Abstracts

Rationale: There are many known risk factors for psychogenic non-epileptic seizures (PNES), but little known about medications associated with PNES as an adverse effect. The United States Food and Drug Administration (FDA) launched openFDA on June 2, 2014, allowing public access to FDA datasets.¹ OpenFDA currently features a dataset of all drug adverse event reports to the FDA since 2004.¹ Although openFDA requires use of a search-based Application Program Interface (API), the ResearchAE.com application allows search of the dataset without knowledge of programming code.² Use of this dataset allows for potential discovery of novel associations between drugs and adverse effects not previously reported. On literature review, we found that PNES can be induced by intravenous saline placebo³ but to our knowledge, this is the first study to evaluate medication types implicated in psychogenic seizures. Methods: We performed a search on ResearchAE.com to include all reported cases of PNES as an adverse effect. The search included the entirety of the presently available FDA data (06/29/2003 to 06/11/2014) in adults aged 18 and older, using the term "psychogenic." No other form of the term "psychogenic seizure" could be found in the database (e.g., "pseudoseizure" or "non-epileptic"). For each report, we recorded the implicated drug, patient age, patient sex, entire list of reported adverse events (in addition to "psychogenic seizure"), drug indication, report submitter (e.g., physician, consumer, etc.), and presence of concurrent seizure medication use. Results: Manual review of query results yielded 20 reports of drugs reportedly associated with "psychogenic seizure" as an adverse effect in 19 patients. The average patient age was 48 years, with 79% female. Other than "psychogenic seizure," other commonly associated drug adverse effects within the same reports included "convulsion," "fatigue," "pain," and "tremor." Implicated drugs most commonly included multiple sclerosis disease modifying drugs (6 occurrences), disease modifying anti-rheumatic drugs (5 occurrences), anti-seizure drugs (4 occurrences), and psychiatric drugs (2 occurrences). Five reports were submitted by the consumer or other non-health professional while 15 were submitted by a health professional. Conclusions: This novel study reveals that over an 11-year period, there have been reports to the FDA of 20 drugs suspected to be associated with subsequent PNES. Although causation cannot be assumed, over 50% of reports were of multiple sclerosis disease modifying drugs or disease modifying anti-rheumatic drugs; this association warrants further investigation. References: 1. openFDA. U.S. Food and Drug Administration. https://open.fda.gov/about. Accessed June 11, 2014. 2. ResearchAE.com. http://www.researchae.com. Accessed June 11, 2014. 3. Slater JD, Brown MC, Jacobs W, Ramsay RE. Induction of pseudoseizures with intravenous saline placebo. Epilepsia. 1995;36(6):580-585.