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FDA Warns Consumers to Use Laxatives With Caution

The Food and Drug Administration (FDA) is now warning consumers about the dangers of some over-the-counter (OTC) laxatives. The laxatives consumers have been turning to for relief have been found to be potentially dangerous if dosing instructions or warnings on the Drug Facts label are not properly followed or when they are taken by people with other health conditions.

There have been dozens of reports of serious side effects, including 13 deaths, associated with the use of sodium phosphate laxatives.

Information about Laxatives and Their Purpose

  • Laxatives are used to relieve constipation, which is marked by infrequent bowl movements or difficulty passing stools.
  • Laxatives are taken both orally and rectally and come in different forms, with different ingredients. In some products sodium phosphate is used; a class of medications called saline laxatives. This class of laxatives helps promote a bowel movement by drawing water into the bowel, which softens the stool, making it easier to pass.
  • The products containing sodium phosphates are marketed under the brand name “Fleet” and are also sold under store brands and as generic products. All of them are potentially associated with serious side effects, including dehydration and/or abnormal levels of electrolytes in the blood. This can lead to serious complications, such as kidney damage and sometimes death.

The Issue with the Lack of Proper Labeling

The label of sodium phosphate laxatives currently states that the laxative should be used as a single dose, and not for more than three days. Also, if you do not have a bowel movement after taking an oral or rectal dose, you should not take another dose.

In addition, the labeling instructs consumers to ask health care professionals before using these products if they have kidney disease or heart problems. This information is crucial and the problem arises when users do not follow directions correctly.

New Warnings for Laxatives

The FDA is now warning that adults older than 55 and adults and children with certain health conditions should ask a health care professional before using these products as they may be at an increased risk for injury. This applies to adults and children who:

  • are taking certain drugs that affect how the kidneys work, such as diuretics or fluid medicines; angiotensin-converting enzyme (ACE) inhibitors used to lower blood pressure; angiotensin receptor blockers (ARBs) used to treat high blood pressure, heart, or kidney failure; and nonsteroidal anti-inflammatory drugs (NSAIDs), such as ibuprofen; or,
  • have inflammation of the colon.
65 Injuries, 13 Deaths Linked to Laxatives

According to Mona Khurana, M.D., a medical officer in FDA’s Division of Nonprescription Regulation Development, the most serious harm occurred when consumer overdosed, in the ways mentioned above.

Khurana goes on to state that the products are safe for otherwise healthy adults and older children as long as they follow the label instructions. Khurana advises that the products not be given to children under 5 years of age without first asking a health care professional, and that caregivers should avoid rectal use of the products in children under 2 years of age.

Recently, in the reviews of harmful side effects reported by consumers and health care professionals, FDA has identified 54 cases of serious side effects associated with OTC sodium phosphate products. Thirteen cases were fatal, including one child and 12 adults.

Consumers taking these laxatives should watch for the following signs of a bad reaction:

  • Rectal dose that is retained and does not produce a bowel movement. This may cause dehydration and/or serious changes in blood electrolyte levels.
  • Symptoms of dehydration include: dry mouth, thirst, reduced urine output, lightheadedness, especially with changes in position.
  • If rectal does is retained in the body longer than 30 minutes, contact a health care professional immediately.
  • Symptoms of kidney injury include drowsiness, sluggishness, a decreased amount of urine, or swelling of the ankles, feet, and legs.
Contact an Experienced Product Liability Attorney

Thomas J. Henry are leaders in the area of drug and product liability litigation. Our Defective Drug and Products Division have extensive knowledge and resources in order to represent our clients efficiently and aggressively. The Defective Drug and Products Division represent a multitude of people who are battling against manufacturers of medical devices and/ or defective pharmaceuticals.

If you or a loved one have been injured by or have developed serious side-effects from the use of defective medications or medical devices, contact Thomas J. Henry immediately. We represent clients/victims all over the country. We are available 24/7, nights and weekends.

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