FDA Warns Users of OTC Laxatives About Serious Health Risks

The U.S. Food and Drug Administration (FDA) is warning that using more than one dose in a 24 hour period of over-the-counter (OTC) sodium phosphate drugs to treat constipation can cause rare, but serious harm to the kidneys and heart and can even result in death. OTC sodium phosphate drug products include the oral solutions (taken by mouth) and enemas (used rectally).

Laxatives with sodium phosphates are marketed under the brand name “Fleet” and also as store brands and generic products. All of them can cause serious side effects if used improperly. These side effects include severe dehydration and changes in the levels of serum electrolytes from taking more than the recommended dose of OTC sodium phosphate products, resulting in serious adverse effects on organs, such as the kidneys and heart, and in some cases, death.

The serum electrolytes include calcium, sodium, and phosphate. According to the reports, most cases of serious harm occurred with a single dose of sodium phosphate that was larger than the recommended dose or with more than one dose in a day.

The agency said there have been dozens of reports of serious side effects, including 13 deaths, among people taking sodium phosphate laxatives, which are sold over-the-counter.

Some individuals may be at higher risk for potential adverse events when the recommended dose of OTC sodium phosphate is exceeded. These individuals include young children; individuals over the age of 55; patients who are dehydrated; patients with kidney disease, bowel obstruction, or inflammation of the bowel; and patients who are using medications that may affect kidney function. These medications include diuretics (or water pills); angiotensin- converting enzyme inhibitors (ACEIs) and angiotensin receptor blockers (ARBs) used to treat high blood pressure; and non-steroidal anti-inflammatory drugs (NSAIDs) such as aspirin, ibuprofen and naproxen.

The labels on these products state that they should be used as a single dose taken once a day; should not be used for more than three days, and that patients who are dehydrated or have kidney disease or heart problems should consult with a health care professional before taking these laxatives.

In recent reviews, the FDA has identified 54 cases of serious side effects associated with the oral or rectal use of sodium phosphate laxatives in adults or children. Twelve adults and one child died.

Contact one of our Gacovino Lake attorneys at 1-800-246-HURT (4878) for more information.

Related Posts