The study reviewed the incidence of falls in 1,480 people with drug-resistant partial seizures and in 163 people with primary generalized tonic-clonic seizures (PGTCS) who were at least 12 years old – excluding patients falling due to seizures – and found a higher proportion of falls among patients taking Fycompa than patients taking a placebo.
The study, “Analysis of falls in patients with epilepsy enrolled in the perampanel phase III randomized double-blind studies,” and was published in the journal Epilepsia.
Fycompa, sold by Eisai, is used in combination with other antiepileptic drugs to treat partial seizures and PGTCS in people with epilepsy who are age 12 and older.
The recommendations are based on the findings of three Phase 3 clinical trials that tested the safety and effectiveness of different dosing regimens of Fycompa in people with drug-resistant partial seizures (NCT00699972, NCT00699582 and NCT00700310) and one Phase 3 trial (NCT01393743) testing the drug in PGTCS.
Results indicate that 5.1% of people with drug-resistant partial seizures did experience falls as a result of their treatment with Fycompa vs. 3.4% of those being treated with a placebo. For people with PGTCS, the proportions were 2.5% vs. 1.2%, respectively. The higher the dosage, the higher the likelihood of falling, the authors noted.
The study’s authors believe their findings suggest that people with epilepsy who are being treated with Fycompa should be closely monitored due to their increased risk of falling, even though, particularly in elderly people, higher doses of Fycompa could also help control seizures and reduce their frequency.
“Clinicians need to be aware of and counsel patients about the potential for an increased risk of falls when treating with perampanel, especially at higher doses,” Ilo Leppik, lead author of the study, said in a press release.
“Appropriate treatment should be individualized by taking the patient profile into consideration,” the team wrote.
Besides being at an increased risk of falling, other side effects associated with Fycompa include feeling dizzy, sleepy, fatigued, aggressive and irritable.