FDA adds warning to Vytorin

Cholesterol drugs Vytorin and Zetia will add depression to lists of possible side effects in their prescribing information, U.S. regulators said yesterday.

The Food and Drug Administration approved the addition of depression to a list of "adverse reactions" seen in patients who took Zetia, according to letters posted on the agency's Web site. Zetia, made by Schering-Plough Corp., is combined with Merck & Co. Inc.'s Zocor to form Vytorin.

Vytorin has been under scrutiny since a study last month suggested that it did not reduce the buildup of plaque in arteries any better than the cheaper Zocor alone. Reports of depression have been known for years and do not indicate a new risk, Schering-Plough spokesman Lee Davies said yesterday.

"This is just a standard update" to the package inserts, Davies said. "My understanding is that there are no new reports" of depression in patients.

Schering-Plough, of Kenilworth, N.J., and Merck, of Whitehouse Station, N.J., had about $5 billion in sales last year from Vytorin and Zetia. Zocor is sold as low-cost simvastatin by many makers of generic drugs.

Prescriptions have fallen since the report comparing Vytorin and Zocor, though the companies say its findings have been mischaracterized.