Fleet Enema label misleads – it’s not just “saline”


Consumers should also be aware of potential safety issues involving the phosphate content in Fleet enemas. This is especially true in elderly patients, who may use more than just one enema at a time and risk metabolic disorders and fatalities. When a Fleet enema is used, a second dose in quick succession to the first should not be used. Prolonged use or overuse can also lead to dehydration as well as fluid and electrolyte imbalances.

Earlier this year, the Department of Veteran’s Affairs (VA) issued a report about a patient who received multiple phosphate enemas in less than 12 hours. The patient subsequently developed critical electrolyte abnormalities and acute kidney injury and later died.

A concern that pharmacists also have about these products is the way that cartons are labeled. Fleet refers to the product as “Fleet Enema Saline and active ingredients (OSP) are not mentioned on the front of the box. Generic products are similarly labeled. Simply referring to the product as “saline” does not bring attention to the phosphate content in Fleet and similar generic enema products. Since health professionals and consumers often define the term “saline” as a mixture of just salt and water, this could be dangerous.

Although the packaging may meet federal requirements, many pharmacists believe these medication labels are misleading and have a potential to result in patient harm if people fail to recognize the phosphate content. Although the “Drug Facts” section of the label lists phosphates as active ingredients, too often consumers fail to read this important information.

Consumers who use OTC products must always read the Drug Facts section of the label. With Fleet Enema products, read and follow label directions, which state that using more than one enema in 24 hours can be harmful.

Created on September 3, 2013

Medication Safety Alerts

FDA Safety Alerts

Show Your Support!

ISMP needs your help to continue our life saving work