便秘药物过量可导致心脏和肾脏疾病

美国食品药品管理局(FDA)近日宣布，超过推荐剂量的非处方药磷酸钠盐药物可导致严重肾脏和心脏疾病。

FDA声明指出，这类经常被用于缓解便秘的药物与脱水、电解质水平改变以及更为严重的并发症相关，包括肾脏损伤、心律失常和死亡。

通过分析FDA不良事件报告系统和医学文献数据，确认了1957~2013年共计发生54例与磷酸钠盐药物相关的不良事件，其中成人25例，儿童29例。在这些病例中，既有直肠给药患者，也有口服给药患者。儿童病例中属于严重不良事件者占60%(16例)，成人为70%(16例)，1例儿童和12例成人死亡。

据报告，严重损害病例多为单次给药超过推荐剂量或每天用药次数超过1次的患者。该药物推荐用法为1次/天且不超过3天。

虽然不良反应罕见，但FDA仍建议在开具这类药物时应慎重。少儿、55岁以上患者以及肾病史患者的潜在不良事件风险增加。

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By: MIKE BOCK, Internal Medicine News Digital Network

Exceeding the recommended dosage of over-the-counter sodium phosphate drugs can lead to severe kidney and heart problems, the Food and Drug Administration has announced.

The drugs, which are often prescribed for constipation relief, have been linked to dehydration, changes in electrolyte levels, and more severe complications, including kidney injury, arrhythmias, and death, the agency said in a statement.

A review of data from the FDA’s Adverse Event Reporting System and the medical literature identified 54 cases of adverse events from sodium phosphate drugs, with 25 adults and 29 children affected between 1957 and 2013. Of those cases, which included both rectal and oral administration of the drugs, adverse events deemed serious occurred in 60% (16) of the pediatric cases and 70% (16) of the adult cases, and resulted in the death of one child and twelve adults.

According to the reports, most cases of serious harm occurred with a single dose that was larger than recommended or with more than one dose per day. The recommended dosage is one dose per day for a maximum of 3 days.

While adverse effects are rare, the FDA recommends caution in prescribing the drugs. Young children, patients over 55 years, and people with a history of kidney problems are at an increased risk of potential adverse events.