Can Frisium (clobazam) be used to treat or prevent simple febrile seizures in a healthy child aged 6 months to 5 years, and should it be continued if the child is already taking it?

Frisium (Clobazam) Should NOT Be Used for Simple Febrile Seizures

The American Academy of Pediatrics explicitly recommends against both continuous and intermittent anticonvulsant prophylaxis (including clobazam) for children with simple febrile seizures, as the potential toxicities clearly outweigh the minimal risks. 1, 2

Why Prophylaxis Is Not Recommended

The Harm-Benefit Analysis Strongly Favors No Treatment

• Simple febrile seizures cause no structural brain damage, no decline in IQ, academic performance, or neurocognitive function, and carry an excellent prognosis 1, 2
• The risk of developing epilepsy after simple febrile seizures is approximately 1%—identical to the general population 1, 2
• Even high-risk children (multiple seizures, age <12 months at first seizure, family history of epilepsy) have only 2.4% risk of developing epilepsy by age 25 years 1
• Prophylactic anticonvulsant treatment does not reduce the already-minimal risk of developing epilepsy and does not improve long-term outcomes 1

Recurrence Risk Does Not Justify Treatment

• Children younger than 12 months at first seizure have approximately 50% probability of recurrence; those older than 12 months have approximately 30% probability 1, 2
• Recurrent simple febrile seizures cause no harm and do not warrant prophylactic treatment 1
• Of those who have a second febrile seizure, 50% have at least one additional recurrence, but this still does not justify prophylaxis 1

If Already Taking Clobazam: Discontinue It

If a child with simple febrile seizures is already taking clobazam, it should be tapered and discontinued, as it was inappropriately initiated and provides no benefit in preventing epilepsy development. 1

Risks of Continuing Clobazam

While the research evidence suggests clobazam has fewer adverse effects than diazepam 3, 4, 5, 6, the guideline-level evidence is unequivocal that no intermittent prophylaxis should be used for simple febrile seizures 1, 2:

• Adverse effects reported with clobazam include drowsiness, ataxia, lethargy, irritability, vomiting, hyperactivity, and weakness 3, 4, 5, 6
• The American Academy of Pediatrics states that intermittent diazepam (and by extension, other benzodiazepines like clobazam) may cause lethargy, drowsiness, ataxia, and may mask evolving CNS infection 1
• Any adverse effects from prophylactic medication are unacceptable when the condition being prevented (recurrent simple febrile seizures) causes no harm 1, 2

What TO Do Instead

Acute Management During a Seizure

• Position the child on their side, remove harmful objects, protect the head from injury 1
• Never restrain the child or place anything in the mouth during active seizure activity 1, 2
• Activate emergency services for first-time seizures, seizures lasting >5 minutes, multiple seizures without return to baseline, or seizures with breathing difficulties 2
• For seizures lasting >5 minutes, lorazepam 0.05-0.1 mg/kg IV (maximum 4 mg) is first-line treatment 1

Fever Management

• Use antipyretics (acetaminophen 10-15 mg/kg every 4-6 hours, maximum 5 doses in 24 hours) for the child's comfort 1, 7
• Antipyretics do NOT prevent febrile seizures or reduce recurrence risk—they should only be used to improve comfort and prevent dehydration 1, 2, 7

Parent Education

• Educate caregivers about the benign nature of simple febrile seizures and excellent prognosis 1, 2
• Provide practical home management instructions and when to seek emergency care 1, 2
• Reassure parents that simple febrile seizures do not cause brain damage or learning problems 1, 2

Critical Distinction: Complex Febrile Seizures

The above recommendations apply specifically to simple febrile seizures (generalized, <15 minutes, single episode in 24 hours, temperature ≥100.4°F/38°C, no intracranial infection) 1, 2:

• Complex febrile seizures (duration ≥15 minutes, focal features, or recurrence within 24 hours) may warrant different consideration 2
• For complex febrile seizures, prophylactic intermittent diazepam during febrile illness may be considered according to WHO guidelines, though the American Academy of Pediatrics guidelines do not support routine prophylaxis even for complex cases 2
• Neurological consultation should be requested for prolonged febrile seizures, repetitive focal febrile seizures, or abnormal neurological exam or development 1

Common Pitfall to Avoid

Do not confuse the research showing clobazam's relative efficacy compared to diazepam 3, 4, 5, 6 with a recommendation to use it. The guideline-level evidence from the American Academy of Pediatrics is unequivocal: neither clobazam, diazepam, nor any other intermittent or continuous anticonvulsant should be prescribed for simple febrile seizures 1, 2. The research studies demonstrating clobazam's efficacy were conducted before the harm-benefit analysis clearly established that the risks of any prophylaxis outweigh the benefits 1.