![]() ![]() ![]() Pooled analyses of 199 placebo-controlled clinical trials (mono- and adjunctive therapy) of 11 different AEDs showed that patients randomized to one of the AEDs had approximately twice the risk (adjusted Relative Risk 1.8, 95% confidence interval : 1.2, 2.7) of suicidal thinking or behavior compared to patients randomized to placebo. Patients treated with any AED for any indication should be monitored for the emergence or worsening of depression, suicidal thoughts or behavior, and/or any unusual changes in mood or behavior. * Sections or subsections omitted from the full prescribing information are not listed.Īntiepileptic drugs (AEDs), including APTIOM, increase the risk of suicidal thoughts or behavior in patients taking these drugs for any indication. FULL PRESCRIBING INFORMATION: CONTENTS * 1 INDICATIONS AND USAGEĢ.1 Important Administration InstructionsĢ.3 Dosage Modifications with Other Antiepileptic DrugsĢ.4 Dosage Modifications in Patients with Renal Impairmentĥ.3 Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)/Multiorgan Hypersensitivityĥ.4 Anaphylactic Reactions and AngioedemaĨ.3 Females and Males of Reproductive Potentialġ0.1 Signs, Symptoms, and Laboratory Findings of Acute Overdose in Humansġ3.1 Carcinogenesis, Mutagenesis, Impairment of Fertilityġ4.1 Monotherapy for Partial-Onset Seizuresġ4.2 Adjunctive Therapy for Partial-Onset Seizures ![]()
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