藥物警訊

Sodium Phosphate Over-the-Counter Products: Drug Safety Communication - Possible Harm From Exceeding Recommended Dose

Marketed under the brand-name Fleet, and as store brands and generic products.

AUDIENCE: Consumer, Family Practice

ISSUE: FDA is warning that using more than one dose in 24 hours of over-the-counter (OTC) sodium phosphate drugs to treat constipation can cause rare but serious harm to the kidneys and heart, and even death.

FDA has become aware of reports of severe dehydration and changes in the levels of serum electrolytes from taking more than the recommended dose of OTC sodium phosphate products, resulting in serious adverse effects on organs, such as the kidneys and heart, and in some cases resulting in death. These serum electrolytes include calcium, sodium, and phosphate. According to the reports, most cases of serious harm occurred with a single dose of sodium phosphate that was larger than recommended or with more than one dose in a day.

For additional clinical information, see the FDA Drug Safety Communication Data Summary.

BACKGROUND: OTC sodium phosphate drug products include oral solutions taken by mouth and enemas used rectally. Marketed under the brand-name Fleet, and as store brands and generic products. Available as single-ingredient drug products, containing either sodium biphosphate or sodium phosphate, and as combination drug products containing both ingredients.

RECOMMENDATION: Consumers and health care professionals should always read the Drug Facts label for OTC sodium phosphate drugs and use these products as recommended on the label, and not exceed the labeled dose. Caregivers should not give the oral products to children 5 years and younger without first discussing with a health care professional. Health care professionals should use caution when recommending an oral dose of these products for children 5 years and younger. The rectal form of these products should never be given to children younger than 2 years.

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

FDA提醒大眾，治療便秘的非處方藥品磷酸鈉 (sodium phosphate)，若一天內使用一次以上，可能會發生嚴重副作用，甚至死亡。FDA已接獲因服用超過建議劑量的藥品後出現嚴重脫水和血中電解質如鈣離子、鈉離子和磷離子之濃度異常，進而導致如腎臟、心臟等器官受損甚至死亡的案例報告。依據報告，大多數案例為一次服用超過建議的劑量，或一天內服用一次以上。

背景

非處方藥品sodium phosphate 包含口服溶液和灌腸液。產品分別有單一成分如磷酸二氫鈉 (sodium biphosphate)或磷酸鈉 (sodium phosphate)和含有以上兩種成分的複方藥品。

建議

FDA建議消費者及醫療人員應遵照仿單指示使用藥品，不要服用超過仿單上建議的劑量。未經醫療人員審慎評估及指示，請勿自行讓五歲以下兒童服用該口服溶液，且兩歲以下兒童也不建議使用灌腸液。

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