托吡酯获准用于青少年偏头痛预防

据美国食品药品管理局(FDA)发布的声明，托吡酯已成为首个获准用于青少年偏头痛预防的药物。

托吡酯(妥泰)最初于1996年获准用于预防癫痫症，2004年获准用于预防成人偏头痛。该新批准令将每日100 mg托吡酯的适应症扩大至12岁青少年偏头痛预防。

该批准令是基于一项纳入103例12~17岁青少年的临床试验结果。托吡酯受试者偏头痛频次减少72%，而安慰剂组减少44%。FDA药品评价与研究中心神经产品部副主任Eric Bastings博士称：“该药物处方信息中添加青少年人群剂量和安全信息，将有助于医疗专业人员和患者做出治疗选择。”

服用批准剂量托吡酯最常见不良反应为感觉异常、上呼吸道感染、厌食和腹部疼痛。

托吡酯以及所有抗癫痫药物可增加自杀意念和行为风险。应建议患者警惕抑郁症状的出现或恶化以及情绪或行为的异常变化。

FDA声明指出，已表明孕期女性服用托吡酯可增加后代唇腭裂风险。如果育龄女性决定服用该药物，应采取有效避孕措施。

妥泰由杨森制药公司生产。

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By: MARY JO M. DALES, Clinical Neurology News Digital Network

Topiramate has become the first drug to be approved for migraine prevention in adolescents, according to a release from the Food and Drug Administration.

First approved in 1996 to prevent seizures, topiramate (Topamax) was approved in 2004 for migraine prevention in adults. The new approval extends daily use of topiramate at 100 mg for migraine prophylaxis to adolescents as young as 12 years old.

"Adding dosing and safety information for the adolescent age group to the drug’s prescribing information will help to inform health care professionals and patients in making treatment choices," said Dr. Eric Bastings, deputy director of the division of neurology products in the FDA’s Center for Drug Evaluation and Research.

The approval was based on the results of a clinical trial of 103 adolescents aged 12-17 years. Those on topiramate had a 72% reduction in the frequency of migraines; those treated with placebo had a 44% reduction.

The most common adverse reactions with the approved dose were paresthesia, upper respiratory infection, anorexia, and abdominal pain.

Topiramate and all antiepileptic drugs may increase the risk of suicidal thoughts and behavior. Patients should be advised to be alert for the emergence or worsening of symptoms of depression and unusual changes in mood or behavior.

In women who take the drug during pregnancy, topiramate has been shown to increase the risk in offspring of cleft lip and palate. If the decision is made to use the medication by a woman of childbearing age, effective birth control should be used, the agency said in a release.

Topamax is manufactured by Janssen Pharmaceuticals.