FDA发布关于Maalox产品的警告

ST LOUIS (MD Consult) - On February 17, 2010, the US Food and Drug Administration (FDA) issued a warning about the potential for the occurrence of serious adverse effects if the product Maalox Total Relief is mistakenly taken instead of other Maalox products. The products are not interchangeable.

Maalox Total Relief, which contains bismuth subsalicylate, is used for the treatment of stomach upset and diarrhea, whereas the traditional Maalox liquid products Maalox Advanced Regular Strength and Maalox Advanced Maximum Strength are considered antacids. Bismuth subsalicylate is chemically related to aspirin and may cause similar harmful adverse effects (eg, bleeding).

Persons with bleeding disorders and persons with a history of gastrointestinal ulcers should not ingest Maalox Total Relief. The medication also should not be given to children and teenagers during recovery from viral infections, nor to persons who are being treated with certain medications including oral antidiabetic agents, anticoagulants (eg, warfarin and clopidogrel), and anti-inflammatory drugs.

The packaging and labeling of Maalox Total Relief and traditional Maalox Advanced Regular Strength and Maalox Advanced Maximum Strength are very similar and easily confused. The maker of Maalox-brand products has agreed to change the name of Maalox Total Relief to one that does not include the word "Maalox" and will change the drug's packaging to avoid further confusion. The renamed product is expected to begin selling in September 2010. Until that time, the FDA is advising consumers and health care professionals to carefully check the labels of all Maalox products to ensure appropriate product selection.

圣路易斯(MD Consult)——2010年2月17日，美国食品药品管理局(FDA)发布警告，称如果将Maalox Total Relief误认为其他Maalox产品而服用，则可能导致出现严重不良反应。这些产品并不能互换。

Maalox Total Relief含有次水杨酸铋，适用于治疗胃部不适和腹泻，而传统Maalox液体产品Maalox Advanced Regular Strength和Maalox Advanced Maximum Strength则属于抗酸剂。 次水杨酸铋与阿司匹林的化学结构相似，并且两者引起的不良反应也相似(如出血)。

下列患者不应服用Maalox Total Relief：出血障碍患者、具有胃肠道溃疡病史的患者、处于病毒感染恢复期的儿童和青少年，以及正接受口服抗糖尿病药、抗凝剂(如华法林和氯吡格雷)和抗炎药等特定药物治疗的患者。

Maalox Total Relief与传统Maalox Advanced Regular Strength和Maalox Advanced Maximum Strength的包装和标签非常相似，因此较易混淆。Maalox牌产品的生产商已同意变更Maalox Total Relief的名称(新名称将不包含“Maalox”字眼)，并变更其包装，以避免进一步混淆。该药在更名妥当后，预计可于2010年9月开始上市。FDA建议消费者和医学专业人员仔细检查所有Maalox产品的标签，以确保所选产品无误。