FDA Warns Some OTC Laxatives May Cause Serious Side Effects after dozens of reports associated with sodium phosphate laxatives where 13 people have died.
The U.S. Food and Drug Administration (FDA) has issued a safety warning for any consumer who uses over-the-counter (OTC) sodium phosphate laxatives to treat constipation. These types of laxatives, sold under the brand name Fleet, as well as store brands and generic brands, pose serious dangers to the heart and kidneys, and can even cause death, when taken by individuals with certain health conditions or when the dosage instructions are not followed. The FDA has received dozens of serious side effect reports associated with sodium phosphate laxatives, and 13 people have died.
The FDA said that reports of changes in serum electrolyte levels and severe dehydration can occur when more than the recommended dosage of sodium phosphate laxatives is taken, which can have serious effects on internal organs, including the heart and kidneys, and can result in death in some cases. The FDA reports that most of the cases of serious side effects occurred when a consumer either used a larger than recommended single dose, or used more than one dose in a day. (http://www.fda.gov/Drugs/DrugSafety/ucm380757.htm)
According to the label of sodium phosphate laxatives, the product should be taken once a day as a single dose, and should not be used for more than three days. The label also says that consumers should speak to their healthcare professionals before using these laxatives if they, or their children, have heart problems, kidney disease, or dehydration.
FDA Issues New Laxative Warning
The agency is now warning adults over the age of 55 and children and adults who –
• Have inflammation of the colon
• take diuretics or fluid medicines that may affect how the kidneys work
• use angiotensin-converting enzyme (ACE) inhibitors to lower blood pressure
• use angiotensin receptor blockers (ARBs) to treat high blood pressure, or kidney or heart failure
• use non-steroid anti-inflammatory drugs (NSAIDs) such as ibuprofen
should speak to their healthcare professionals prior to using sodium phosphate laxatives, as these people could be at a higher risk of serious side effects. (http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm379440.htm)
Dr. Mona Khurana, a medical officer in the FDA’s Division of Nonprescription Regulation Development said “The bottom line is that these products are safe for otherwise healthy adults and older children for whom dosing instructions are provided on the Drug Facts label as long as they follow these dosing instructions and don’t take the product more often, or in greater amounts, than the label instructs.” Khurana also said in the FDA Consumer Update that “Caregivers should not give these products orally to children under age 5 years without first asking a health care professional. Both caregivers and health care professionals should avoid the rectal use of these drug products in children under age 2 years,” Khurana cautions. “These warnings against use in young children are listed on product labeling.”
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