Salix Pharmaceuticals, the manufacturer of Visicol & OsmoPrep – sodium phosphate monobasic monohydrate and sodium phosphate dibasic anhydrous tablets – may be the subject of product liability lawsuits now that the FDA has linked the products to possible kidney failure and required it to include a black box warning on the products.
Black Box Warning
The U.S. Food & Drug Administration (FDA) required Salix to include a black box warning (the harshest warning available) on Visicol and OsmoPrep, its oral sodium phosphate (OSP) products that are used to clean the bowels before having a colonoscopy, after receiving reports that the products have been linked to acute nephropathy – which may result in permanent impairment of renal (kidney) function that may require long term dialysis or result in death.
Some of the potential risk factors for injury reportedly include:
- active colitis, a condition which affects the tissue that lines the gastrointestinal system
- baseline kidney disease
- hypovolemia, a state of decreased blood volume
- increased age
- increased bowel transit obstruction
- use of medications that affect renal perfusion or function such as diuretics, angiotensin-converting enzyme inhibitors, angiotensin-receptor blockers and possibly non-steriodal anti-inflammatory drugs.
Lawsuits filed
Numerous lawsuits have been filed against a pharmaceutical company which manufactures over the counter versions of these drugs. C.B. Fleet (link to article entitled Oral Sodium Phosphate Lawsuits Increase; Company Requests MDL submitted 5/13/09) manufactures over the counter bowel preps, Fleet Phospho-soda and Fleet
Phospho-soda EZ-Prep. The company pulled their products off the market shortly after the FDA issued the black box warning on Salix’s drugs – which are both prescription drugs. However, Salix has yet to recall its products and some legal experts believe that lawsuits will eventually be filed against Salix as well.
Additional information on Visicol & OsmoPrep
Both Visicol and OsmoPrep are prescribed to cleanse the bowels prior to a colonoscopy in adults 18 years or older. For additional information on the products, see the manufacturer’s website or the FDA’s warning. If you’ve been injured due to OSPs, contact an experienced products liability attorney to discuss your situation and evaluate your options.
