![]() ![]() The relative risk for suicidal thoughts or behavior was higher in clinical trials in patients with epilepsy than in clinical trials in patients with psychiatric or other conditions, but the absolute risk differences were similar for epilepsy and psychiatric indications.Īnyone considering prescribing APTIOM or any other AED must balance this risk with the risk of untreated illness. Risk Differences: Additional Drug Patients with Events Per 1000 Patients Relative Risk: Incidence of Events in Drug Patients/Incidence in Placebo Patients Placebo Patients with Events Per 1000 Patientsĭrug Patients with Events Per 1000 Patients Table 3: Risk of Suicidal Thoughts or Behaviors by Indication for Antiepileptic Drugs in the Pooled Analysis ![]() Table 3 shows absolute and relative risk by indication for all evaluated AEDs. The risk did not vary substantially by age (5-100 years) in the clinical trials analyzed. The finding of increased risk with AEDs of varying mechanisms of action and across a range of indications suggests that the risk applies to all AEDs used for any indication. The risk of suicidal thoughts or behavior was generally consistent among drugs in the data analyzed. Because most trials included in the analysis did not extend beyond 24 weeks, the risk of suicidal thoughts or behavior beyond 24 weeks could not be assessed. The increased risk of suicidal thoughts or behavior with AEDs was observed as early as one week after starting treatment with AEDs and persisted for the duration of treatment assessed. There were four suicides in drug-treated patients in the trials and none in placebo-treated patients, but the number of events is too small to allow any conclusion about drug effect on suicide. ![]() In these trials, which had a median treatment duration of 12 weeks, the estimated incidence of suicidal behavior or ideation among 27,863 AED-treated patients was 0.43%, compared to 0.24% among 16,029 placebo-treated patients, representing an increase of approximately one case of suicidal thinking or behavior for every 530 patients treated. 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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