FDA warns of seizure risk with dalfampridine
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FDA warns of seizure risk with dalfampridine The US FDA has issued a drug safety communication advising healthcare professionals and patients of the risk of seizures in patients taking dalfampridine [Ampyra] for multiple sclerosis. Evaluation of post-marketing adverse event case reports received by the FDA indicated that the majority of seizures occurred within days or weeks of starting treatment with dalfampridine at the recommended dose, and that most cases involved patients with no prior history of seizures. As the risk of seizures increases with higher blood concentrations of dalfampridine, the FDA is updating product labelling to clarify recommendations that renal function be assessed before starting treatment and at least yearly during treatment; furthermore, patients who miss a dose are advised not to take extra doses. Dalfampridine should be discontinued following a seizure. Dalfampridine is contraindicated in patients with severe renal impairment (creatinine clearance [CrCl] ≤ 50 mL/min), and physicians are advised to carefully consider the risks and benefits before its use in patients with mild renal impairment (CrCl 51–80 mL/min). Due to the prevalence of mild renal impairment in people aged > 50 years, including those with normal serum creatinine levels, the FDA specifies that CrCl measurements should be used to assess renal function. US FDA. FDA Drug Safety Communication: Seizure risk for multiple sclerosis patients who take Ampyra (dalfampridine). Internet Document : [2 pages], 23 Jul 803074459 2012. Available from: URL: http://www.fda.gov
0114-9954/10/1412-0001/$14.95 Adis © 2010 Springer International Publishing AG. All rights reserved
Reactions 28 Jul 2012 No. 1412
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