Sunday, August 30, 2015

Fleet Enema label misleads - it's not just "saline"

In 2006 the FDA warned consumers about kidney failure seen in some users of oral sodium phosphates (OSP) like Fleet’s Phospho-soda. FDA’s review of adverse event data did not show kidney problems when these over-the-counter oral products were used at lower doses for laxative use. But they did notice that higher doses typically used for bowel cleansing were causing serious harm. Since then, FDA required that manufacturers change the label. The use of OSP for bowel cleansing has been discontinued.

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

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In 2006 the FDA warned consumers about kidney failure seen in some users of oral sodium phosphates (OSP) like Fleet’s Phospho-soda. FDA’s review of adverse event data did not show kidney problems when these over-the-counter oral products were used at lower doses for laxative use. But they did notice that higher doses typically used for bowel cleansing were causing serious harm. Since then, FDA required that manufacturers change the label. The use of OSP for bowel cleansing has been discontinued.

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.

In March, 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.


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President, Institute for Safe Medication Practices
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Check Up is a blog for savvy health consumers, covering the latest developments, discoveries, and debates from the Philadelphia area and beyond.

Portions of this blog may also be found in the Inquirer's Sunday Health Section.

Charlotte Sutton Health and Science Editor, Philadelphia Inquirer
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Marie McCullough Inquirer Staff Writer, cancer and women's health
Michael R. Cohen, R.Ph. President, Institute for Safe Medication Practices
Daniel R. Hoffman, Ph.D. President, Pharmaceutical Business Research Associates
Hooman Noorchashm, M.D., Ph.D. Cardiothoracic surgeon in the Philadelphia area
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