FierceBiotech FierceBiotech IT FiercePharma FierceMedicalDevices
FierceBiotech Research FierceVaccines FiercePharma Manufacturing FierceDrugDelivery

Free Newsletter

About | View Sample | Privacy
Related Topics >> GlaxoSmithKline | drug safety | Lamictal

FDA: GSK seizure drug linked to meningitis

Concerned by a string of reports over the past 16 years that the anti-seizure drug Lamictal can cause aseptic meningitis in rare instances, the FDA has flagged their concerns to physicians and plans to revise the label with GlaxoSmithKline (NYSE: GSK).

"Aseptic meningitis is a rare but serious side effect of Lamictal use," says Russell Katz, director of the Division of Neurology Products in the FDA's Center for Drug Evaluation and Research. "Patients that experience symptoms should consult their health care professional immediately."

Only 35 known cases of meningitis led to hospitalization since 1994, but regulators want to make sure physicians who prescribe the drug know that it can trigger dangerous inflammation of the brain and spinal cord, usually within six weeks of initial dosing. Quick treatment with pain medications can typically resolve the cases inside of two weeks. Lamictal has been a steady earner for GSK, garnering $778 million in sales last year.  

- read the FDA's release
- here's the report from the Press Association

Related Articles:
NEJM study cuts epilepsy meds' link to suicide
Novartis, GSK meds get expanded indications
Tweaked Glaxo drugs mired in approval delays


SHARE
WITH:
Email Twitter Facebook LinkedIn StumbleUpon
Get Your FREE FiercePharma Email Newsletter:

More stories about GlaxoSmithKline   drug safety   Lamictal