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Report describes potential problem with new drug for seizures, pain

A report in the July Annals of Neurology describes a serious adverse event experienced by a participant in a clinical trial that may raise a new caution about the use of antiepileptic drugs for conditions other than epilepsy. An elderly women enrolled in a clinical trial of pregabalin, a new drug for the treatment of pain and seizures, abruptly discontinued the medication and then developed neurological symptoms including headache, confusion and hallucinations. The study's authors from Massachusetts General Hospital (MGH) suggest that all patients stopping antiepileptic drugs (AEDs) should do so gradually to avoid complications of withdrawal.

"The first description of complications associated with a new drug the 'index case' lets doctors and patients know of the potential for problems," says Anne Louise Oaklander, MD, PhD, director of the MGH Nerve Injury Unit and the report's lead author. "It doesn't tell us whether these problems are very rare or common, but it lets everyone know to look out for more cases. There are many questions that still need to be answered, but right now our recommendations are that anyone using AEDs not stop them abruptly until the risks and consequences are better known."

Patients with epilepsy have traditionally been cautioned against suddenly halting drug treatment because abrupt withdrawal could trigger the resumption of seizures. In recent years, however, AEDs have been prescribed for many other conditions including pain syndromes and psychiatric disorders and recommendations against rapid withdrawal were not thought to apply to those patients.

In the current report, Oaklander and her coauthor Bradley Buchbinder, MD, an MGH neuroradiologist, describe the experiences of an 80-year-old women who took pregabalin as part of a clinical trial of the drug for treatment of post-herpetic neuralgia, a painful syndrome that can linger after shingles. After she had taken the drug for almost a year, with good
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Contact: Sue McGreevey
smcgreevey@partners.org
617-724-2764
Massachusetts General Hospital
6-Jul-2005


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