ST LOUIS (MD Consult) - The US Food and Drug Administration (FDA) has approved a new prescription medication for treating head lice infestation (Pediculosis capitis).

Benzyl Alcohol Lotion, 5%, received full market approval as a prescription medication, for use in patients 6 months old and older.

This is the first head lice product approved by the FDA with benzyl alcohol as the active pharmaceutical ingredient.

Head lice affect more than a 1 million children each year and are easily transmitted to others, according to Janet Woodcock, MD, director of the FDA's Center for Drug Evaluation and Research.

"This drug is an effective first line treatment to eliminate lice infestation, and minimize disruption in the daily routines of families," Dr Woodcock said.

The safety and effectiveness of Benzyl Alcohol Lotion, 5%, was demonstrated in 2 studies of 628 people, aged 6 months and older, with active head lice infestation. The subjects received two 10-minute treatments of either Benzyl Alcohol Lotion or a topical placebo, 1 week apart. Fourteen days after the final treatment, more than 75% of the subjects treated with Benzyl Alcohol Lotion, 5%, were lice free.

Common adverse effects of the medication include irritations of the skin, scalp, and eyes, and numbness at the site of application. As with all medications, it is important to use Benzyl Alcohol Lotion, 5%, as labeled to maximize benefits and minimize risks. The product should be applied only to the scalp or the hair attached to the scalp. It is not approved for use in children younger than 6 months. Use in premature infants could lead to serious respiratory problems or heart- or brain-related adverse events, such as seizure, coma, or death.

Benzyl Alcohol Lotion, 5%, is distributed by Sciele Pharma Inc, a subsidiary of Atlanta-based Shionogi Company.
 

圣路易斯(MD Consult)——美国食品和药物管理局(FDA)已经批准了一种新的处方药用于治疗头虱(Pediculosis capitis)侵染。

5%苯甲醇洗剂获得了完全销售许可，用于治疗年龄在6个月以上的头虱患者。

 

这是美国FDA首次批准的以苯甲醇为活性药物成分的头虱药品。

 

美国FDA药物评价和研究中心主任Janet Woodcock博士指出，头虱每年困扰着超过100万儿童，并且容易相互传染。

“该洗剂是有效的头虱一线治疗药物，对家庭日常生活的影响极少。” Woodcock博士说。

5%苯甲醇洗剂的安全性和有效性是通过对两项共计入选628名6个月以上、处与活动期头虱感染患者的临床试验证实的。受试者分2次，间隔一周在患处接受10分钟苯甲醇治疗或局部使用安慰剂，结果在最后一次治疗后14天，5%苯甲醇组有75%的患者头虱被消灭。

该洗剂常见的副作用包括对皮肤、头皮或眼睛的刺激，或在涂用局部有麻木感。重要的是每次使用都要保证最大的收益风险比。该产品只可用于头皮或附于头皮的头发上，未获准用于6个月以下儿童。用于未成熟婴儿会导致严重呼吸系统、心脏以及脑部相关的不良事件如癫痫、昏迷或死亡。

 

5%苯甲醇洗剂由Sciele制药公司分销，该公司为亚特兰大Shionogi公司的一家子公司。