The FDA has issued an urgent alert regarding a recent and significant warning from the U.S. Food and Drug Administration (FDA). The FDA has mandated a new warning be added to the label for the scopolamine transdermal patch, commonly known by its brand name, Transderm Scop, as well as its generic counterparts. The critical concern? A serious and potentially fatal risk of hyperthermia.
Understanding the Threat: What is Hyperthermia?
Many of us are familiar with fever, our body’s response to infection where the internal thermostat is reset higher. Hyperthermia, however, is different and far more dangerous. It’s a condition where your body’s core temperature rises uncontrollably and beyond its ability to cool itself, often exceeding 104°F (40°C), without the “thermostat” being reset. It’s essentially overheating, and it can happen when the body’s natural cooling mechanisms—primarily sweating—are overwhelmed or impaired.
The scopolamine patch, an anticholinergic medication used to prevent nausea and vomiting from motion sickness or surgery, works by blocking certain signals in the brain. However, this very mechanism can interfere with the body’s ability to regulate its temperature, specifically by reducing perspiration. This means that even in moderately warm conditions, or when combined with other factors, the patch can lead to a dangerous buildup of heat within the body.
The consequences of hyperthermia can be severe and rapid. As core body temperature escalates, it can lead to:
- Heat Exhaustion: Characterized by heavy sweating, weakness, dizziness, nausea, headache, and a rapid pulse. If not addressed, this can quickly progress.
- Heatstroke: This is a medical emergency. Symptoms include a very high body temperature (often above 104°F), hot and dry skin (though sweating may still be present in some cases), confusion, disorientation, slurred speech, seizures, and even loss of consciousness or coma. Heatstroke can cause permanent organ damage, including to the brain, kidneys, and liver, and in extreme cases, it can be fatal. The FDA’s review identified 13 cases of hyperthermia associated with the scopolamine patch, tragically resulting in two deaths, one child and one older adult, and four hospitalizations.
Most of these serious cases developed within 72 hours of applying the patch, and often involved vulnerable populations such as children (under 17) and older adults (over 60) who may be more susceptible to disruptions in body temperature control. It’s crucial to note that while Transderm Scop is not FDA-approved for pediatric use, it is sometimes prescribed off-label for children with neurological conditions to manage excessive drooling. The FDA emphasizes that patients should apply only one patch at a time and should never cut the patches, as this can lead to an uncontrolled release of the medication and increase the risk of adverse effects.
What to Do If You Suspect Hyperthermia
If you, or someone you care for, are using a scopolamine patch and experience any symptoms of hyperthermia—such as an unexplained increase in body temperature, reduced sweating (especially in warm conditions), dizziness, confusion, or unusual behavior—remove the patch immediately and seek prompt medical attention. Do not delay. Symptoms of hyperthermia may persist even after the patch is removed, as the medication can remain in the body for hours to days. It is also advised to avoid external heat sources, such as heated blankets, while using the patch.Beyond Hyperthermia:
Other Scopolamine Patch Side Effects
While hyperthermia is a newly highlighted, serious concern, it’s also important to be aware of other common scopolamine patch side effects. As an anticholinergic drug, scopolamine can produce a range of effects due to its mechanism of action. These commonly include:
- Dry mouth: This is one of the most frequently reported side effects.
- Drowsiness and dizziness: These effects can impair your ability to drive or operate machinery safely.
- Blurred vision or dilated pupils: Your vision may be temporarily affected.
- Confusion, agitation, or disorientation: Particularly in older adults, these cognitive side effects can be more pronounced.
- Urinary retention: Difficulty or inability to empty the bladder.
- Constipation: A common digestive side effect.
- Withdrawal symptoms: If used for several days, some individuals may experience withdrawal symptoms upon patch removal, including dizziness, headache, nausea, and balance disturbances. These typically appear about 24 hours after removal.
The FDA’s full Drug Safety Communication provides comprehensive details and recommendations for patients and healthcare professionals. You can find the official warning here: FDA adds warning about serious risk of heat-related complications with antinausea patch Transderm Scōp (scopolamine transdermal system).
Always discuss any concerns about medications with your healthcare provider. Understanding the risks and knowing what to watch for can make a critical difference in your health and safety when using a scopolamine patch.
If you or someone you care for was injured after using a scopolamine patch, click here for a free consultation with the experienced drug litigation attorneys of Ragsdale LLC. Or give us a free call at 205-290-6800. You may be eligible for substantial money damages. And we never charge a fee unless you collect.
