FDA backs controversial drug Vytorin for kidney patients

(CBS/AP) Patients with chronic kidney disease often face other problems, including heart failure and stroke. Vytorin to the rescue?

The FDA says Merck's popular cholesterol drug helps reduce cardiovascular problems in patients with kidney disease and found no new safety concerns with the drug - which has been heavily scrutinized since 2008 for potential cancer risks.

"Risk of cancer did not increase consistently over time with longer use," the FDA researchers wrote in their review, Reuters reported.

Merck has asked the FDA to approve the drug for a new use in reducing heart-related problems chronic kidney disease patients.

The $2-billion-a-year drug - which combines the cholesterol pills Zocor and Zetia - is already cleared to reduce bad cholesterol.

The FDA says that Vytorin cut kidney disease patients' heart-related problems by 16 percent compared with placebo. Results varied depending on whether patients were receiving dialysis - a standard treatment for patients with late-stage kidney disease. Patients on dialysis only saw a six percent drop in heart problems, compared with a 22 percent reduction for healthier patients who weren't on dialysis.

On Wednesday, the FDA will ask advisers to comment on the disparity and to vote on the overall safety and effectiveness of Vytorin for kidney disease patients.

Vytorin has hit a few road bumps on its climb to become one of the top-selling cholesterol drugs.

In July 2008, a study found Vytorin was not effective preventing worse major cardiovascular problems in people with heart valve disease, CBS News reported. The study also showed that Vytorin increased the risk for cancer.

An FDA review eventually found no evidence of a link between Vytorin and cancer, it said in a written statement.

The Mayo Clinic has more on Vytorin.