Important safety information about Vimpat in the U.S.
Vimpat tablets are indicated as adjunctive therapy in the treatment of partial-onset seizures in patients with epilepsy who are 17 years and older. Vimpat injection is indicated as short-term replacement when oral administration is not feasible in these patients. Patients should be advised that Vimpat may cause dizziness, ataxia, and syncope. Caution is advised for patients with known cardiac conduction problems, who are taking drugs known to induce PR interval prolongation, or with severe cardiac disease. In patients with seizure disorders, Vimpat should be gradually withdrawn to minimize the potential of increased seizure frequency. Multiorgan hypersensitivity reactions have been reported with antiepileptic drugs. If this reaction is suspected, treatment with Vimpat should be discontinued.
AEDs increase the risk of suicidal behavior and ideation. Patients taking Vimpat should be monitored for the emergence or worsening of depression, suicidal thoughts or behavior, and/or any unusual changes in mood or behavior.
The most common adverse reactions occurring in greater than or equal to 10 percent of Vimpat-treated patients, and greater than placebo, were dizziness, headache, nausea, and diplopia.
For more information, and prescribing information visit www.Vimpat.com or contact UCB at (800) 477-7877.
Vimpat(R) is a registered trademark under license from Harris FRC Corporation.
For further information Andrea Levin, Public Relations Manager, CNS, UCB Phone: 770-970-8352 Em
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