"The U.S. Food and Drug Administration today approved a device to help reduce the frequency of seizures in epilepsy patients who have not responded well to medications.
The RNS Stimulator consists of a small neurostimulator implanted within "...
Vimpat Side Effects Center
Medical Editor: John P. Cunha, DO, FACOEP
Vimpat (lacosamide) is used together with other medications to treat partial-onset seizures in people with epilepsy who are at least 17 years old. It is an antiepileptic drug. Common side effects include dizziness, drowsiness, blurred/double vision, nausea, vomiting, tiredness, loss of balance, difficulty walking, shakiness (tremor), or memory problems. These side effects are more common when you first start taking the drug and usually lessen as your body adjusts to the medication. You may have suicidal thoughts while taking this medication. Tell your doctor if this occurs.
Dosage of Vimpat is based on the patient's medical condition and response to treatment. There may be other drugs that can interact with Vimpat. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor. During pregnancy, Vimpat should be used only when prescribed. It is not known whether this drug passes into breast milk and the effect on a nursing infant is unknown. Consult your doctor before breast-feeding.
Our Vimpat (lacosamide) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What is Patient Information in Detail?
Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.
Vimpat in Detail - Patient Information: Side Effects
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Report any new or worsening symptoms to your doctor, such as: mood or behavior changes, depression, anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), or have thoughts about suicide or hurting yourself.
Stop using lacosamide and call your doctor at once if you have a serious side effect such as:
- double vision;
- feeling like you might pass out;
- fast or pounding heartbeats, fluttering in your chest;
- feeling short of breath;
- fever, skin rash, swollen glands, flu symptoms;
- bruising, severe tingling, numbness, pain, muscle weakness;
- nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes); or
- lower back pain, cloudy or bloody urine, swelling, rapid weight gain, urinating less than usual.
Less serious side effects may include:
- dizziness, spinning sensation;
- loss of balance or coordination;
- blurred vision;
- nausea, vomiting;
- drowsiness, tired feeling; or
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1 800 FDA 1088.
Read the entire detailed patient monograph for Vimpat (Lacosamide Tablet and Injection)
What is Patient Information Overview?
A concise overview of the drug for the patient or caregiver from First DataBank.
Vimpat Overview - Patient Information: Side Effects
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
Seek immediate medical attention if any of these rare but serious side effects occur: fast/slow/irregular/pounding heartbeat, shortness of breath, severe dizziness, fainting.
A small number of people who take anticonvulsants for any condition (such as seizure, bipolar disorder, pain) may experience depression, suicidal thoughts/attempts, or other mental/mood problems. Tell your doctor immediately if you or your family/caregiver notice any unusual/sudden changes in your mood, thoughts, or behavior including signs of depression, suicidal thoughts/attempts, thoughts about harming yourself.
This medication may rarely cause a serious immune system problem (Drug Reaction with Eosinophilia and Systemic Symptoms). Tell your doctor immediately if you experience any of these unlikely but serious side effects: unusual fever, swollen glands, yellowing skin/eyes, unusual tiredness, dark urine, severe stomach/abdominal pain, change in amount of urine, side/back pain (flank pain), bloody/pink urine, chest pain.
A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any of the following symptoms of a serious allergic reaction: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
In the US -
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Read the entire patient information overview for Vimpat (Lacosamide Tablet and Injection)
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Vimpat FDA Prescribing Information: Side Effects
Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
In the premarketing development of adjunctive therapy for partial onset seizures, 1327 patients received VIMPAT in controlled and uncontrolled trials, of whom 1000 were treated for longer than 6 months, and 852 for longer than 12 months. The monotherapy development program included 425 patients, 310 of whom were treated for longer than 6 months, and 254 for longer than 12 months.
VIMPAT Tablet and Oral solution
Monotherapy Historical-Control Trial (Study 1)
In the monotherapy trial, 16% of patients randomized to receive VIMPAT at the recommended doses of 300 and 400 mg/day discontinued from the trial as a result of an adverse event. The adverse reaction most commonly ( ≥ 1% on VIMPAT) leading to discontinuation was dizziness.
Adverse reactions observed in this study were generally similar to those observed and attributed to drug in adjunctive placebo-controlled studies. One adverse reaction, insomnia, was observed at a rate of ≥ 2% and was not reported at a similar rate in previous studies. This adverse reaction has also been observed in postmarketing experience [see ADVERSE REACTIONS]. Because this study did not include a placebo control group, causality could not be established.
Dizziness, headache, nausea, somnolence, and fatigue were all reported at lower incidences during the AED Withdrawal Phase and Monotherapy Phase, compared with the Titration Phase [see Clinical Studies].
Adjunctive TherapyControlled Trials (Studies2, 3, and 4)
In adjunctive therapy controlled clinical trials, the rate of discontinuation as a result of an adverse event was 8% and 17% in patients randomized to receive VIMPAT at the recommended doses of 200 and 400 mg/day, respectively, 29% at 600 mg/day, and 5% in patients randomized to receive placebo. The adverse events most commonly ( > 1% on VIMPAT and greater than placebo) leading to discontinuation were dizziness, ataxia, vomiting, diplopia, nausea, vertigo, and vision blurred.
Table 2 gives the incidence of treatment-emergent adverse events that occurred in ≥ 2% of adult patients with partial-onset seizures in the VIMPAT total group and for which the incidence was greater than placebo. The majority of adverse events in the VIMPAT patients were reported with a maximum intensity of 'mild' or 'moderate'.
Table 2: Treatment-Emergent Adverse Event Incidence in
Adjunctive Therapy Double-Blind, Placebo-Controlled Partial-Onset Seizure
Trials (Events ≥ 2% of Patients in VIMPAT Total Group and More Frequent
Than in the Placebo Group)
|System Organ Class/ Preferred Term||Placebo
|VIMPAT 200 mg/day
|VIMPAT 400 mg/day
|VIMPAT 600 mg/day
|Ear and labyrinth disorder|
|General disorders and administration site conditions|
|Gait disturbance||< 1||< 1||2||4||2|
|Injury, poisoning and procedural complications|
|Nervous system disorders|
|Skin and subcutaneous disorders|
The overall adverse event rate was similar in male and female patients. Although there were few non-Caucasian patients, no differences in the incidences of adverse events compared to Caucasian patients were observed.
Abnormalities in liver function tests have been observed in controlled trials with VIMPAT in adult patients with partial-onset seizures who were taking 1 to 3 concomitant anti-epileptic drugs. Elevations of ALT to ≥ 3× ULN occurred in 0.7% (7/935) of VIMPAT patients and 0% (0/356) of placebo patients. One case of hepatitis with transaminases > 20x ULN was observed in one healthy subject 10 days after VIMPAT treatment completion, along with nephritis (proteinuria and urine casts). Serologic studies were negative for viral hepatitis. Transaminases returned to normal within one month without specific treatment. At the time of this event, bilirubin was normal. The hepatitis/nephritis was interpreted as a delayed hypersensitivity reaction to VIMPAT.
Other Adverse Reactions
The following is a list of treatment-emergent adverse reactions reported by patients treated with VIMPAT in all clinical trials in patients with partial-onset seizures, including controlled trials and long-term open-label extension trials. Events addressed in other tables or sections are not listed here. Events included in this list from the controlled trials occurred more frequently on drug than on placebo and were based on consideration of VIMPAT pharmacology, frequency above that expected in the population, seriousness, and likelihood of a relationship to VIMPAT. Events are further classified within system organ class.
Cardiac disorders: palpitations
Ear and labyrinth disorders: tinnitus
General disorders and administration site conditions: irritability, pyrexia, feeling drunk
Injury, poisoning, and procedural complications: fall
Musculoskeletal and connective tissue disorders: muscle spasms
Psychiatric disorders: confusional state, mood altered, depressed mood
Adverse reactions with intravenous administration generally were similar to those observed with the oral formulation, although intravenous administration was associated with local adverse events such as injection site pain or discomfort (2.5%), irritation (1%), and erythema (0.5%). One case of profound bradycardia (26 bpm: BP 100/60 mmHg) was observed in a patient during a 15-minute infusion of 150 mg VIMPAT. This patient was on a beta-blocker. Infusion was discontinued and the patient experienced a rapid recovery.
The safety of a 15-minute loading dose administration of VIMPAT Injection 200 mg to 400 mg followed by oral administration of VIMPAT given twice daily at the same total daily dose as the initial intravenous infusion was assessed in an open-label study in patients with partial onset seizures. Patients had to have been maintained on a stable dose regimen of 1 to 2 marketed antiepileptics for at least 28 days prior to treatment assignment. Treatment groups were as follows:
- Single dose of intravenous VIMPAT Injection 200 mg followed by oral VIMPAT 200 mg/day (100 mg every 12 hours)
- Single dose of intravenous VIMPAT Injection 300 mg followed by oral VIMPAT 300 mg/day (150 mg every 12 hours)
- Single dose of intravenous VIMPAT Injection 400 mg followed by oral VIMPAT 400 mg/day (200 mg every 12 hours).
- Table 3 gives the incidence of adverse events that occurred in ≥ 5% of adult patients in any VIMPAT dosing group.
Table 3: Incidence of Treatment-Emergent Adverse
Events in 15-minute infusion study (Events ≥ 5% of subjects in any VIMPAT
|System Organ Class/Preferred term||VIMPAT 200 mg
|VIMPAT 300 mg
|VIMPAT 400 mg
|General disorders/administration site conditions|
|Nervous system disorders|
|Skin & subcutaneous tissue disorders|
Adverse events observed with infusion of VIMPAT 200 mg over 15-minutes followed by VIMPAT 100 mg administered orally twice day were similar in frequency to those observed in 3-month adjunctive therapy controlled trials. Considering the difference in period of observations (1 week vs. 3 months), the incidence of CNS adverse reactions, such as dizziness, somnolence, and paresthesia may be higher with 15-minute administration of VIMPAT Injection than with administration over a 30-to 60minute period.
The following adverse reactions have been identified during post-approval use of VIMPAT. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Blood and lymphatic system disorders: Agranulocytosis
Psychiatric disorders: Aggression, agitation, hallucination, insomnia, psychotic disorder
Read the entire FDA prescribing information for Vimpat (Lacosamide Tablet and Injection)
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