FDA Puts Boxed Warning About Renal Toxicity on Two Bowel Prep Products

[Guest guest]

Two prescription bowel-cleansing agents that contain oral

sodium phosphate will carry boxed warnings on their labels about potential

acute kidney injury, the FDA announced today. The agency said it was acting after 20 reports

of kidney injury, including three biopsy-proven cases of acute phosphate

nephropathy, received since 2006. Afected are Visicol and OsmoPrep, both sold by Salix Pharmaceuticals. Bowel

prep products based on polyethylene glycol were not affected by the announcement.

The two products' manufacturer will also

be required to develop a risk mitigation strategy and conduct research on the

incidence of kidney injury related to the products. In addition, the agency recommended that

patients avoid high, bowel-cleansing doses of over-the-counter sodium phosphate

products such as Fleet Phospho-Soda……….

Joyce Korvick, M.D., deputy director of FDA's gastroenterology

products division, said the risks may be associated with insufficient hydration…………………………

http://www.medpagetoday.com/ProductAlert/Prescriptions/12124

Barb in Texas - Together in the Fight - Whatever it

Takes!

Son Ken (34) UC 91 PSC 99, LTX 6/21 & 6/30 2007

@ Baylor/Dallas

[Guest guest]

Well, that's disappointing. I guess I'll never get

a chance now (only one kidney).'

Arne

Barb Henshaw wrote:

Two prescription

bowel-cleansing agents that contain oral

sodium phosphate will carry boxed warnings on their labels about

potential

acute kidney injury, the FDA announced today. ...Visicol and OsmoPrep both sold by Salix

Pharmaceuticals. Bowel

prep products based on polyethylene glycol were not

affected by the announcement...

[Guest guest]

Well, that's disappointing. I guess I'll never get

a chance now (only one kidney).'

Arne

Barb Henshaw wrote:

Two prescription

bowel-cleansing agents that contain oral

sodium phosphate will carry boxed warnings on their labels about

potential

acute kidney injury, the FDA announced today. ...Visicol and OsmoPrep both sold by Salix

Pharmaceuticals. Bowel

prep products based on polyethylene glycol were not

affected by the announcement...