An FDA warning about the risk of aseptic meningitis to epilepsy patients taking lamotrigine (GlaxoSmithKline's Lamictal and generics) could help brand products such as Pfizer's Lyrica (pregabalin) make the case that they are a valuable prescribing option.

"Aseptic meningitis is a rare but serious side effect of Lamictal use," Russell Katz, director of FDA's Division of Neurology Products, said in a statement. From Lamictal's approval date in December 1994 through November 2009, 40 cases of aseptic meningitis were diagnosed in patients taking the drug and reported through routine adverse event monitoring. Twenty-five of those 40 cases were in the U.S.

"The symptoms were reported to occur within one to 42 days after starting Lamictal," FDA said. "Thirty-five of the 40 patients required hospitalization. In most cases, symptoms ended after Lamictal was discontinued. In 15 cases, symptoms, often more severe, returned when patients restarted the drug."

FDA and GSK are updating the label and medication guide for Lamictal, which is indicated for seizures and bipolar disorder. The drug already has a Risk Evaluation and Mitigation Strategy, consisting of the MedGuide, as does Lyrica. In that sense the change for Lamictal is not a huge one, but any additional risk is likely to prove damaging to the drug in the crowded epilepsy market space.

Other antiepileptics without generic equivalents include Schwartz Biosciences' Vimpat (lacosamide) and Eisai's Banzel (rufinamide), approved in October and November 2008, respectively (Also see "FDA Opts For MedGuide, Not Black Box For Anti-Epileptic Suicidality" - Pink Sheet, 24 November, 2008.).

- Martin Berman-Gorvine (m.berman-gorvine@elsevier.com)

GSK Lamictal's New Warning On Aseptic Meningitis May Help Pfizer's Lyrica

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