The U.S. Food and Drug Administration (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. OTC sodium phosphate drug products include oral solutions taken by mouth and enemas used rectally. 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
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.
individuals may be at higher risk for potential adverse events when the
recommended dose of
OTC sodium phosphate is exceeded.
include young children; individuals older than 55 years; patients who
are dehydrated; patients with kidney disease, bowel obstruction, or
inflammation of the bowel; and patients who are using medications that
may affect kidney function. These medications include diuretics or water
pills; angiotensin converting enzyme inhibitors (ACEIs) and angiotensin
receptor blockers (ARBs) used to treat high blood pressure; and
nonsteroidal anti-inflammatory drugs (NSAIDs) such as aspirin,
ibuprofen, and naproxen.