FDA public health advisories

FDA: Excess doses of sodium phosphate can harm heart, kidneys

The FDA has issued a safety communication warning that using more than one dose in 24 hours of over-the-counter sodium phosphate drugs for constipation can harm the heart and kidneys, and could even lead to death.

The agency advised caregivers not to give oral sodium phosphate drugs to children aged 5 years and younger without consulting with a health care professional, and advised health care professionals to use caution when considering sodium phosphate drugs for that population. It also stated that rectal sodium phosphate drugs should not be given to children younger than 2 years of age.

The FDA issued the statement after receiving reports of severe dehydration and changes in levels of serum electrolytes after taking excess doses of sodium phosphate drugs, resulting in serious adverse events on the heart and kidneys and sometimes resulting in death. In most cases of serious harm, those affected received a single dose that was larger than recommended, or received more than one dose in a day.

The agency stated that the following groups are at high risk for adverse events after excess dosing of sodium phosphate: young children; individuals older than 55 years; those who are dehydrated; those who have kidney disease, bowel obstruction or inflammation of the bowel; and those taking medications that may affect kidney function. Such medications include diuretics, water pills, ACE inhibitors, angiotensin receptor blockers and non-steroidal anti-inflammatory drugs including aspirin, ibuprofen and naproxen.

The FDA has issued a safety communication warning that using more than one dose in 24 hours of over-the-counter sodium phosphate drugs for constipation can harm the heart and kidneys, and could even lead to death.

The agency advised caregivers not to give oral sodium phosphate drugs to children aged 5 years and younger without consulting with a health care professional, and advised health care professionals to use caution when considering sodium phosphate drugs for that population. It also stated that rectal sodium phosphate drugs should not be given to children younger than 2 years of age.

The FDA issued the statement after receiving reports of severe dehydration and changes in levels of serum electrolytes after taking excess doses of sodium phosphate drugs, resulting in serious adverse events on the heart and kidneys and sometimes resulting in death. In most cases of serious harm, those affected received a single dose that was larger than recommended, or received more than one dose in a day.

The agency stated that the following groups are at high risk for adverse events after excess dosing of sodium phosphate: young children; individuals older than 55 years; those who are dehydrated; those who have kidney disease, bowel obstruction or inflammation of the bowel; and those taking medications that may affect kidney function. Such medications include diuretics, water pills, ACE inhibitors, angiotensin receptor blockers and non-steroidal anti-inflammatory drugs including aspirin, ibuprofen and naproxen.