The FDA issued a safety warning to the public on January 9, 2014 addressing the safety concerns they have regarding over-the-counter sodium phosphate drugs, which are used to treat constipation. According to the FDA website, using more than one directional dosage of these medications over the course of 24-hours, can lead to serious health risks including harm to the heart and kidneys, and could even lead to death. Taking a higher dose than the recommended amount may produce the same results, even if taken once a day.
In addition, the FDA safety communication advises caregivers that oral sodium phosphate drugs are not suitable for children ages 5 or under, unless approved by a healthcare professional. The communication also advised healthcare professionals to proceed with caution and consider all risks when prescribing or recommending such drugs for children under the age of 5. The FDA advised that the use of rectally introduced sodium phosphate drugs should not be used for children under the age of 2.
According to the FDA, the administration was prompted to issue the warning on their website due to previous reports of severe dehydration and unintentional changes the drug caused to serum electrolytes, which occurred when the drug was taken more than once in a 24-hour period. The affected serum electrolytes include calcium, sodium, and phosphate.
In addition, individuals over the age of 55 are at risk of developing adverse effects to the drugs. Individuals who are dehydrated or experiencing symptoms of dehydration are not advised to use the drug along with those suffering from kidney disease, bowel obstruction or inflammation.
Finally, anyone taking medications that may affect kidney function are also advised to refrain from using over-the-counter sodium phosphate drugs. These medications include diuretics, water pills, ACE inhibitors, angiotensin receptor blockers and non-steroidal anti-inflammatory drugs like aspirin, ibuprofen, and naproxen.