The U.S. Food and Drug Administration (FDA) has recently released a warning to its consumers over inappropriate use of over-the-counter (OTC) laxatives. The agency sought to explain the adverse consequences that can befall consumers when failing to adhere to the dosing instructions and warnings printed on the Drug Facts label, or when patients have specific coexisting medical conditions.
The FDA identified serious medical complications in a number of individuals taking sodium phosphate laxatives, using information from a recent review. Sodium phosphate laxatives have been attributed to a slew of reports of serious side effects and 13 fatalities, including a child and 12 adults.
Sodium phosphate is a hydrating agent that works through exerting an osmotic effect in the intestines. Water is osmotically drawn into the gastrointestinal tract, helping to boost the volume within the intestines, thereby increasing the transit rate of fecal matter. The water also ensures the stool becomes softened and is easier to pass during a bowel movement. Essentially, sodium phosphate laxatives work in comparable fashion to bulk fiber preparations.
Laxative products that are known to possess sodium phosphates include store brands and generic products; they are also marketed under the “Fleet” brand name. Use of sodium phosphate laxative products can potentially lead to dehydration, electrolyte imbalance in the bloodstream and more serious medical complications, including kidney damage and death.
The OTC drug label for sodium phosphate laxatives specifically states that only a single dose be administered, once a day, for no longer than three days. Furthermore, those individuals who do not have a bowel movement after orally or rectally administering a dose of a laxative product should not continue treatment.
The product labeling also offers warning to those patients with certain medical conditions that are in need of constipation relief; patients suffering with dehydration, heart problems and kidney disease are all advised to seek appropriate medical advice from trained healthcare professionals, before considering use of laxatives.
However, the FDA has recently discussed additional contraindications associated with certain patients and laxatives, that are not currently highlighted in the Drug Facts label. The agency recommends those individuals over the age of 55, or children and adults with inflammation of the colon, discuss the use of laxatives with a healthcare professional. Likewise, those individuals taking particular medicines should also seek such advice, including patients on the following:
- Diuretics and fluid medicines
- Angiotensin-converting enzyme (ACE) inhibitors
- Angiotensin receptor blockers (ARBs)
- Nonsteroidal anti-inflammatory drugs (NSAIDs), including ibuprofen, naproxen etc.
FDA pediatric nephrologist, Mona Khurana, who operates in the Division of Nonprescription Regulation Development, explained that reports of serious harm were typically associated with patients administering a single dose that exceeded recommendations on the drug label, or those taking multiple daily doses, due to the sodium phosphate laxative offering little initial relief.
Khurana explains that the OTC laxative is safe for use in adults and older children that follow the dosing instructions and are otherwise healthy. She also explains that caregivers should not administer these products orally to children under five, unless they have been instructed to do so by a healthcare professional. In addition, rectal use of these drug products should be avoided by caregivers for children under two years of age.
Consumers are warned to look out for warning signs that signal a bad reaction. Dehydration, for example, is characterized by a dry mouth, increased thirst, dizziness and reduced urine output. In addition, signs of impaired kidney function include drowsiness, decreased urine output and swelling around the legs and feet. Those individuals experiencing adverse reactions are instructed to seek medical assistance, immediately.
By James Fenner