Limit use of sodium phosphate to treat constipation, FDA warns

More than one dose of over-the-counter sodium phosphate to treat constipation in a 24-hour period may lead to kidney or heart damage or death in rare cases, the FDA warned.

“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,” the release said.

“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.”

The products come as oral solutions or as enemas, and the administration reminded consumers and health care professionals to read the drug fact labels and not exceed recommended dosages. In particular, the FDA reminded caregivers to never give the oral product to children aged 5 years or younger without speaking to a health care professional, and that the rectal form of the drug should not be given to children aged younger than 2 years.

At potentially higher risk for adverse events are young children, people aged older than 55 years and patients with dehydration, kidney disease, bowel obstruction or inflammation of the bowel, the release said. Also at potentially higher risk are patients using medications that may affect kidney function, including diuretics or water pills, angiotensin converting enzyme inhibitors, angiotensin receptor blockers used to treat high blood pressure and nonsteroidal anti-inflammatory drugs.