Common adverse reactions reported by patients taking Onfi compared to those taking an inactive tablet (placebo) included somnolence, sedation, fever, drooling, constipation, cough, urinary tract infection, sleeplessness (insomnia), aggression, fatigue, upper respiratory tract infection, irritability, vomiting, problems swallowing (dysphagia), problems with coordination (ataxia), bronchitis, and pneumonia.
Like other antiepileptic drugs, Onfi may increase the risk of suicidal thoughts or behaviors in a very small number of people taking the drug. Patients taking antiepileptic drugs should be monitored for depression, suicidal thoughts or behavior, and unusual changes in mood or behavior.
Onfi may slow thinking and impair motor skills; so, it is important that people taking the drug not drive, operate heavy machinery, or engage in other dangerous activities until they know how the drug affects them. Onfi can cause abuse and dependence. It has been categorized as a Schedule IV drug under the Controlled Substances Act. Onfi should not be discontinued suddenly. People using the drug should talk with their health care professional about slowly stopping the drug to avoid withdrawal symptoms.
The FDA is requiring that a Medication Guide be given to patients and caregivers when Onfi is dispensed. The Medication Guide describes the risks and adverse reactions people should be mindful of when using the product.
Onfi is manufactured by Catalent Pharma Solutions LLC, Winchester, Ky., for Lundbeck Inc. of Deerfield, Ill.
|SOURCE U.S. Food and Drug Administration|
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