drug Administration FDA Access Data
Hospitals/Clinics	Update EHR and discharge materials; add CDS alerts; educate staff. U.S. Food and Drug Administration
Manufacturers	Update PI/Med Guide; execute communication & PV plans; strengthen labeling prominence and HCP education. U.S. Food and Drug Administration

Sources & further reading

FDA Drug Safety Communication (consumer/HCP versions): heat-related complications with Transderm Scōp (posted June 18, 2025). U.S. Food and Drug Administration+1
FDA Drug Safety Communications index (confirms date and action). U.S. Food and Drug Administration
Approved U.S. label (2025): contraindications and ocular warnings. FDA Access Data
Independent summaries: MedlinePlus safety note; The Medical Letter brief on hyperthermia cases. MedlinePlus The Medical Letter

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