Side Effects

Studies demonstrate that side effects of VNS Therapy treatment are mild to moderate, stimulation-related and decrease over time. Also, side effects are not related to many of the side effects typically seen with other epilepsy treatments.¹ Tolerability may be improved by the adjustment of parameter settings during office visits.¹

The most common side effects of VNS Therapy generally occur only during stimulation periods. They include hoarseness, paresthesia, shortness of breath and a dry cough.² The good news is these side effects usually diminish over time as shown on the bar chart.²
 

Patients and caregivers may use the magnet to manage side effects as needed.³

¹Schachter SC et al. Epilepsia. 1998; 39:677-686.
²Morris GL et al. Neurology. 1999; 53:1731-1735.
³Boon P et al. J.Clin.Neurophysiol. 2001; 18:402-407.
 

Safety Profile

VNS Therapy provides a unique, favourable safety and tolerability profile.

Many of the common concerns associated with drug treatment (sleeplessness, confusion, weight gain, memory loss) are not experienced with VNS Therapy. Therefore, VNS Therapy may be added to any AED regimen for improved seizure control and quality-of-life benefits without increasing the CNS side effects of the current drug treatment.

VNS Therapy is not associated with

• interactivity toxicity^1,2
• pharmacokinetic interactions²
• systemic neurotoxic effects²
• idiosyncratic reactions (rash, renal impairment, bone marrow suppression etc.)²

Animal studies have revealed no evidence of impaired fertility or harm to the foetus due to VNS Therapy.³
Based on these studies, the FDA granted approval to update labelling regarding VNS Therapy safety in women of childbearing age.

The unique safety profile of VNS Therapy can be particularly important for special populations or for patients with other medical conditions which co-present with epilepsy. It contributes to quality-of-life benefits.⁴

¹Henry TR. Neurology. 2002; 59 (suppl.4):S3-S14.
²Gates J, Huf R, Frost M. Epilepsy & Behavior. 2001; 2:563-567.
³Physician’s Manual: VNS Therapy Pulse Model 102 Generator. Houston, Texas: Cyberonics Inc.; 2003.
⁴Wheless JW et al. Neurology. 2002; 59 (suppl.4):S21-S25.
 

For more information on the VNS Therapy for pharmacoresistant epilepsy please contact us or visit the Cyberonics website.