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January 13, 2014
On Jan. 8, 2014, the Food and Drug Administration (FDA) issued an alert to patients and health care providers warning about serious, and even fatal, kidney and heart risks from exceeding the recommended dose of over-the counter (OTC) sodium phosphate products used to treat constipation.
Sodium phosphate laxatives are sold under the brand name FLEET or as store or generic products. These OTC products come both as oral solutions (taken by mouth) and enemas (taken...
January 13, 2014
On Jan. 8, 2014, the Food and Drug Administration (FDA) issued an alert to patients and health care providers warning about serious, and even fatal, kidney and heart risks from exceeding the recommended dose of over-the counter (OTC) sodium phosphate products used to treat constipation.
Sodium phosphate laxatives are sold under the brand name FLEET or as store or generic products. These OTC products come both as oral solutions (taken by mouth) and enemas (taken rectally). It is important that patients read the labels and follow the instructions exactly, since most serious reports of harm came from people inadvertently taking a dose higher than recommended, either as one higher dose or more than one dose in a single day.
Overdosing on these products can lead to severe dehydration and blood electrolyte abnormalities (predominantly high blood phosphate and sodium levels and low calcium levels) which can cause serious complications such as acute kidney failure, abnormal heart rhythms and death.
It is particularly important that caretakers not give the oral form of sodium phosphate to children 5 years and younger without consulting a health care professional. The rectal form of these drugs should never be given to children younger than 2 years.
People who are at greatest risk for serious harm from taking more than the recommended dose of sodium phosphate products include:
- Children younger than age 5
- Adults older than 55 years
- Individuals who are dehydrated
- Patients with kidney disease, heart failure, or bowel obstruction or inflammation
- Patients taking medicines that can affect kidney function, including diuretics, angiotensin-converting enzyme inhibitors, angiotensin receptor blockers, and non-steroidal anti-inflammatory drugs.
The FDA issued a warning in 2008 about the risk of kidney injury with the use of higher doses of oral sodium phosphate products for bowel cleansing prior to colonoscopy.
What You Can Do
If you have any of the risk factors listed above, talk to your primary health care provider before using any OTC sodium phosphate product.
You should never take more than one dose of these products in 24 hours.
Do not give the oral form of sodium phosphate to children 5 years and younger without consulting your child’s pediatrician.
Never give the rectal form of these drugs to children younger than age 2.
You should seek immediate medical attention if you or your child experiences any symptoms of kidney failure after using a sodium phosphate product, such as nausea; vomiting; loss of appetite; drowsiness; sluggishness; decreased urine; or swelling of ankles, feet or legs.
Read the complete safety alert for 2014:
http://www.fda.gov/Drugs/DrugSafety/ucm380757.htm
Read the complete safety alert for 2008:
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/2008/ucm116988.htm
Report any adverse effects related to OTC sodium phosphate products to the FDA MedWatch program.
