U.S. Food and Drug Administration (FDA) Releases Warning About Sodium Phosphate Laxatives

An announcement from IFFGD recently alerted us to the fact that the U.S. Food and Drug Administration (FDA) recently issued expanded warnings regarding over the counter oral or rectal laxatives that contain sodium phosphate, due to increased risks of severe side effects or death in certain groups of users. Currently, labels state to take a maximum of one dose per day for three days. However, if the first dose is ineffective in relieving constipation, consumers should not continue taking the laxative product.

The updated cautions, which are not yet on product labels, now advise adults over the age of 55, as well as adults with, or caregivers of children with, kidney disease, heart disease, dehydration, colon inflammation or who are taking “diuretics or fluid medicines; angiotensin-converting enzyme (ACE) inhibitors used to lower blood pressure; angiotensin receptor blockers (ARBs) used to treat high blood pressure, heart, or kidney failure; and nonsteroidal anti-inflammatory drugs (NSAIDs), such as ibuprofen”  to consult a physician or other health care professional before using over the counter sodium phosphate-based laxatives. Such products are marketed in the U.S. under the Fleet brand name and other generic or store versions.

This change in FDA advice is the result of its review of 54 cases of serious adverse effects, including dehydration, electrolyte imbalance and kidney damage, which were ultimately fatal for 12 adults and one child in this group. As not all instances of side effects are necessarily reported to the FDA, the press release states that a precise rate of these negative outcomes is not known. For more information, see the links in the first paragraph of this post.

IBS Impact is a grassroots effort by people with IBS that focuses on awareness and advocacy, not treatment.  We do strive to provide information and resources that are  reputable, accurate and balanced to the extent of the current scientific knowledge of experienced professionals in the field of IBS and functional gastrointestinal disorders, and to encourage others with IBS and their families to make fully informed decisions that are right for their own situations. Readers with specific questions about this warning in relation to their own IBS or other condition that causes constipation are encouraged to consult their own doctors and other health care providers.

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