Thirteen Laxative-Related Deaths Prompt FDA Warning on Proper Use

thirteen-laxative-deaths-fleetIn a consumer update issued on January 8th, the Food and Drug Administration (FDA) alerted consumers to possible dangerous side effects associated with the use of over-the-counter sodium phosphate laxatives like Fleet enema products.  The agency said it has received reports of 54 cases of serious side effects, including 13 deaths, one of them a child.

Sodium phosphate laxatives help relieve constipation by drawing water into the bowel, which softens stools and makes them easier to pass, the FDA explains. But these medications may produce dangerous side effects if not used according to the instructions,  if they are used by people with certain health conditions, or those taking certain medications.

Sodium phosphate laxatives are sold in oral and rectal formulas under the brand name Fleet and as store brands and generics. Labels for these laxatives warn that people with kidney disease, dehydration, or heart problems should consult a health care professional before using the product. Only one dose of the laxative should be taken in a day, even if the dose does not result in a bowel movement. The product shouldn’t be used for more than three days, according to the Huffington Post.

The FDA safety alert warns consumers taking these laxatives to watch for signs of dehydration or kidney injury. Dehydration symptoms include dry mouth; thirst; reduced urine output; and lightheadedness, especially with changes in position. The user should consult a health care professional if a rectal dose of a laxative is retained in the body longer than 30 minutes. Symptoms of kidney injury include drowsiness; sluggishness; a decreased amount of urine; or swelling of the ankles, feet and legs. Users should seek immediate medical attention for any of these symptoms.

According to Dr. Mona Khurana, a medical officer in the FDA’s Division of Nonprescription Regulation Development, laxative users should carefully follow dose instructions on the Drug Facts label and should not take the product more often or in greater amounts than the label indicates. Caregivers should never give these products to children younger than age 5 without the advice of a health care professional, the Huffington Post reports.

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