MEDWATCH: Varenicline and others

Apud Mario de Camargo Maranhão Drugs and Therapeutic Biological Products (CDER): Varenicline (marketed as Chantix) (posted 02/01/2008)     = Adobe Acrobat file (.pdf file), viewed with free Acrobat Reader software. For more information, go to the MedWatch "downloads" page at http://www.fda.gov/MedWatch/getforms.htm

 

Varenicline (marketed as Chantix) Audience: Neuropsychiatric and other healthcare professionals, consumers [Posted 02/01/2008] FDA informed healthcare professionals and consumers of important revisions to the WARNINGS and PRECAUTIONS sections of the prescribing information for Chantix regarding serious neuropsychiatric symptoms experienced in patients taking Chantix. These symptoms include changes in behavior, agitation, depressed mood, suicidal ideation, and attempted and completed suicide. While some patients may have experienced these types of symptoms and events as a result of nicotine withdrawal, some patients taking Chantix who experienced serious neuropsychiatric symptoms and events had not yet discontinued smoking. In most cases, neuropsychiatric symptoms developed during Chantix treatment, but in others, symptoms developed following withdrawal of Chantix therapy. See the FDA Information for Healthcare Professionals Sheet for recommendations and considerations for healthcare professionals on using Chantix therapy for patients. [February 01, 2008 - Public Health Advisory - FDA] [February 01, 2008 - Prescribing Information - Pfizer] [February 01, 2008 - Healthcare Professional Information Sheet - FDA] Return to Top | MedWatch Home | MedWatch Safety Info | Online MedWatch Report | Contact MedWatch   Antiepileptic Drugs Audience: Neuropsychiatric healthcare professionals, other healthcare professionals, patients [Posted 01/31/2008] FDA informed healthcare professionals that the Agency has analyzed reports of suicidality (suicidal behavior or ideation) from placebo-controlled clinical studies of eleven drugs used to treat epilepsy as well as psychiatric disorders, and other conditions. In the FDA's analysis, patients receiving antiepileptic drugs had approximately twice the risk of suicidal behavior or ideation (0.43%) compared to patients receiving placebo (0.22%). The increased risk of suicidal behavior and suicidal ideation was observed as early as one week after starting the antiepileptic drug and continued through 24 weeks. The results were generally consistent among the eleven drugs. The relative risk for suicidality was higher in patients with epilepsy compared to patients who were given one of the drugs in the class for psychiatric or other conditions. Healthcare professionals should closely monitor all patients currently taking or starting any antiepileptic drug for notable changes in behavior that could indicate the emergence or worsening of suicidal thoughts or behavior or depression. The drugs included in the analyses include (some of these drugs are also available in generic form): Carbamazepine (marketed as Carbatrol, Equetro, Tegretol, Tegretol XR) Felbamate (marketed as Felbatol) Gabapentin (marketed as Neurontin) Lamotrigine (marketed as Lamictal) Levetiracetam (marketed as Keppra) Oxcarbazepine (marketed as Trileptal) Pregabalin (marketed as Lyrica) Tiagabine (marketed as Gabitril) Topiramate (marketed as Topamax) Valproate (marketed as Depakote, Depakote ER, Depakene, Depacon) Zonisamide (marketed as Zonegran) Although the 11 drugs listed above were the ones included in the analysis, FDA expects that the increased risk of suicidality is shared by all antiepileptic drugs and anticipates that the class labeling changes will be applied broadly. [January 31, 2008 - Healthcare Professional Information Sheet - FDA] Return to Top | MedWatch Home | MedWatch Safety Info | Online MedWatch Report | Contact MedWatch