藥物警訊

Unapproved Prescription Ear Drop (Otic) Products: Not FDA Evaluated for Safety, Effectiveness and Quality

AUDIENCE: Family Practice, Consumer, Pediatrics

ISSUE: FDA announced its intention to take enforcement action against companies that manufacture and/or distribute certain unapproved prescription ear drop products (known as otic products) labeled to relieve ear pain, infection, and inflammation. The unapproved prescription ear drops contain active ingredients such as benzocaine and hydrocortisone, and have not been evaluated by the FDA for safety, effectiveness and quality. The labels on these products do not disclose that they lack FDA approval, and health care professionals may not be aware of their unapproved status.

Unapproved prescription otic drug products are frequently given to young children suffering from ear infections and other conditions that cause ear pain and swelling. Patients taking unapproved drugs may be at greater risk because there is no proven safety or effectiveness information. These products may be contaminated or manufactured incorrectly, which could result in patients receiving the wrong dose, even when administered according to the labeled directions for use.

Unapproved prescription otic drug products containing the following ingredients are covered by this action:

‧ benzocaine;
‧ benzocaine and antipyrine;
‧ benzocaine, antipyrine, and zinc acetate;
‧ benzocaine, chloroxylenol, and hydrocortisone;
‧ chloroxylenol and pramoxine; and
‧ chloroxylenol, pramoxine, and hydrocortisone.

BACKGROUND: FDA informed the companies that they must stop manufacturing these unapproved prescription otic products or be subject to enforcement actions, including seizure, injunction and/or criminal proceedings. Today's action does not affect FDA-approved prescription otic products, or legally marketed otic products sold over-the-counter.

RECOMMENDATION: Consumers who believe they are using unapproved prescription ear drops should contact their health care provider to discuss alternatives.

Read the MedWatch safety alert, including a link to the FDA news release, at:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHuma...

美國FDA公告將對製造及販售未經核准之耳滴劑之藥品公司採取強制法律行動。此類藥品為用於緩解耳朵痛、感染和發炎症狀之耳滴劑，常用於孩童。其有效成份如benzocaine及hydrocortisone等，安全性、療效及品質並未經美國FDA評估認證，且包裝上沒有標示「未經FDA許可」，醫療人員可能在未知情況下使用此藥。

此類違法藥品缺乏產品安全性及療效資訊，且可能遭汙染或製程不正確，病人用藥將暴露於風險之中。

此類單/複方耳滴劑可能含有以下成份：

1. Benzocaine
2. Benzocaine和antipyrine
3. Benzocaine, antipyrine和zinc acetate
4. Benzocaine, chloroxylenol和hydrocortisone
5. Chloroxylenol和pramoxine
6. Chloroxylenol, pramoxine和hydrocortisone

美國FDA已通知藥廠停止製造這些違法藥品，否則將受到法律制裁，也提醒民眾若正在使用上述藥品應與醫師討論更換用藥。

相關訊息與連結請參考FDA網址：

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHuma...

資料來源：美國FDA之藥物安全警訊
資料提供：台大醫院藥劑部