FDA cautions about lamotrigine, aseptic meningitis link

Lamotrigine (Lamictal), a medication commonly used for epilepsy, may be linked with aseptic meningitis, FDA officials cautioned this week.

The agency urged a label change after the drug’s manufacturer, GlaxoSmithKline, provided routine surveillance data that noted 40 cases of aseptic meningitis between December 1994 and November 2009 in patients taking the medication. Symptom onset began within 1 to 42 days, with a mean of 16 days, of initiating treatment.

Thirty-five patients required hospitalization, although most experienced symptom resolution upon medication discontinuation. Fifteen cases, however, reported return of symptoms within 1 to 24 hours after the drug was reintroduced.

Analysis of cerebrospinal fluid was performed in 25 cases, the FDA said. Results revealed the presence of a mild to moderate pleocytosis, normal glucose levels and a mild to moderate increase in protein. White blood cell count differentials also indicated a predominance of neutrophils in most cases, and a predominance of lymphocytes in approximately one-third of cases.

Agency officials noted that some patients taking the drug who developed meningitis also had underlying diagnoses of systemic lupus erythematosus or other autoimmune diseases. Other data suggested that symptoms may have been partially associated with a hypersensitivity or generalized drug reaction.

The FDA advised health care professionals to first examine patients presenting with symptoms of meningitis for other causes, and, consider discontinuation of Lamictal if other causes are ruled out.

Lamictal is currently available as an orally disintegrating tablet (Lamictal ODT), a chewable, dispersible tablet (Lamictal CD) and an extended release product (Lamictal XR).

Lamotrigine (Lamictal), a medication commonly used for epilepsy, may be linked with aseptic meningitis, FDA officials cautioned this week.

The agency urged a label change after the drug’s manufacturer, GlaxoSmithKline, provided routine surveillance data that noted 40 cases of aseptic meningitis between December 1994 and November 2009 in patients taking the medication. Symptom onset began within 1 to 42 days, with a mean of 16 days, of initiating treatment.

Thirty-five patients required hospitalization, although most experienced symptom resolution upon medication discontinuation. Fifteen cases, however, reported return of symptoms within 1 to 24 hours after the drug was reintroduced.

Analysis of cerebrospinal fluid was performed in 25 cases, the FDA said. Results revealed the presence of a mild to moderate pleocytosis, normal glucose levels and a mild to moderate increase in protein. White blood cell count differentials also indicated a predominance of neutrophils in most cases, and a predominance of lymphocytes in approximately one-third of cases.

Agency officials noted that some patients taking the drug who developed meningitis also had underlying diagnoses of systemic lupus erythematosus or other autoimmune diseases. Other data suggested that symptoms may have been partially associated with a hypersensitivity or generalized drug reaction.

The FDA advised health care professionals to first examine patients presenting with symptoms of meningitis for other causes, and, consider discontinuation of Lamictal if other causes are ruled out.

Lamictal is currently available as an orally disintegrating tablet (Lamictal ODT), a chewable, dispersible tablet (Lamictal CD) and an extended release product (Lamictal XR).