藥物警訊

Bo Ying Compound by Eu Yan Sang （Hong Kong） Ltd: FDA/CDER Statement - Risk of Lead Poisoning

AUDIENCE: Consumer, Health Professional, Pediatrics, Family Practice

ISSUE: FDA warns parents and caregivers not to use “Bo Ying compound” manufactured by Eu Yan Sang (Hong Kong) Ltd. due to the potential lead poisoning risk associated with the product.

FDA learned of this risk from the New York City Department of Health & Mental Hygiene after the product was tested and found to contain high levels of lead. FDA has received one adverse event report of lead poisoning in an 18-month-old child who was given this product. See the FDA/CDER Statement for product photos.

Exposure to lead can cause serious damage to the central nervous system, the kidneys, and the immune system. In children, chronic exposure to lead, even at low levels, is associated with impaired cognitive function, including reduced IQ, behavioral difficulties, and other problems.

BACKGROUND: The powdered product is marketed in retail outlets and online for use in infants and children for treatment of a variety of conditions including influenza, fever, sneezing, and nasal discharge. The product is labeled in Chinese and English.

RECOMMENDATION: Parents and caregivers are advised to not purchase or use this product. Anyone using this product or providing it to a child should immediately consult a health care professional.

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

FDA發布藥品安全警訊，香港余仁生所生產之產品「保嬰丹」具有鉛中毒之風險，請家長或照顧者注意勿購買此藥給兒童服用。

此產品經紐約市健康與心理衛生機關檢驗出含有高含量的鉛，FDA並接獲一件18個月大幼兒因服用此藥後產生鉛中毒之副作用報告。

FDA表示，鉛中毒可能會導致中樞神經系統、腎臟和免疫系統之嚴重損害；兒童若長期服用含鉛藥品，即使含量很低，也可能會產生認知障礙，如智力降低、行為障礙等問題。

背景

此藥品在許多零售店面和網路皆有販售，宣稱可用於治療嬰幼兒之流感、發燒、打噴嚏和流鼻涕等症狀。

建議

FDA建議家長或照顧者勿購買或服用此產品。若有兒童已服用此藥，請立即就醫。

相關訊息與連結請參考FDA網址： http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHuma...

Xolair (omalizumab): Drug Safety Communication - Slightly Elevated Risk of Cardiovascular and Cerebrovascular Serious Adverse Events

AUDIENCE: Allergy and Immunology, Pharmacy, Health Professional

ISSUE: An FDA review of safety studies suggests a slightly increased risk of problems involving the heart and blood vessels supplying the brain among patients being treated with the asthma drug Xolair (omalizumab) than in those who were not treated with Xolair. As a result, FDA has added information about these potential risks to the drug label.

The review found no difference in the rates of cancer between those patients being treated with Xolair and those who were not being treated with Xolair. However, due to limitations in the 5-year study, FDA cannot rule out a potential risk of cancer with Xolair, so this information was added to the Warnings and Precautions section of the drug label.

BACKGROUND: Xolair is an injectable medicine for patients 12 years of age and older with moderate to severe persistent allergic asthma whose asthma symptoms are not controlled by asthma medicines called inhaled corticosteroids.

RECOMMENDATION: Patients taking Xolair should continue to take the medication as prescribed and discuss any questions or concerns with their health care professionals.

Read the MedWatch safety alert, including links to the Drug Safety Communication at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHuma...

依據一項藥品安全性回顧研究，FDA認為使用氣喘藥品Xolair (omalizumab)可能會稍微增加病人心血管及腦血管相關疾病之風險。FDA已將此風險加註於藥品仿單。

此回顧發現使用Xolair (omalizumab)與否，其罹癌比率並無顯著差異，但此研究受限於5年的時間限制，FDA並無完全排除Xolair (omalizumab)致癌之潛在風險，故此資訊也將列入藥品仿單之警語與注意事項中。

背景

Xolair (omalizumab)為注射劑藥品，適用於12歲以上因使用吸入性類固醇無法有效控制之中重度持續過敏性氣喘病人。

建議

正在使用此藥之病人應繼續按醫囑服用，請勿自行停藥，若有任何問題請與醫療人員聯絡。

相關訊息與連結請參考FDA網址：http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm416408.htm

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