Fleet Laxatives Linked with Serious Kidney Injury and Other Side Effects
Several over-the-counter Fleet laxative products have been recalled by C. B. Fleet Company after the Food and Drug Administration (FDA) received more than 20 reports of kidney injury caused by the products, including acute phosphate nephropathy — a serious type of renal damage.
The recall includes laxative products marketed under the names of Fleet Phospho-soda, Fleet ACCU-PREP, Fleet EZ Prep, and Fleet Phospho-soda EZ Prep Bowel Cleansing System.
Fleet Phospho-soda Black Box Warning
Fleet laxatives are over-the-counter oral sodium phosphate products commonly reserved for prescription use in preparation for bowel cleansing in surgery patients.
The FDA issued its first warning about Fleet Phospho-soda laxatives in May 2006, and continued to increase the severity of its warnings until December 2008, when a black box warning (the FDA’s sternest warning) was issued for the products. In response to the black box warning, C.B. Fleet Company issued a voluntary recall of its products; however, the company is now considering re-releasing the under-fire laxatives to market. If C.B. Fleet Company does return the products to the U.S. market, it must repackage the laxatives — in accordance FDA regulation — to properly highlight the risk of kidney damage.
Severe Kidney Damage and Fleet Phospho-soda Products
Many patients who have taken the Phospho-soda oral laxative products have developed signs of acute kidney injury, which include:
- Abdominal pain
- Decreased urine volume
- Difficulty concentrating
- Edema (swelling of ankles, feet and legs)
- Metallic taste in the mouth
In more severe cases, patients develop acute phosphate nephropathy, an accumulation of calcium-phosphate within the renal tubules that leads to acute renal failure.
The FDA has identified several risk factors for developing debilitating kidney failure after taking Fleet laxatives, including:
- Active colitis
- History of kidney disease
- Aged 55 years and older
- History of bowel obstruction(s)
- Use of diuretics, ACE inhibitors, ARBs, and NSAIDs
Filing a Fleet Phospho-soda Lawsuit
Many believe that C.B. Fleet Company failed to properly warn consumers of the potentially life-threatening side effects of their products, leaving the company liable for damages caused by Fleet laxatives.
If you have developed kidney injury after administering Fleet Phospho-soda products, you may be entitled to recover compensation for your medical expenses and emotional burden. To learn more about filing a Fleet lawsuit, contact the Pensacola personal injury attorneys of AWKO Law at (844) 794-7402 today.