ST LOUIS (MD Consult) - On August 12, 2010, the US Food and Drug Administration (FDA) announced that a revision is being made to the label for Lamictal (lamotrigine), a medication commonly used for the treatment of seizures in children and bipolar disorder in adults. The Warnings and Precautions section of the drug label and the patient medication guide will now include information about a risk for aseptic meningitis.
The decision to revise the Lamictal label was made on the basis of the FDA's identification of 40 cases of aseptic meningitis occurring in patients taking Lamictal (from December 1994 to November 2009). In the affected patients, headache, fever, nausea, vomiting, nuchal rigidity, rash, photophobia, and myalgias were noted. Symptoms occurred 1 to 42 days after initiating Lamictal therapy (mean of 16 days). One death was reported, though the death was not thought to be the result of aseptic meningitis. Thirty-five of the 40 affected patients required hospitalization.
In the majority of cases of aseptic meningitis, symptoms resolved after Lamictal was discontinued. Fifteen patients experienced a rapid return of symptoms after reinitiation of Lamictal therapy (ie, 30 minutes to 24 hours, mean of 5 hours). In these rechallenge cases, symptoms were frequently more severe after reexposure to the drug.
It should be noted that some of the patients treated with Lamictal in whom aseptic meningitis developed had underlying diagnoses of systemic lupus erythematosus or other autoimmune diseases. In addition, some patients experienced a new onset of signs and symptoms of involvement of other organs (predominantly hepatic and renal involvement), which may suggest that some of the cases of Lamictal-associated meningitis were part of a hypersensitivity or generalized drug reaction.
Health care professionals who prescribe Lamictal should be aware that if meningitis is suspected, patients should also be evaluated for other causes of meningitis and treated as indicated. Discontinuation of Lamictal should be considered if no other clear cause of meningitis is identified.
The FDA announcement also mentioned that during the same time period in which the cases of aseptic meningitis were reported, it is estimated that more than 46 million prescriptions for Lamictal were dispensed.
圣路易斯(MD Consult)—2010年8月12日，美国食品药品管理局(FDA)宣布正敦促生产商对小儿癫痫和成人双相情感障碍的常用治疗药Lamictal(拉莫三嗪)的说明书进行修改。修改后的药品说明书的警告和注意事项部分以及患者用药指导将包括有关无菌性脑膜炎风险的信息。
修改Lamictal说明书这一决定的起因是自1994年12月~2009年11月， FDA在服用拉莫三嗪的患者中查出40例无菌性脑膜炎。在这些患者中观察到的症状有头痛、发热、恶心、呕吐、颈项强直、湿疹、畏光和肌肉疼痛。症状出现在开始Lamictal治疗后的1~42天(平均16天)。尽管死亡并不被视为无菌性脑膜炎的结局，但仍有1例死亡报告。这40例中有35例需住院治疗。
大多数无菌性脑膜炎病例在停用Lamictal后症状消失。15例在重新开始使用后症状快速重现(30min~24h，平均5h)且更为严重。
应注意的是，某些发生无菌性脑膜炎同时服用Lamictal的患者还存在系统性红斑狼疮或其他自身免疫性疾病的潜在诊断。此外，部分患者在其他脏器(主要为肝肾受累)出现新的症状和体征，这表明某些Lamictal相关性脑膜炎是超敏反应或全身性药物反应的部分表现。
对Lamictal开处方的医护专业人员应知道，如果疑似为脑膜炎，还应对患者脑膜炎的其他病因进行评估并采取适当治疗。如果未查出脑膜炎的其他明确病因，则应考虑停用Lamictal。
FDA还宣布，就在无菌性脑膜炎病例上报期间已发放逾4600万个Lamictal处方。
