FDA Warns of Dangers associated with Excessive Use of Laxative Products
On January 8, 2014, the FDA issued a Safety Announcement “warning that using more than one dose in 24 hours of over-the-counter sodium phosphate drugs to treat constipation can cause rare but serious harm to the kidneys and heart, and even death.”
The sodium phosphate drug products at issue are marketed under the brand-name Fleet, and as store brands and generic products. They are used for the relief of occasional constipation and are available for either oral or rectal (enema) use.
The FDA issued this warning based on several reports of severe dehydration and changes in the levels of serum electrolytes that people experienced after taking these products too often or in higher-than-recommended doses, which resulted in adverse effects on vital organs – and even causing death. The FDA also provided health care professionals with additional information, including but not limited to, the following:
- The rectal forms of laxatives should not be considered safer than the oral forms of laxatives;
- Additional laxative doses are not recommended within 24 hours for patients who do not have a bowel movement after taking an oral or rectal dose;
- Patients should be adequately hydrated during product use;
- Serum electrolytes and renal function should be assessed in patients who may be at a higher risk for adverse events.
According to USA Today, Fleet “fully supports the efforts of the FDA to encourage the safe use of sodium phosphate products” and encourages consumers “to follow the recommended dosing instructions as recommended by the FDA.”
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