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Neurontin®
Serious side effects of NeurontinMost people who take Neurontin have mild side effects that go away without sequelae, or even no side effects at all. Neurontin appears to be an exceptionally safe medicine. Indeed, no life-threatening reactions have been attributed to it. As with any medication, however, a very small number of people (well under 1%) have serious reactions, as described in the package insert. In rare cases, Neurontin has made absence or myoclonic seizures worse. On July 10, 2008, an advisory panel was convened by the Food and Drug Administration (FDA) to review data that the FDA had previously collected from drug studies showing an association between many of the antiepileptic drugs (AEDs) and suicidal ideation and behavior, which together are called suicidality. According to the FDA’s Alert, among the patients with epilepsy in these drug studies, 1 out of 1000 people taking the placebo (inactive substance) showed suicidality compared to approximately 3.5 out of 1000 people who took an AED. The FDA advisory panel voted to accept the FDA's data at its meeting on July 10. The FDA has provided the following information for patients, family members, and caregivers at www.fda.gov/cder/drug/InfoSheets/HCP/antiepilepticsHCP.htm.
We again urge patients and families to contact their doctor before stopping an epilepsy medication because this may possibly lead to seizures and worsening of mood. Reviewed July 2008 by Steven C. Schachter, MD, epilepsy.com Editorial Board. When a patient presents with a serious and/or unexpected adverse reaction from a medication or device, you should consider reporting this event to Medwatch (http://www.fda.gov/medwatch/report/hcp.htm). To download Medwatch reporting forms click here (http://www.fda.gov/medwatch/getforms.htm). |
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