藥物警訊

Over-the-Counter Asthma Products Labeled as Homeopathic: FDA Statement - Consumer Warning About Potential Health Risks

AUDIENCE: Consumer, Pharmacy, Health Professional

ISSUE: FDA is warning consumers not to rely on asthma products labeled as homeopathic that are sold over-the-counter (OTC). These products have not been evaluated by the FDA for safety and effectiveness.

Asthma is a serious, chronic lung condition. If asthma is not appropriately treated and managed, patients may have wheezing, shortness of breath, and coughing, and could be at risk for life-threatening asthma attacks that may require emergency care or hospitalization. Although there is no cure for asthma, there are many prescription asthma treatments approved by FDA as safe and effective, as well as some products that are marketed OTC in accordance with an FDA monograph.

BACKGROUND: OTC asthma products labeled as homeopathic are widely distributed through retail stores and via the internet. Many of these products are promoted as “natural,” “safe and effective,” and include indications that range from treatment for acute asthma symptoms, to temporary relief of minor asthma symptoms. In general, consumers can identify such products by looking for the word “HOMEOPATHIC” or “HOM?OPATHIC” on a product's label and looking for whether the product's active ingredient(s) are listed in terms of dilution (e.g., “LM1” "6X" or "30C").

RECOMMENDATION: Speak to your health care provider if you think you or your child may have asthma. Consumers with asthma can take an active role in managing their condition by making certain they have appropriate treatments on hand in the event they experience an asthma attack or a worsening of asthma symptoms, and by consulting with a health care provider when needed.

Read the MedWatch Safety Alert, including links to the FDA Statement, at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHuma...

FDA提醒氣喘病人勿僅依賴使用坊間販售之順勢療法藥品，此類藥品並未經過FDA審核及認可其安全性及療效。

氣喘為嚴重且慢性之肺部疾病。若無適當的治療與處置，病人可能發生呼吸急促、咳嗽、嚴重時危及生命之氣喘發作，需緊急送醫或住院治療。雖然氣喘無法治癒，但目前有許多經FDA認可安全且有效的氣喘用藥，以及部分符合FDA認定標準之非處方藥。

標示為順勢療法的氣喘用藥已廣泛於零售店或網路販售。許多產品稱之為「天然」且「安全有效」，其適應症範圍廣泛，可治療急性氣喘甚至暫時緩解輕微氣喘症狀。順勢療法藥品通常可透過產品上之“HOMEOPATHIC”或“HOM?OPATHIC”文字以及主要成分得知。

氣喘可藉由積極治療緩解急性發作或惡化。病人若認為自己或孩童可能患有氣喘，必要時應諮詢醫療人員或就醫。

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