FDA Says There Have Been 13 Laxative-Related Deaths

01/08/2014 03:48 pm ET | Updated Jan 25, 2014
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Fifty-four cases of serious side effects -- including 13 deaths -- have been associated with oral and rectal use of sodium phosphate laxatives, according to a new warning from the Food and Drug Administration on improper use of the products.

The FDA issued the warning today (Jan. 8), explaining that this kind of over-the-counter laxative -- used to combat constipation by softening the stools to promote bowel movements -- could carry dangerous side effects if not taken according to the instructions, or if they're taken by people with certain health conditions. Sodium phosphate laxatives are a type of saline laxative, and are often marketed under the brand name "Fleet" or as a generic.

Therefore, all adults older than age 55, as well as adults and children with some health conditions, should talk to a doctor or health care professional before taking this kind of laxative. The FDA notes that people should talk to a doctor before taking these laxatives if they have colon inflammation, or they take kidney medications (such as diuretics), ACE inhibitors, angiotensin receptor blockers, NSAIDs or ibuprofen.

In addition, children younger than age 5 should not take these laxatives without prior consultation with a health care professional, the warning said.

Right now, labels for these laxatives carry warnings that people with kidney disease, dehydration or heart problems should talk to a health care professional before use of the product. In addition, only one dose of the laxative should be taken a day, and the product shouldn't be used for more than three days. People should not take more than one dose of the laxative a day, even if they don't experience a bowel movement after taking it.

Dr. Mona Khurana, M.D., a medical officer in the Division of Nonprescription Regulation Development at the FDA, explained in the warning that most cases of serious side effects associated with the laxatives are due to people taking a higher dose in a day than was indicated on the product label, or if they took more than one dose in one day.

"The bottom line is that these products are safe for otherwise healthy adults and older children for whom dosing instructions are provided on the Drug Facts label as long as they follow these dosing instructions and don't take the product more often, or in greater amounts, than the label instructs," Khurana said in the warning.

How can you tell if you're having an adverse reaction to this laxative? The FDA explains:

Consumers taking these laxatives should watch for warning signs of a bad reaction. For example, a rectal dose that is retained and does not produce a bowel movement may cause dehydration and/or serious changes in blood electrolyte levels. Symptoms of dehydration include dry mouth, thirst, reduced urine output, and lightheadedness, especially with changes in position. If the rectal dose is retained in the body longer than 30 minutes, a health care professional should be contacted right away.

The symptoms of kidney injury include drowsiness, sluggishness, a decreased amount of urine, or swelling of the ankles, feet and legs. If you experience any of these symptoms after using laxatives containing sodium phosphates, you should seek medical attention immediately.

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