Acode 50 Adverse Reactions

List of adverse reactions: The following shows the frequencies of adverse reactions by system organ class which have been reported in clinical trials. The frequencies are defined as follows: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100). Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
Psychiatric disorders: Common: depression, confusional state, insomnia.
Nervous system disorders: Very common: dizziness, headache.
Common: cognitive disorder, nystagmus, balance disorder, coordination abnormal, memory impairment, tremor, somnolence, dysarthria, disturbance in attention, hypoesthesia, paresthesia.
Eye disorders: Very common: diplopia.
Common: vision blurred.
Ear and labyrinth disorders: Common: vertigo, tinnitus.
Gastrointestinal disorders: Very common: nausea.
Common: vomiting, constipation, flatulence, dyspepsia, dry mouth, diarrhea.
Skin and subcutaneous tissue disorders: Common: pruritus.
Musculoskeletal and connective tissue disorders: Common: muscle spasms.
General disorders and administration site conditions: Common: gait disturbance, asthenia, fatigue, irritability, feeling drunk.
Injury, poisoning and procedural complications: Common: fall, skin laceration, confusion.
Description of selected adverse reactions: The use of lacosamide is associated with dose-related increase in the PR interval. Adverse reactions associated with PR interval prolongation (e.g., atrioventricular block, syncope, bradycardia) may occur. In epilepsy patients the incidence rate of reported first degree AV Block is uncommon, 0.7%, 0%, 0.5% and 0% for lacosamide 200 mg, 400 mg, 600 mg or placebo, respectively. No second- or higher-degree AV Block was seen in lacosamide treated epilepsy patients.
The incidence rate for syncope is uncommon and did not differ between lacosamide treated epilepsy patients (0.1%) and placebo treated epilepsy (0.3%).
Atrial fibrillation or flutter were not reported in short term clinical trials; however, both have been reported in open-label epilepsy trials and in post-marketing experience.
Laboratory abnormalities: Abnormalities in liver function tests have been observed in controlled trials with lacosamide in adult patients with partial-onset seizures who were taking 1 to 3 concomitant antiepileptic drugs. Elevations of ALT to ≥3x ULN occurred in 0.7% (7/935) of Lacosamide patients and 0% (0/356) of placebo patients.
Loading dose administration: Incidence of CNS adverse reactions such as dizziness may be higher after a loading dose.
Post-marketing experience: In addition to the adverse reactions reported during clinical studies and listed previously, the following adverse reactions have been reported in post-marketing experience. Data are insufficient to support an estimate of their incidence in the population to be treated.
Blood and lymphatic system disorders: Agranulocytisos.
Immune system disorders: Multiorgan hypersensitivity reactions (also known as Drug Reaction with Eosinophilia and Systemic Symptoms, DRESS) have been reported in patients treated with some antiepileptic agents. These reactions are variable in expression but typically present with fever and rash and can be associated with involvement of different organ systems. Potential cases have been reported rarely with lacosamide and if multiorgan hypersensitivity reaction is suspected, lacosamide should be discontinued.
Nervous system disorders: Seizure. Very few cases of seizure worsening (including occurrence of status epilepticus) have been reported.
Psychiatric disorders: Suicide attempt, suicidal ideation, psychotic disorder, hallucination, aggression, agitation, insomnia, euphoric mood.
Cardiac disorders: Atrioventricular block, atrial flutter, atrial fibrillation, bradycardia.
Hepatobiliary disorders: Liver function test abnormal, hepatic enzyme increased (>2x ULN).
Skin and subcutaneous tissue disorders: Toxic epidermal necrolysis, Stevens-Johnson syndrome, angioedema, urticaria, rash.