FDA Warns Of Laxatives
January 10, 2014

FDA Warns Of Potentially Fatal Effects Of Laxatives

Brett Smith for redOrbit.com - Your Universe Online

Citing 13 deaths connected to the use of sodium phosphate laxatives, the US Food and Drug Administration (FDA) is cautioning that the constipation-relieving drugs should be used in strict accordance with all directions and warnings.

The federal agency said the drugs should be taken as a single dose once per day and used for no more than three days. If consumers do not have a bowel movement after taking a single dose, they should not take another, the FDA warned.

According to the FDA’s Dr. Mona Khurana, a pediatric kidney expert, the most serious damage seen in the report is due to consumers taking a single dose that was higher than the recommended amount specified on the drug label or took multiple doses in a day because the first dose produced less than optimal results.

"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 said.

The FDA also said that consumers should talk to health care professionals before using these laxatives if they have kidney disease, heart issues or dehydration. Those who are taking drugs that affect the kidneys – such as diuretics, blood pressure medications or nonsteroidal anti-inflammatory drugs (NSAIDs) – should also consult a healthcare professional before taking the laxatives.

Recent reviews by the agency have found 54 cases of severe side effects due to the oral or rectal use of OTC sodium phosphate laxatives. Thirteen cases resulted in death, including one child and twelve adults.

"It is not possible to determine the precise rate of these events as no one knows how many individuals who take these medications may experience side effects," Khurana said. "Not everybody who develops problems in association with sodium phosphate use reports to the FDA."

"Caregivers should not give these products orally to children under age 5 years without first asking a health care professional,” she added. “Both caregivers and health care professionals should avoid the rectal use of these drug products in children under age 2 years. These warnings against use in young children are listed on product labeling."

Laxatives come in different formulations and can be administered orally or rectally. Sodium phosphate used in some of these products promotes a bowel movement by bringing water into the lower intestine, which softens the stool and makes it easier to pass.

The FDA said consumers taking this type of laxative should look for signs of a bad reaction. For example, a rectal dose that does not generate a bowel movement may cause dehydration and disrupt blood chemistry. Symptoms of dehydration include dry mouth, lowered urine output, and lightheadedness, especially when moving. If the rectal dose is held in the body more than 30 minutes, a healthcare professional should be contacted immediately.

Khurana said if consumers have concerns about using the products, they should take to a healthcare professional first.