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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.
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.
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.
